A Prospective, Multi-Center Study of the Braive™ Growth Modulation System When Used in the Treatment of Pediatric Patients Diagnosed With Juvenile or Adolescent Idiopathic Scoliosis
Phase: NA
Conditions: Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis
Sponsor: Medtronic Spinal and Biologics

Page 1 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
 
Clinical Investigation Plan 
 
Clinical Investigation Plan/Study Title A Prospective, Multi‐Center Study of the 
Medtronic Braive™ Growth Modulation System 
When Used in the Treatment of Pediatric Patients 
Diagnosed with Juvenile or Adolescent Idiopathic 
Scoliosis (BRAIVE IDE Study) 
Clinical Investigation Plan Identifier MDT19009SD1901 
EUDAMED number will be provided under a 
separate cover, when applicable 
Study Product Name Braive™ Growth Modulation System (Braive™ 
GMS) 
Sponsor/Local Sponsor Medtronic Sofamor Danek USA, Inc. 
1800 Pyramid Place 
Memphis, TN 38132 
USA 
Local sponsor – EU Legal Representative: 
Medtronic Bakken Research Center BV 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
Local Sponsor ‐ Canada: 
Medtronic of Canada ULC. 
99 Hereford St. 
Brampton, ON 
L6Y 0R3 
Canada 
+1‐905‐460‐3800 
Document Version 7.0 
Version Date 07 June 2023 

Page 2 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Medical Expert 
 
Medical Advisor 
 
 
 
 
Lead Principal Investigators A. Noelle Larson, MD 
Mayo Clinic 
200 First St SW 
Rochester, MN 
United States 
Andrew J. Bowey, MD 
Newcastle upon Tyne NHS Foundation Trust 
Hospitals 
Tyne and Wear 
NE7 7DN 
United Kingdom 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 
 
 

Page 3 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
1. Investigator Agreement and Signature Page 
 
 
Study product Name 
Braive™ Growth Modulation System 
Sponsor/Local sponsor 
Medtronic Sofamor Danek USA, Inc. 
Local sponsor Europe: 
Medtronic Bakken Research Center BV 
Local sponsor Canada: 
Medtronic of Canada ULC 
Clinical Investigation Plan Identifier 
MDT19009SD1901 
Version Number/Date 
7.0 / 07 June 2023 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for 
me and my staff to conduct this study as described. I will conduct this study as outlined herein and 
will make a reasonable effort to complete the study within the time designated. 
I agree to comply with all applicable regulations and guidelines under which the study is being 
conducted, e.g., United States Food and Drug Administration regulations (In US, 21 CFR part 11, 50, 54 
and 812 apply and in Europe/Canada 21 CFR part 11 and 54 apply), International Standard 
ISO14155:2020 and ethical principles that have their origin in the Declaration of Helsinki 2013 and the 
clinical trial agreement. 
I agree to conduct the study in compliance with country, local and internal institutional requirements. 
I agree to ensure that the confidential information contained in this document will not be used for 
any purpose other than the evaluation and conduct of the clinical investigation without the prior 
written consent of Medtronic. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
Investigator’s Signature: 
Investigator’s Name: 
Institution: 
Date: 
 
 

Page 4 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
Table of Contents 
 
1. Investigator Agreement and Signature Page ............................................................................. 3 
2. Glossary ....................................................................................................................................... 9 
3. Synopsis .................................................................................................................................... 11 
4. Introduction .............................................................................................................................. 17 
4.1. Background ................................................................................................................................. 17 
4.2. Purpose ...................................................................................................................................... 19 
5. Objectives and Endpoints .......................................................................................................... 19 
5.1. Objectives ................................................................................................................................... 19 
5.1.1. Primary Objective ............................................................................................................................ 19 
5.1.2. Primary Safety Objective ................................................................................................................. 19 
5.1.3. Secondary Safety Objectives ............................................................................................................ 20 
5.1.4. Additional Secondary Objectives .................................................................................................... 20 
5.2. Endpoints .................................................................................................................................... 20 
5.2.1. Primary Safety Endpoint ................................................................................................................. 20 
5.2.2. Secondary Safety Endpoint ............................................................................................................. 20 
5.2.3. Additional Secondary Endpoints ..................................................................................................... 20 
6. Study Design ............................................................................................................................. 21 
6.1. Duration...................................................................................................................................... 21 
6.2. Rationale..................................................................................................................................... 22 
7. Product Description ................................................................................................................... 24 
7.1. General ....................................................................................................................................... 24 
7.2. Route of Administration ................................................................................................................ 27 
7.3. Manufacturer ............................................................................................................................... 28 
7.4. Packaging ................................................................................................................................... 28 
7.5. Intended Population ..................................................................................................................... 28 
7.6. Equipment .................................................................................................................................. 28 
7.7. Product Use ................................................................................................................................. 29 
7.8. Product Training Requirements ..................................................................................................... 29 

Page 5 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
7.9. Product Receipt and Tracking ....................................................................................................... 29 
7.10. Product Storage ......................................................................................................................... 29 
7.11. Product Return .......................................................................................................................... 30 
7.12. Product Accountability ................................................................................................................ 30 
8. Selection of Subjects ................................................................................................................. 31 
8.1. Study Population ......................................................................................................................... 31 
8.2. Subject Enrollment ....................................................................................................................... 31 
8.3. Inclusion Criteria ......................................................................................................................... 31 
8.4. Exclusion Criteria ......................................................................................................................... 31 
9. Study Procedures ...................................................................................................................... 32 
9.1. Schedule of Events ...................................................................................................................... 32 
9.1.1. Enrollment ....................................................................................................................................... 34 
9.1.2. Pre-op .............................................................................................................................................. 34 
9.1.3. Surgery ............................................................................................................................................ 35 
9.1.4. Discharge Assessment ..................................................................................................................... 35 
9.1.5. Post-operative Assessment at 3, 6, 12, 18, 24 months and annually ............................................. 35 
9.2. Diagnostic Tests .......................................................................................................................... 36 
9.2.1. Spirometry Assessment ................................................................................................................... 36 
9.2.2. Radiographic Assessment ............................................................................................................... 36 
9.2.3. O-Arm™ Imaging System and Stealth Station Image Acquisition ................................................... 36 
9.2.4. Intraoperative Image Acquisition .................................................................................................... 37 
9.2.5. Risser Score ..................................................................................................................................... 37 
9.2.6. Pregnancy Testing ........................................................................................................................... 37 
9.3. Subject Consent .......................................................................................................................... 38 
9.4. Assessment of Safety ................................................................................................................... 39 
9.4.1. Primary Safety Endpoint ................................................................................................................. 39 
9.4.2. Secondary Safety Endpoint ............................................................................................................. 39 
9.4.3. Adverse Events ................................................................................................................................ 39 
9.4.4. Neurological Status ......................................................................................................................... 40 
9.4.5. Overcorrection ................................................................................................................................ 40 

Page 6 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
9.4.6. Subsequent Spinal Surgical Intervention ........................................................................................ 41 
9.5. Assessment of Effectiveness ......................................................................................................... 42 
9.5.1. Radiographic secondary endpoints ................................................................................................. 42 
9.5.2. PedsQL (Pediatric Quality of Life Inventory™) ................................................................................ 43 
9.5.3. SRS-22 ............................................................................................................................................. 43 
9.6. Imaging Guidelines ...................................................................................................................... 43 
9.7. Recording Data ............................................................................................................................ 44 
9.8. Deviation Handling ....................................................................................................................... 45 
9.8.1. Request for approval of study deviations ....................................................................................... 45 
9.8.2. Reporting requirements for study deviations ................................................................................. 46 
9.8.3. Amendments to the Clinical Investigation Plan .............................................................................. 46 
9.9. Subject Withdrawal or Discontinuation .......................................................................................... 47 
9.9.1. Withdrawal of consent .................................................................................................................... 47 
9.9.2. Lost to follow up.............................................................................................................................. 48 
10. Risks and Benefits ................................................................................................................... 48 
10.1. Potential Risks ........................................................................................................................... 48 
10.2. Risk Minimization ....................................................................................................................... 49 
10.2.1. Overall Mitigation Factors ............................................................................................................. 49 
10.2.2. During Surgery ............................................................................................................................... 50 
10.2.3. During Post-operative Care ........................................................................................................... 50 
10.2.4. Oversight of Safety ........................................................................................................................ 51 
10.2.5. Warning and Precautions .............................................................................................................. 51 
10.3. Potential Benefits ....................................................................................................................... 52 
10.4. Risk-Benefit Rationale ................................................................................................................ 52 
11. Adverse Events and Device Deficiencies ................................................................................. 53 
11.1. Definitions/Classifications ........................................................................................................... 53 
11.2. Reporting of Adverse Events ....................................................................................................... 57 
11.3. Not reportable events ................................................................................................................. 59 
11.4. Device Deficiencies .................................................................................................................... 60 
11.5. Reporting Adverse Events to Medtronic ....................................................................................... 60 
11.6. Pregnancy Reporting .................................................................................................................. 62 

Page 7 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
11.7. Deaths ...................................................................................................................................... 62 
12. Data Review Committees ........................................................................................................ 62 
12.1. Data Monitoring Committee ........................................................................................................ 63 
12.2. CRO / Core labs ......................................................................................................................... 63 
13. Statistical Design and Methods ............................................................................................... 63 
13.1. Analysis of Baseline Data ............................................................................................................ 63 
13.2. Sample Size ............................................................................................................................... 64 
13.3. Primary Analysis Population ........................................................................................................ 64 
13.4. Analyses for Additional Secondary Endpoints ............................................................................... 64 
13.5. Missing Data Considerations ....................................................................................................... 64 
13.6. Safety Analysis .......................................................................................................................... 64 
13.6.1. Primary Safety Endpoint ............................................................................................................... 65 
13.6.2. Secondary Safety Endpoint ........................................................................................................... 65 
13.6.3. Adverse events .............................................................................................................................. 65 
13.6.4. Neurological status ....................................................................................................................... 65 
13.6.5. Subsequent Spinal Surgical Interventions ..................................................................................... 66 
14. Ethics ....................................................................................................................................... 66 
14.1. Statement of Compliance ............................................................................................................ 66 
14.2. Institutional Review Board (IRB) / Ethics Committee (EC) / Research Ethics Board (REB) ............... 67 
14.3. Principal Investigator Obligation .................................................................................................. 67 
14.4. Oversight of Study Personnel ...................................................................................................... 67 
14.5. Medtronic Representative Role .................................................................................................... 68 
15. Study Administration .............................................................................................................. 69 
15.1. Site Activation............................................................................................................................ 69 
15.2. Monitoring ................................................................................................................................. 69 
15.3. Data Management ..................................................................................................................... 70 
15.4. Direct Access to Source Data/Documents .................................................................................... 71 
15.5. Confidentiality ........................................................................................................................... 71 
15.6. Liability ..................................................................................................................................... 72 
15.6.1. Financing and Insurance ................................................................................................................ 72 
15.6.2. Center for Medicare and Medicaid Services (CMS) IDE Study Criteria ......................................... 72 

Page 8 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
15.7. CIP Amendments ....................................................................................................................... 72 
15.8. Record Retention ....................................................................................................................... 72 
15.9. Publication and Use of Information ............................................................................................. 73 
15.10. Suspension or Early Termination ............................................................................................... 73 
15.10.1. Planned Study Closure ................................................................................................................ 73 
15.10.2. Early Termination or Suspension ................................................................................................ 73 
16. Records and Reports ............................................................................................................... 74 
16.1. Responsibilities of the Investigator .............................................................................................. 74 
16.2. Responsibilities of Medtronic ....................................................................................................... 77 
16.3. Final Report ............................................................................................................................... 82 
17. Contact Information................................................................................................................ 82 
17.1. Sponsor contact information ....................................................................................................... 82 
17.2. Participating Investigators and Investigation Sites ........................................................................ 82 
17.3. Reviewing Institutional Review Board .......................................................................................... 83 
18. History ..................................................................................................................................... 84 
19. References ............................................................................................................................ 107 
 
 
 

Page 9 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
2. Glossary 
 
 
Term 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AIS 
Adolescent Idiopathic Scoliosis 
APPT 
Adolescent Pediatric Pain Tool 
AVBT 
Anterior Vertebral Body Tethering 
CIP 
Clinical Investigation Plan or Protocol 
DD 
Device Deficiency 
DSM‐5 
Diagnostic and Statistical Manual of Mental Disorders 5 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EEA 
European Economic Area 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
GMS 
Growth Modulation System 
IC 
Informed Consent 
ICH 
International Conference on Harmonization 
IDE 
Investigational Device Exemption 
Idiopathic Scoliosis 
A lateral curvature of the spine that occurs during growth, the 
cause of which is unknown. 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
IRB/EC/REB 
Institutional review board/ethics committee/research ethics 
board 

Page 10 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
ISO 
International Organization for Standardization 
JIS 
Juvenile Idiopathic Scoliosis 
MEDDEV 
Medical Device Directives 
Medtronic 
Medtronic Sofamor Danek USA, Inc. 
PedsQL 
Pediatric Quality of Life Inventory™ 
PHI 
Protected Health Information 
Protocol 
Clinical Investigation Plan 
SADE 
Serious Adverse Device Effect 
RA 
Regulatory Authority 
RDC System 
Remote Data Capture System 
REB 
Research Ethics Board 
SAE 
Serious Adverse Event 
SID 
Subject Identification 
SQV 
Site Qualification Visit 
SRS‐22 
Scoliosis Research Society 22 Patient Questionnaire 
TPD 
Therapeutic Products Directorate 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
VAS 
Visual Analog Scale 
VBT 
Vertebral Body Tethering 
 
 

Page 11 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
3. Synopsis 
 
 
Title 
A Prospective, Multi‐Center Study of the Braive™ Growth Modulation System When 
Used in the Treatment of Pediatric Patients Diagnosed with Juvenile or Adolescent 
Idiopathic Scoliosis (BRAIVE IDE Study) 
Clinical Study 
Type 
Interventional, prospective, multi‐center, single‐arm study 
Product Name 
Braive™ Growth Modulation System (Braive™ GMS) 
Sponsor 
Medtronic Sofamor Danek USA, Inc. 
1800 Pyramid Place 
Memphis, TN 38132 USA 
 
Local sponsor– EU Legal Representative 
Medtronic Bakken Research Center BV 
Endepolsdomein 5 
6229 GW Maastricht The 
Netherlands 
Local Sponsor (Canada)  
Medtronic of Canada ULC. 99 
Hereford St. 
Brampton, ON L6Y 0R3 
Canada 
External 
Organizations 
Radiographic Review Core Lab (used for eligibility assessment of currently enrolled 
subjects):  
Medical Metrics, Inc 
2121 Sage Road, Suite 300 Houston, 
TX 77056 
USA 
 
This information may be subject to change during the course of the study. Periodic 
updates to study contact information will be sent to study sites as needed. 
Indication under 
Investigation 
The Braive™ GMS is indicated for use in the treatment of juvenile idiopathic scoliosis 
(JIS) or adolescent idiopathic scoliosis (AIS) in skeletally immature patients with Cobb 
angles between 30 and 60 degrees, who have failed conservative care, have a Sanders 
score of ≥2 to ≤5 or a Risser score of 0 to 2, have kyphosis of less than or equal to 40 
degrees with a sagittal thoracic modifier N or negative, and have a Lenke 
Classification of 1A, 1B, or 1C. 
 
In the United States (US) the device will be investigational, and an investigational 
device exemption (IDE) approval was obtained before the study was initiated. 
 

Page 12 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
In Canada, the device will be investigational and an Investigational Testing 
Authorization (ITA) was obtained before the study was initiated. 
 
In Europe the device was CE marked at the time of surgery and therefore the study 
will be conducted within the approved indication. Medtronic has decided to not 
renew EC certification for the Braive GMS 24th March 2023. This decision was not 
based on concerns regarding patient safety. 
Investigation 
Purpose 
The purpose of this study was to establish probable benefits and evaluate the safety 
and preliminary effectiveness of the Braive™ GMS when used in the treatment of JIS 
and AIS. A Humanitarian Device Exemption (HDE) was to be submitted to FDA when 
all available 24‐month follow‐up data had been collected. The collected data were to 
be used to support regulatory applications to seek market approval in US and 
potentially other geographies, and to confirm long‐term clinical performance and 
safety of the CE‐marked Braive™ GMS.  
 
In March 2023, Medtronic made the decision to discontinue the BRAIVE program. All 
sites, therefore, have been notified to discontinue study enrollment and there are no 
plans at this time to utilize collected data to obtain Humanitarian Device Exemption 
(HDE) approval. 
 
This decision is not associated with any safety or efficacy observations from the study, 
and Medtronic has not received stopping recommendations from the Data 
Monitoring Committee or any regulatory bodies. 
Product Status 
Braive™ GMS is investigational in the United States and Canada and it was CE marked 
in countries that require CE at the time of patient surgery. 
Primary Safety 
Objective and 
endpoint 
Considering the BRAIVE program closure, the primary safety objective is to summarize 
device‐related adverse events up to 24 months. The primary safety endpoint is to 
summarize device-related adverse events up to 24 months.  
Secondary Safety 
Objective and 
endpoint 
The secondary safety objectives of the study are to assess all the secondary endpoints 
listed here. 
o Procedure-related adverse events up to 24 months 
o Secondary Spinal surgeries related to the original study device up to 
24 months 
o Device deficiency up to 24 months 
 
(Note: “secondary spinal surgeries” and “subsequent spinal surgical interventions” 
are used interchangeably throughout the document). 
 In addition, all data will be summarized up to skeletal maturity. 
Additional 
Secondary 
Endpoints 
 
 The following is the list of additional secondary endpoints of this study: 
 
• 
Change from baseline in main thoracic Cobb angle at all available 
postoperative time points Change from baseline in proximal thoracic Cobb 
angle at all available postoperative timepoints 
• 
Change from baseline in thoracolumbar/lumbar Cobb angle at all available 

Page 13 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
postoperative timepoints 
• 
Change from post-op baseline in Instrumented Cobb Angle at all available 
postoperative time points. 
• 
Change from baseline in thoracic kyphosis at all available postoperative 
timepoints 
• 
Change from baseline in Lumbar Lordosis at all available postoperative 
timepoints  
• 
Change from baseline in coronal balance at all available postoperative 
timepoints 
• 
Change from baseline in Sagittal Balance at all available postoperative 
timepoints 
• 
Change from baseline in total vertical thoracic spine height (T1‐ T12) at all 
available postoperative timepoints 
• 
Change from baseline in total vertical spine height (T1‐S1) at all available 
postoperative timepoints 
• 
Change from baseline in Scoliosis Research Society‐22 Patient 
Questionnaire (SRS‐22) at all available postoperative timepoints 
Status of return to full activity within 3 months per SRS‐22 
Study Design 
This is a prospective, multi‐center, single‐arm study of the Braive™ GMS. Eligibility 
requirements for the study require that subjects have failed conservative care. The 
baseline measurements will be collected prior to implantation of the device and 
compared against the measurements collected postoperatively. Data will be 
evaluated for safety and patient outcome. 
Subjects will continue to be followed through skeletal maturity. 
Clinical assessments will be completed at a preoperative visit, during surgery, at 
discharge, and postoperatively at 3 months, 6 months, 12 months, 18 months, and 24 
months and then annually until the subject is skeletally mature (defined as Risser 5 as 
assessed by the investigator). Radiographic assessments will be completed at 
baseline, prior to hospital discharge, and at all follow‐up time points. 
Sample Size 
The initial calculated sample size was 25 subjects at 10 sites across the US, Europe 
and Canada.  
When enrollment was stopped in March 2023, 10 subjects had been implanted with 
the Braive™ GMS at 4 sites across the US, Europe, and Canada. No more subjects will 
be enrolled after March 2023.  
Inclusion/ 
Exclusion Criteria 
A subject must meet ALL of the following inclusion criteria to participate: 
• 
Has a diagnosis of juvenile or adolescent idiopathic scoliosis 
• 
Is skeletally immature with a Sanders Score of ≥2 to ≤5 
• 
Has failed conservative care as per investigator’s assessment 
• 
Has a main thoracic Cobb angle between 30 and 60 degrees 
• 
Has a Lenke Classification of 1A, 1B, or 1C 
• 
Has kyphosis ≤40 degrees with a sagittal thoracic modifier N or negative 
• 
Informed Consent Form/Assent and Authorization to Use and Disclose 
Health Information (if applicable) have been signed by Parent/legal guardian 

Page 14 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
and/or patient/participant per local requirement. 
A subject will be excluded from participating in this study for ANY of the following 
reasons: 
• 
Has undergone previous spinal fusion procedure(s) at the affected levels 
• 
Is pregnant or plans to become pregnant within the first 24‐ months of the 
study 
• 
Has a curve that requires instrumentation below L1 
• 
Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater 
than 4mm, tethered cord) 
• 
Has any type of non‐idiopathic scoliosis 
• 
Has a left‐sided curve 
• 
Has an associated syndrome 
• 
Has a history of malignant hyperthermia 
• 
Has 
an 
active 
or 
significant 
risk 
of 
infection 
(immunocompromised) 
• 
Has inadequate tissue coverage over the operative site as per investigator’s 
assessment 
• 
Has a suspected or documented allergy or intolerance to implant materials 
• 
Has a major psychiatric disorder/ history of drug abuse that would interfere 
with the subject’s ability to comply with study instructions or might 
confound the study interpretation as per investigator’s assessment (DSM‐5 
can be used as a reference) 
• 
Is a ward of the court/state 
• 
Has had prior ipsilateral or contralateral chest surgery 
• 
Has severe chronic lung disease (e.g., asthma, bronchiectasis) 
• 
Has poor bone quality, as determined by the investigator, that may limit 
anterior fixation 
• 
Is unwilling or unable to return for follow‐up visits and/or follow intra‐
operative and/or post‐operative instructions 
• 
Concurrent participation in another clinical study that may add additional 
safety risks and/or confound study results* 
 
*Subjects in concurrent studies can only be enrolled with permission from Medtronic. 
Please contact Medtronic’s study manager to determine if the subject can be enrolled 
in the BRAIVE IDE Study. 
Study Procedures 
and Assessments 
Clinical assessments will be completed at baseline (preoperatively), during 
surgery, and postoperatively at discharge, 3 months, 6 months, 12 months, 18 
months and 24 months and then annually until subjects reach skeletal maturity 
(defined as Risser 5 as assessed by the investigator). Radiographic assessments 
will be completed at pre‐op, prior to hospital discharge, and at all study follow‐
up visits. All subjects will be followed until skeletally mature. 
 

Page 15 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Informed Consent/Assent must be obtained prior to performing any study specific procedure. 
1 A pregnancy test will be administered to all female subjects of child‐bearing potential within 72 hours 
prior to surgery. 
2 Adverse events, device deficiencies and subsequent spinal surgical interventions are collected at intervals 
and as reported regardless of follow‐up interval. 
3 The surgery procedure should occur as soon as possible after the eligibility report has been received from 
Study Activity 
PreOp 
Surgery (Day 0) 
Discharge 
3 Mos. 
6 Mos. 
12 Mos. 
18 Mos. 
24 Mos. 
Annually 4 
Unscheduled visit 
Visit Window (Days) 
±30 
±30 
±90 
±90 
±90 
±182 
 
Inclusion/Exclusion Criteria 
X 
Informed Consent / Assent 
X 
Demographics 
X 
Medical History 
X 
Physical Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
 
PedsQL 
X 
 
 
 
 
 
 
SRS‐22 
X 
 
X 
X 
X 
X 
X 
X 
 
Neurological Status 
X 
X 
 
 
 
 
 
 
 
Spirometry 
X 
 
 
Pregnancy Test1 
X 
Operative Information 
X 
Adverse Events and device 
deficiencies2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Subsequent Spinal Surgical 
Interventions2 
X 
X 
X 
X 
X X 
X 
X 
Study Deviations 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study Exit 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Radiographic Procedures 
X‐Ray P/A Thoracolumbar Spine3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X‐ray Neutral lateral 
Thoracolumbar Spine3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X‐ray P/A Right Lateral Bending 
Spine3 
X 
X‐ray P/A Left Lateral Bending 
Spine3 
X 
 
 
 
 
 
 
 
 
 
X‐ray P/A Left Hand3 
X 
 
 
 
 
 
 
 
 
 
MRI 
X 
 
 
 
 
 
 
 
 
 
StealthStation DICOM5 
 
X 
 
 
 
 
 
 
 
 
Intraoperative image6 
 
X 
 
 
 
 
 
 
 
 
Risser Score 
 
 
 
 
 
 
 
X7 
X7 
 
Radiographic assessments as per 
the Radiographic Evaluation 
Protocol8 
X 
 
X9 
X 
X 
X 
X 
X 
X 
X 

Page 16 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
the imaging vendor but no later than 3 months after the date of acquiring the X‐ray images. 
4 After 24 months, subjects will be followed until skeletal maturity is reached (defined as Risser 5 as 
assessed by the investigator). 
5 StealthStation DICOM collection is only applicable to study sites using image guidance. 
6 Intraoperative image collection is only applicable to study sites that are not using image 
guidance. 
7 Risser score will be mandatory from 24 months onwards.  
8 Radiographic assessments will be performed by the study site according to their standard of care. 
9 Referred as Post-op baseline or immediate post-op.  
 
Safety 
Assessments 
All AEs will be collected for this study. The relationship between an AE and the device 
and/or procedure, as well as its severity and seriousness, will be assessed by the 
physician/investigator. 
All adverse events will be reviewed by Medtronic safety representative for safety 
assessments.  
 A steering committee and Medtronic medical advisor will monitor the safety of the 
investigational treatment. 
Statistics 
Analysis of Endpoints 
For the primary safety endpoint and secondary safety endpoints, the rate of event 
along with the 2-sided 95% confidence interval will be calculated and presented.  
For the additional secondary endpoints related to the change from the baseline, 
when the distribution of data is approximately normally distributed, the change from 
baseline will be tested using a paired-sample t-test. When the distribution of the data 
is non-normal, a Wilcoxon signed-rank test may be used in place of the paired t-test. 
In addition, the descriptive statistics including but not limited to mean, standard 
deviation, median, minimum and maximum will be calculated and presented. For 
“Status of return to full activity within 3 months per SRS‐22”, the number and 
percentage of subjects returned to full activity within 3 months will be calculated and 
presented. 
Analysis Populations 
The primary analysis population will include all subjects who were enrolled and 
underwent the Braive™ GMS surgical procedure. The primary dataset will be used for 
all the analyses.  
 
 
 

Page 17 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
4. Introduction 
 
4.1. Background 
Adolescent Idiopathic Scoliosis (AIS), is a complex three – dimensional structural spine deformity with 
unknown etiology and a prevalence of 1‐4 % of adolescents in the early stages of puberty (1, 2). 
 
The goals of AIS treatment are to improve esthetics, improve quality of life, reduce back pain, improve 
psychosocial well‐being, preventing the risk for curve progression in adulthood, improving breathing 
function, Cobb angle correction and prevention of further treatment in adulthood (3). The absolute goals 
for all patients in every clinical situation are to avoid fusion surgery (3). It was recommended that 
treatment decisions should be individualized, considering the probability of curve progression, based on 
the curve magnitude, skeletal maturity, patient age and sexual maturity (3). 
When focusing on curve progression, Charles et al. described in 2006 that curve pattern, Cobb angle at 
the onset of puberty, and curve progression velocity were strong predictive factors of curve progression. 
Juvenile scoliosis (of curves > 30 degrees) increased rapidly and presented a 100% prognosis for surgery 
for curves > 40 ‐ 45 degrees (4). The time of peak growth velocity was indicated to occur around 11‐13 
years of skeletal age (girls) and 13‐15 years (boys), with nearly 90% of all operated curves progressing 
during this growth phase. For Cobb angles of >40 ‐ 45 degrees in the thoracolumbar region or >50 degrees 
in the thoracic region, there was an increased risk of curve progression in adulthood, and together 
represented 0.1 % of patients with AIS (5). An annual curve progression velocity of 6 ‐ 10 degrees during 
the pubertal growth spurt resulted in a spinal fusion rate of 70%. An increase of 1 degree per month 
represented a 100% risk for spinal fusion surgery (4). 
 
In general,  there  are  three  therapy  options  for  AIS:  observation,  bracing  or  surgical  fixation. A high 
variability in outcome results is reported for both bracing and fusion. Bracing is currently considered the 
primary method for treating moderate AIS during developmental phase of growth. The literature showed 
that bracing significantly decreased the progression of high‐risk curves to the threshold for surgery, when 
the bracing was applied for at least 18 hours per day (6, 7). 
 
Criteria for bracing treatment were 10 years or older, skeletally immature (Risser sign of 0, 1 or 2), and a 
Cobb angle of 25 ‐ 40 degrees, no prior treatment, and if female, either pre‐menarche or less than 1 year 
post‐menarche (8). The (bracing) treatment was observed to be more effective in curves under 30 degrees 
(8). In summary (or in general), publications showed that the success rate for bracing ranged from 52% ‐ 
84% at 4 years follow‐up, with 18% ‐ 50% of curves progressing despite bracing, for Cobb angles of 20 ‐ 40 
degrees. 
 
However, bracing effectiveness was limited by psychosocial impacts, patient’s compliance to the 
treatment and patient preferences for alternative treatments, such as fusion. In addition, progression to 

Page 18 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
surgery was related to immature Risser status and initial curve magnitude, with curves measuring ≥ 30° 
progressing to surgical magnitude in > 50% of the patients (9). 
 
Patients with an increased risk of curve progression during adult life are generally considered for fusion 
surgery if they are skeletally immature and have a Cobb angle of >40–45 degrees in the thoracolumbar 
region or >50 degrees in the thoracic region (5). Surgery was recommended not only based on the Cobb 
angle, but also based on cosmesis, patient preference, and the probability of achieving significant benefit. 
The advantages of spine curve correction were reported to be a high degree of patient satisfaction, as 
measured by SRS‐22 questionnaires (10). Successful long‐term effects on the health‐related quality of life, 
satisfaction, physical function were reported for patients 10‐ 30 years after initial fusion surgery; the 
effects of which were comparable to those observed in a healthy patient population (11‐16). 
 
Many publications describe long‐term risks associated with fusion. Several publications described that 
these risks were mainly related to degenerative changes (11, 17) reduced spinal mobility and muscle 
endurance (13), lowered psychological status (14), increased risk of mid‐ to long‐term complications and 
revision surgery (18), or variability of results depending on the criteria for selective fusion (10, 19). 
 
As an alternative to fusion relative new therapy option for fusionless surgical treatment of AIS is anterior 
vertebral body tethering (AVBT). Anterior vertebral body tethering is a minimally invasive, fusionless 
surgical procedure that aims to preserve motion of the instrumented segments and allow curve 
correction. It is a growth‐modulation technique, which utilizes skeletally immature patients' growth 
potential to attain progressive scoliosis correction (20, 21). AVBT is currently being employed in AIS 
patients with growth remaining (Risser score of 0‐3 and a Sanders digital hand score ≤ 5) in thoracic curves 
measuring 35 ‐ 70 degrees and lumbar curves measuring 30 ‐ 70 degrees (22). Ninety‐one patients have 
been treated with unspecified AVBT devices which were likely Dynesys®, as it is the main AVBT device 
used in clinical practice. These patients had two years of post‐op follow‐up. In addition, another 32 
patients were followed‐up for one year, with a sub‐cohort of 11 were followed‐up for two years, treated 
with Dynesys®. The following AVBT related adverse events were reported: overcorrection in 13/116 
patients (11.2%), with 2 more subjects with possible overcorrection pending curve progression requiring 
fusion in 3 patients with 3 more subjects pending fusion (6/123 subjects). Additionally, the following were 
reported: 4 tether breakages; 1 screw loosening in a subject who grew 17cm; 1 contralateral lumbar tether 
added; 7 with less optimal result; 3 atelectasis, of which two were reported to be resolved with physical 
therapy, and one required posterior spine fusion for lumbar decompensation below the tether. No 
neurological complications or infections were reported. 
 
In conclusion, the current State of the Art (SOTA) treatment for AIS consists of three main options 
(observation, bracing and fusion). The choice of treatment depends on the magnitude of the deformity 
and the risk for curve progression. The time of peak growth velocity was indicated to occur around 11‐13 
years of skeletal age (girls) and 13‐15 years (boys), with nearly 90% of all operated curves progressing 
during this growth phase. Bracing and fusion represent opposite treatment technologies. Bracing 

Page 19 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
maintains the flexibility of the growing spine but depends on the patients’ adherence to (or compliance 
with) the treatment. Fusion achieves a deformity correction already at first erect, but at the cost of a stiff 
immature spine and risk for additional complications later in life. 
 
The AVBT treatment has emerged as an alternative treatment positioned between bracing and fusion. 
The Braive™ GMS is designed as a growth‐modulation, non‐fusion technique, which utilizes patients’ 
remaining growth potential to limit further progression of the curve, to provide correction of the thoracic 
spine, and allow continued growth while maintaining mobility. These results have demonstrated a positive 
benefit / risk ratio by eliminating the need for bracing compliance, reducing the risk for less optimal curve 
correction and maintaining flexibility of the spine. In addition, the need for fusion surgery in patients with 
larger Cobb angles and the associated risk for additional surgery later in life are reduced. 
 
4.2. Purpose 
The BRAIVE IDE Study is a prospective, multi‐center, single‐arm study. The purpose of this study was to 
establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS 
when used in the treatment of JIS and AIS.  
In March 2023, Medtronic made the decision to discontinue the BRAIVE program. All sites, therefore, have 
been notified to discontinue study enrollment and there are no plans at this time to utilize collected data to 
obtain Humanitarian Device Exemption (HDE) approval. This decision is not associated with any safety or 
efficacy observations from the study, and Medtronic has not received stopping recommendations from the 
Data Monitoring Committee. 
 
 
5. Objectives and Endpoints 
 
5.1. Objectives 
 
5.1.1. Primary Objective 
The primary objective of the study is to summarize the safety data . 
 
5.1.2. Primary Safety Objective 
Considering the BRAIVE program closure, the primary safety objective is to summarize the Device‐related 
adverse events up to 24 months follow up. 
The summary will be based on both Investigators and Medtronic relatedness assessment.  
 
 

Page 20 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
5.1.3. Secondary Safety Objectives 
The secondary safety objectives of the study are to assess all the secondary safety endpoints listed below 
in section 5.2.2. 
 
5.1.4. Additional Secondary Objectives 
The Additional Secondary objectives of the study are to assess all the secondary endpoints listed below in 
section 5.2.3. 
 
 
 
5.2. Endpoints 
 
5.2.1. Primary Safety Endpoint 
The primary safety endpoint is any device‐related adverse events up to 24 month follow up. 
 
5.2.2. Secondary Safety Endpoint 
 
The secondary safety endpoints are listed below. 
o Procedure-related adverse events up to 24 months 
o Secondary Spinal surgeries related to the original study device up to 24 months 
o Device deficiency up to 24 months 
 
(Note: “secondary spinal surgeries” and “subsequent spinal surgical interventions” are used 
interchangeably throughout the document). 
 
In addition, all data will be summarized up to skeletal maturity.  
 
5.2.3. Additional Secondary Endpoints 
The additional secondary endpoints of this study include: 
 
• 
Change from baseline in main thoracic Cobb angle at all available postoperative time points  
• 
Change from baseline in proximal thoracic Cobb angle at all available postoperative timepoints 
• 
Change from baseline in thoracolumbar/lumbar Cobb angle at all available postoperative 
timepoints 
• 
Change from post-op baseline in Instrumented Cobb Angle at all available postoperative time points. 
• 
Change from baseline in thoracic kyphosis at all available postoperative timepoints 
• 
Change from baseline in Lumbar Lordosis at all available postoperative timepoints  

Page 21 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Change from baseline in coronal balance at all available postoperative timepoints 
• 
Change from baseline in Sagittal Balance at all available postoperative timepoints 
• 
Change from baseline in total vertical thoracic spine height (T1‐ T12) at all available postoperative 
timepoints 
• 
Change from baseline in total vertical spine height (T1‐S1) at all available postoperative timepoints 
• 
Change from baseline in Scoliosis Research Society‐22 Patient Questionnaire (SRS‐22) at all 
available postoperative timepoints 
• 
Status of return to full activity within 3 months per SRS‐22 
  
 
6. Study Design 
 
This is a prospective, multi‐center, single‐arm study of the Medtronic Braive™ GMS. Eligibility 
requirements for the study require that subjects have failed conservative treatment as per investigator’s 
assessment. The baseline measurements will be collected prior to implantation of the device and 
compared against the measurements collected postoperatively. Subjects will continue to be followed until 
skeletally mature. 
 
The initial calculated sample size was 25 subjects at 10 sites across the US, Europe and Canada. A 
maximum of 5 subjects (20% of original population target) were to be enrolled and treated at a single site, 
to mitigate bias by limiting the number of subjects per site. When enrollment was stopped in March 2023, 
10 subjects had been enrolled and treated at 4 sites, across the US, Europe and Canada.  
 
 Investigational sites were selected based on experience and expertise in managing patients with JIS and 
AIS, ability to recruit subjects and comply with the protocol and regulations, and clinical research expertise 
and resources. Investigators selected to participate in this clinical study are responsible for fulfilling the 
requirements of the investigator’s agreement and investigational plan. All investigators signed an 
investigator agreement prior to initiation of screening or enrollment activities. 
 
Only consented subjects were enrolled into the study. Sites were requested to make every effort to enroll 
subjects in a consecutive manner. Clinical assessments are scheduled at baseline (preoperatively), during 
surgery, and postoperatively at discharge, 3 months, 6 months, 12 months, 18 months and 24 months and 
then annually until subjects reach skeletal maturity (defined as Risser 5 as assessed by the investigator). 
Radiographic assessments are scheduled at pre‐op and prior to hospital discharge, and at all study follow‐ 
up visits. All subjects will be followed until skeletally mature. 
 
6.1. Duration 
Enrollment in the study for each subject is defined as the date the parents/legal guardian and subject sign 
the informed consent/assent (as applicable). 

Page 22 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Enrolled subjects who did not undergo the BraiveTM GMS procedure as defined in this protocol could be 
exited (removed) from the study and be replaced when enrollment was still open. In such cases the 
Medtronic study manager had been contacted for guidance as to whether to exit the subject or not. The 
completion of the study is defined as the conclusion of the follow‐up visit when the subject is skeletally 
mature (Study Exit). Each subject’s participation in the study is expected to last from the date of the 
procedure until the subject is skeletally mature. Consequently, the total participation time in the study 
will vary for each subject. Each subject is evaluated prior to the procedure (baseline), during the 
procedure, prior to hospital discharge, and 3 months, 6 months, 12 months, 18 months and 24 months 
post procedure and then annually until skeletal maturity is reached (defined as Risser 5 as assessed by the 
investigator). 
 
The expected duration of the study is approximately 8 years, including approximately 18 months for 
subject enrollment. The study is considered complete when all subjects have reached skeletal maturity 
(defined as Risser 5 as assessed by investigators). 
 
6.2. Rationale 
Figure 1 shows the spectrum of treatment options incorporating the Braive™ GMS. Conservative care, 
which primary consists of bracing, is often effective in treating small, flexible curves. Bracing does not 
correct the curve; rather it is intended to halt the progression of the curve. Studies have shown that the 
longer the brace is worn each day, the better the potential outcome (6). However, bracing has several 
disadvantages. The braces are often cumbersome, visible, and must be worn a minimum of 18 hours a 
day for several years, often resulting in a high rate of non‐compliance by the young patients, especially 
with the psychosocial ramifications present in today’s society (6, 23). Non‐compliance leads to treatment 
failure, especially in patients with larger, stiffer curves. Thus, studies have reported that bracing has been 
shown to have a high rate of variable outcomes (24, 25). Further, while alternative treatments to bracing, 
such as physical therapy, electrical stimulation or chiropractic care, may provide symptom relief or core 
strengthening, these treatments have not been scientifically proven to treat or prevent curve progression 
(26). 
 
If conservative care does not halt the curve progression, there are other treatment options: vertebral 
body tethers (VBT) like the Braive™ GMS, growing rods, and fusion surgery. Growing rods are used to treat 
a different population of scoliosis patients compared to Braive™ GMS. Growing rods are used for patients 
less than 10 years of age with severe scoliosis (curves > 60 degrees), while the Braive™ GMS is intended 
for patients with less severe, progressive scoliosis (curves 30 ‐ 60 degrees) who have growth potential 
remaining. Patients with an increased risk of curve progression during adult life are generally considered 
for fusion surgery (fusion of the spine with rigid instrumentation to correct the deformity) if they are 
skeletally immature and have a Cobb angle of >40 ‐ 45 degrees in the thoracolumbar region   or 
>50 degrees in the thoracic region (5). Fusion surgery can result in reduced spinal growth and decreased 
spinal mobility that can negatively impact the quality of life for AIS patients and require further treatments 

Page 23 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
throughout their life. According to Crawford & Lenke, 2010 (27), fusion procedures do generate some 
concerns, which include “the cessation of spinal growth over the fused segments (which may negatively 
affect pulmonary function) and the potential for disc degeneration of segments adjacent to a long fusion 
construct. Since non‐operative treatment does not control progression in all cases, the search for 
alternative treatment of juvenile idiopathic scoliosis is warranted.” The main concerns with traditional 
posterior instrumentation and fusion in skeletally immature patients with scoliosis include: correction 
loss, crankshaft phenomenon, implantation failure and lack of spinal growth (28). 
As an alternative to fusion, anterior vertebral body tethering (AVBT) has emerged as a relatively new 
therapy option for fusionless treatment of JIS or AIS. AVBT is a minimally invasive, fusionless surgical 
procedure that aims to preserve motion of the instrumented segments and allow curve correction. 
Specifically, the Braive™ GMS is intended to limit further progression of the curve, to provide correction 
of the thoracic spine, and allow continued growth while maintaining (spinal) mobility (or flexibility). As 
described in the background section, while some patients have been treated with AVBT devices, the 
purpose of this study is to establish probable benefit and evaluate the safety and preliminary effectiveness 
of the Braive™ GMS as an alternative to the treatments discussed above and as it fills a treatment gap for 
patients who have failed conservative care and are not yet appropriate patients for fusion surgery. For 
this reason, no control group is implemented for this study and where needed the comparison with 
bracing and fusion literature will be made. Additionally, as the Braive™ GMS preserves motion in the spine 
while allowing curve correction, it may address some of the risks associated with the treatment of patients 
who progress to fusion surgery. 
 
 
 
 
 
Figure 1: Spectrum of Treatment Options for Idiopathic Scoliosis 
Conservative 
Care 
Conservative 
Care Effective 
Conservative Care 
Not Effective 
(Surgery Required) 
No Surgery 
Required 
Vertebral Body 
Tethering 
 
Fusion Surgery 
Vertebral Body 
Tethering 
Effective 
Vertebral Body 
Tethering Not 
Effective 
Fusion Surgery 

Page 24 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
 
 
7. Product Description 
 
 
7.1. General 
The Braive™ GMS is an implantable device being evaluated for use in the treatment of JIS or AIS in 
skeletally immature patients with Cobb angles between 30 and 60 degrees, who have failed conservative 
care, have a Sanders score of ≥2 to ≤5, have kyphosis ≤40 degrees with a sagittal thoracic modifier N or 
negative, and have a Lenke Classification of 1A, 1B, or 1C. 
 
The Braive™ GMS is intended to limit further progression of the curve, provide correction of the thoracic 
spine, and allow continued growth while maintaining mobility. The system consists of the following 
components: Braid, Fixed Angle Screws (FAS), Plate, and Break‐Off Set Screw. The system is designed such 
that first the Plate and then FAS are implanted into the bone (or vertebral body). The Braid is then inserted 
into the slot of the screw and the Set Screw is threaded into the FAS (to secure the Braid in place). Per 
vertebral level 3 components are implanted and the different levels are connected to each other by 1 
Braid. On average it is expected that the subject will require 6 to 8 levels implanted. The system is 
implanted using an anterior thoracoscopic approach across multiple vertebral levels (usually five to 
seven). The implants are placed along the lateral vertebral wall on the convex side of the scoliotic curve. 
Figure 2 includes images of the implant assembly and the implanted construct on the anterior‐lateral side. 
The system can be implanted freehand or through image guidance using Medtronic’s O‐Arm ™ Surgical 
Imaging System and Medtronic Stealth Station™. 
 
 
 
Figure 2: Screw Plate Assembly (left) and Anterior Lateral Braid Placement (right) 

Page 25 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
The design of the Braive™ GMS is based on the Hueter‐Volkmann principle in which the rate of epiphyseal 
growth is affected by pressures applied to its axes. As such, decreased stress on the growth plate leads to 
an increased growth rate and an excessive stress leads to growth retardation. AVBT has become a general 
term to describe such a procedure when applied to the vertebrae of the spinal column. 
For Medtronic’s Braive™ GMS, compression is applied to the convex side of the scoliotic curve using a 
flexible braid, which is affixed to the anterior spinal column using metallic vertebral body screws, plates 
and set screws. The applied compression modulates growth on the convex side of the curve and allows 
the continued growth of the concave side of the curve, resulting in the concave side “catching up” and 
correcting the deformity (Figure 3). 
 
 
 
 
Figure 3: Braive™ GMS, compression applied on convex side of the curve. 
 
The Braive™ GMS consists of the components and corresponding material composition outlined in Table 
1. 
 
Table 1. Braive™ GMS Implantable Components and Material Composition 
 
Component 
Material Composition 
Fixed Angle Screws (FAS) 
Titanium Alloy (Ti‐6Al‐4V) 
Plate 
Titanium Alloy (Ti‐6Al‐4V) 
Break‐off Set Screw 
Titanium Alloy (Ti‐6Al‐4V) 
Braid 
UHMWPE Fibers 
 
A description of the different implants and available sizes is provided in Table 2 and 3. An overview of the 
different instruments is provided in Table 4. 

Page 26 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
Table 2. Braive Metal Implant Set 
 
PART TYPE 
Investigational 
CFN 
CE mark CFN 
DESCRIPTION 
Sterile 
FAS 
677105520 
777105520 
5.5X20MM SELF‐TAPPING FAS 
STERILE 
FAS 
677105522 
777105522 
5.5X22.5MM SELF‐TAPPING FAS 
STERILE 
FAS 
677105525 
777105525 
5.5X25MM SELF‐TAPPING FAS 
STERILE 
FAS 
677105527 
777105527 
5.5X27.5MM SELF‐TAPPING FAS 
STERILE 
FAS 
677105530 
777105530 
5.5X30MM SELF‐TAPPING FAS 
STERILE 
FAS 
677105532 
777105532 
5.5X32.5MM SELF‐TAPPING FAS 
STERILE 
FAS 
677105535 
777105535 
5.5X35MM SELF‐TAPPING FAS 
STERILE 
FAS 
677105540 
777105540 
5.5X40MM SELF‐TAPPING FAS 
STERILE 
FAS 
677105545 
777105545 
5.5X45MM SELF‐TAPPING FAS 
STERILE 
FAS 
677106520 
777106520 
6.5X20MM SELF‐TAPPING FAS 
STERILE 
FAS 
677106522 
777106522 
6.5X22.5MM SELF‐TAPPING FAS 
STERILE 
FAS 
677106525 
777106525 
6.5X25MM SELF‐TAPPING FAS 
STERILE 
FAS 
677106527 
777106527 
6.5X27.5MM SELF‐TAPPING FAS 
STERILE 
FAS 
677106530 
777106530 
6.5X30MM SELF‐TAPPING FAS 
STERILE 
FAS 
677106532 
777106532 
6.5X32.5MM SELF‐TAPPING FAS 
STERILE 
FAS 
677106535 
777106535 
6.5X35MM SELF‐TAPPING FAS 
STERILE 
FAS 
677106540 
777106540 
6.5X40MM SELF‐TAPPING FAS 
STERILE 
FAS 
677106545 
777106545 
6.5X45MM SELF‐TAPPING FAS 
STERILE 
Set Screw 
677501000 
777501000 
BREAKOFF SET SCREW 
STERILE 
Plate 
677603000 
777603000 
PLATE 
STERILE 
 
Table 3. Braive Braid Implant Set 
 
PART TYPE 
Investigational 
CFN 
CE mark CFN 
DESCRIPTION 
Sterile 
Braid 
677700000 
777700000 
UHMWPE BRAID 
STERILE 
Braid 
677700750 
777700750 
UHMWPE BRAID LONG 
STERILE 
 
Table 4. Braive Instrument Set 
 
PART TYPE 
Investigational 
CFN 
CE mark CFN 
SAP DESCRIPTION 
Sterile 
Navigated 
Instrument 
NAV677000008 
NAV777000008 
NAVIGATED AWL‐PLATE HOLDER 
NO 
Instrument 
677000008 
777000008 
AWL‐PLATE HOLDER 
NO 

Page 27 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Navigated 
Instrument 
NAV677000014 
NAV777000014 
NAVIGATED FAS DRIVER 
NO 
Instrument 
677000014 
777000014 
FAS DRIVER 
NO 
Instrument 
677000015 
777000015 
FAS HEAD POSITIONER 
NO 
Instrument 
677000016 
777000016 
3MM ASSEMBLY BOLT 
NO 
Instrument 
677000020 
777000020 
SET SCREW BREAK‐OFF 
NO 
Instrument 
677000021 
777000021 
OBTURATOR 
NO 
Instrument 
677000026 
777000026 
BLUNT‐TIP PROBE 
NO 
Instrument 
677000028 
777000028 
BRAID GRASPER 
NO 
Instrument 
677000029 
777000029 
DEPTH GAUGE 
NO 
Instrument 
677000034 
777000034 
PROVISIONAL DRIVER 
NO 
Instrument 
677000035 
777000035 
COUNTER TORQUE 
NO 
Instrument 
677000037 
777000037 
PLATE TEMPLATE 
NO 
Instrument 
677000041 
777000041 
PLATE HOLDER 
NO 
Instrument 
677000023 
777000023 
TENSIONER 
NO 
Handle 
G900000 
G900000 
Quick Connect Ratcheting Handle 
NO 
Handle 
9339012 
9339012 
Egg Handle 
NO 
Handle 
7578011 
7578011 
Threaded Handle 
NO 
 
 
Table 5: Braive Licensing Disc 
 
PART TYPE 
Investigational 
CFN 
CE mark CFN 
SAP DESCRIPTION 
Sterile 
Software 
Part 
9736353 
9736313 
BRAIVE Licensing Disc 
NO 
 
 
The Braive™ GMS is investigational in the US and Canada and will be labeled as such. The label will be 
provided separate from this CIP. Outside the US, the Braive™ GMS was CE marked, at the time of the 
surgeries and is labeled as such. Labeling will be provided in local language for CE marked devices. The CE 
marked devices will be used within intended use as described in the approved IFU for which CE mark has 
been obtained. In countries where no market release is obtained, the use of the Braive™ GMS is limited 
to the clinical investigation and according to the Clinical Investigation Plan. Instructions for Use are 
available separate from this CIP. 
 
Medtronic has decided to not renew CE certification for the Braive GMS on 24th March 2023. This decision 
was not based on concerns regarding patient safety. 
 
7.2. Route of Administration 

Page 28 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Information regarding the surgical technique for implantation of the device is provided in the Surgical 
Technique and the Navigated Surgical Technique that are available separate from this CIP. 
 
7.3. Manufacturer 
Medtronic Sofamor Danek USA, Inc 
1800 Pyramid Place 
Memphis, TN 38132 
USA 
 
7.4. Packaging 
All study implants will be provided in an intact sterile package provided by the sponsor and will be clearly 
labeled sterile. The instruments as listed in Table 4 will be provided non‐sterile in metal sets to the clinical 
sites. Investigational devices will be labeled according to local requirements as per local authorities. Please 
refer to the IFUs that are available separate from this CIP for additional information regarding packing and 
labeling of the study devices and instruments. 
 
CE marked devices will be labelled in respective local language. 
 
7.5. Intended Population 
The Braive™ GMS is indicated for use in the treatment of JIS or AIS in skeletally immature patients with 
Cobb angles between 30 and 60 degrees, who have failed conservative care, have a Sanders score of ≥2 
to ≤5, have kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative, and have a Lenke 
Classification of 1A, 1B, or 1C. 
The Braive™ GMS is intended to limit further progression of the curve, to provide correction of the 
thoracic spine, and allow continued growth while maintaining mobility. 
 
7.6. Equipment 
Imaging: The site should have the ability to perform or access to equipment or facility to perform the 
following: Posterior/Anterior, Neutral and Lateral Bending radiographs, and MRI as applicable.  
Sites will be able to choose to implant the system non navigated according to the standard Surgical 
Technique or navigated following the Navigated Surgical Technique (both Surgical Techniques are 
available separate from this CIP). Study sites intending to implant the system using image guidance shall 
have access to Medtronic’s O‐Arm Surgical Imaging System and Medtronic StealthStation. O‐Arm and 
StealthStation are recommended to be used according to their applicable instructions for use. Study 
sites using image guidance will be provided a licensing disc to access the BraiveTM GMS in navigated 
views.  

Page 29 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Any test equipment critical to be used for assessing safety endpoints (X‐ray) will be 
maintained/calibrated according to the manufacturer’s specifications. Maintenance and calibration 
reports will be monitored periodically by the monitor for images collected at study sites.  
 
7.7. Product Use 
The Braive™ GMS will be used according to the surgical technique provided separately from this CIP. The 
operating surgeon should refer to the product’s IFU and the instruments IFUs, provided separately from 
this CIP. 
 
7.8. Product Training Requirements 
To reduce the potential for surgical technique variations, Medtronic will supply a surgical technique to 
describe the implantation of the Braive™ GMS. The Surgical technique (non‐navigated) and the Navigated 
Surgical Technique are provided separate from this CIP. All surgeons will undergo certified training on the 
surgical techniques prior to performing their first implantation of the device and will receive case support 
for the first case and subsequent cases, as needed. 
 
In addition, an interactive educational application will be provided to investigators that will allow access 
to representative examples of curves in the range of the intended patient population. The examples will 
include the pre‐operative Cobb angle, the initial, post‐operative curve correction, and subsequent 
simulations of the growth and curvature over time. This application is intended to illustrate the general 
principle of growth modulation for training purposes. It is not indicative of or based on actual clinical 
outcomes with the BraiveTM GMS. This application is not used to make individual patient treatment 
decisions or to predict patient outcomes. 
 
7.9. Product Receipt and Tracking 
Device accountability logs will be maintained by the sites for the investigational devices and instruments 
and for the CE marked devices and instruments if they are provided free of charge. Investigational and free 
of charge CE marked devices, (navigated) instruments and BRAIVE Licensing Disc will not be shipped to the 
site until receipt and tracking training has occurred, and the investigator has delegated authority to 
personnel to manage receipt and tracking of the devices. Records of shipment and receipt will be 
maintained both at the clinical site and by the sponsor or sponsor’s representative. 
 
7.10. Product Storage 
The investigational devices and instruments will be provided for this study and must be stored in a secure 
location (i.e., limited access area or in a locked cabinet). The principal investigator (or qualified designee) 
must agree not to dispense the devices and instruments from, nor store them at, any site other than the 
study sites designated at the beginning of the study. This section also applies for CE marked devices and 

Page 30 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
instruments provided free of charge. 
 
7.11. Product Return 
Any component that is explanted should be returned for analysis according to Medtronic standard 
procedures for complaint product analysis. Note, this does not include any components that were 
implanted and removed during the initial procedure. These were to be returned to the sponsor or 
sponsor’s representative. The device accountability log should be updated accordingly. Additionally, any 
components where the packaging is not intact or that are opened but not implanted should be returned 
to the sponsor or sponsor’s representative, and the device accountability log should be updated 
accordingly. The Retrieval and Analysis of Explanted Devices protocol provided separate from this CIP is no 
longer applicable. 
 
Upon completion of all surgeries or study completion at the latest, all unused devices including the 
Braive™ Instrument Set and licensing CD will be returned to the sponsor or sponsor’s representative. 
Records of device shipment and receipt will be maintained both at the clinical site and by the sponsor or 
sponsor’s representative. At study completion, the software will need to be deinstalled. 
 
For CE marked devices and instruments that are obtained via the commercial route (not provided free of 
charge) only the explant process applies. 
 
7.12. Product Accountability 
Device accountability logs will be maintained for the components of the devices. Upon completion of the 
study, unused devices must be returned to the sponsor or sponsor’s representative. Records of shipment 
and receipt will be maintained both at the investigational site and by the sponsor or sponsor’s 
representative. 
 
The device accountability log will track at least: 
 
a) the date of receipt and received by name, 
b) identification of each device (lot number/serial number or unique code), 
c) expiry date, if applicable 
d) the date of use, 
e) subject identification, 
f) the date of return and returned by name (including reason for return) 
g) the date on which the device was explanted from the subject and returned for analysis, if 
applicable 
 
Product accountability does not apply for CE marked devices and instruments that are obtained via the 
commercial route (not provided free of charge). 

Page 31 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
 
8. Selection of Subjects 
 
8.1. Study Population 
As reflected in the inclusion and exclusion criteria below, all subjects will have failed conservative 
treatment prior to enrollment in the study. The baseline measurements will be collected prior to 
implantation of the device and compared against the measurements collected postoperatively. 
 
8.2. Subject Enrollment 
Subjects planning to undergo an anterior vertebral tethering procedure with the Braive™ GMS will be 
screened for eligibility to participate in the study. All subjects that are considered for the study should be 
included on the subject screening log. The reason for non‐eligibility should also be recorded on the subject 
screening log. Subjects will be considered enrolled in the study once the informed consent form/assent is 
signed by the parent/legal guardian and/or the subject (as applicable). Those who do not undergo the 
implantation of the Braive™ GMS as defined in this protocol might be exited from the study and can be 
replaced if enrollment is still open. In such cases the Medtronic study manager should be contacted for 
guidance as to whether to exit the subject or not. The initial calculated sample size was 25 subjects. When 
enrollment was stopped in March 2023, 10  subjects had been enrolled and treated with BRAIVE GMS. 
Subjects who receive the study treatment will be considered study subjects. 
 
8.3. Inclusion Criteria 
A subject must meet all of the following inclusion criteria to participate in this study: 
 
• 
Has a diagnosis of juvenile or adolescent idiopathic scoliosis 
• 
Is skeletally immature with a Sanders Score of ≥2 to ≤5 
• 
Has failed conservative care as per investigator’s assessment 
• 
Has a main thoracic Cobb angle between 30 and 60 degrees 
• 
Has a Lenke Classification of 1A, 1B, or 1C 
• 
Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative 
• 
Informed Consent Form/Assent and Authorization to Use and Disclose Health Information (if 
applicable) have been signed by Parent/legal guardian and/or patient/participant per local 
requirement. 
 
8.4. Exclusion Criteria 
A subject will be excluded from participating in this study for any of the following reasons: 
 
• 
Has undergone previous spinal fusion procedure(s) at the affected levels 

Page 32 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Is pregnant or plans to become pregnant within the first 24‐months of the study 
• 
Has a curve that requires instrumentation below L1 
• 
Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord) 
• 
Has any type of non‐idiopathic scoliosis 
• 
Has a left‐sided curve 
• 
Has an associated syndrome 
• 
Has a history of malignant hyperthermia 
• 
Has an active or significant risk of infection (immunocompromised) 
• 
Has inadequate tissue coverage over the operative site as per investigator’s assessment 
• 
Has a suspected or documented allergy or intolerance to implant materials 
• 
Has a major psychiatric disorder/ history of drug abuse that would interfere with the subject’s 
ability to comply with study instructions or might confound the study interpretation as per 
investigator’s assessment (DSM‐5 can be used as a reference) 
• 
Is a ward of the court/state 
• 
Has had prior ipsilateral or contralateral chest surgery 
• 
Has severe chronic lung disease (e.g., asthma, bronchiectasis) 
• 
Has poor bone quality, as determined by the investigator, that may limit anterior fixation 
• 
Is unwilling or unable to return for follow‐up visits and/or follow intra‐operative and/or post‐ 
operative instructions 
• 
Concurrent participation in another clinical study that may add additional safety risks and/or 
confound study results* 
 
*Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact 
Medtronic’s study manager to determine if the subject can be enrolled in the BRAIVE IDE Study. 
 
 
9. Study Procedures 
 
9.1. Schedule of Events 
The study schedule, procedures, and methods of assessment are defined in detail to enable compliance 
with the required activities, and to ensure that the resulting data meet the criteria for evaluability. See 
Table 6 for visit schedule. The relevant electronic Case Report Forms (eCRFs) along with the applicable 
source documentation will be completed for each subject. The case report forms are provided separate 
from this CIP. 
 
 
 
 

Page 33 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
 
Table 6. Schedule of Events 
 
 
 
Informed Consent/Assent must be obtained prior to performing any study specific procedure. 
1 A pregnancy test will be administered to all female subjects of child‐bearing potential within 72 hours prior to surgery. 
2 Adverse events, device deficiencies and subsequent spinal surgical interventions are collected at intervals and as reported regardless 
of follow‐up interval. 
3 The surgery procedure should occur as soon as possible after the eligibility report has been received from the imaging vendor but no 
Study Activity 
PreOp 
Surgery (Day 0) 
Discharge 
3 Mos. 
6 Mos. 
12 Mos. 
18 Mos. 
24 Mos. 
Annually 4 
Unscheduled visit 
Visit Window (Days) 
±30 
±30 
±90 
±90 
±90 
±182 
 
Inclusion/Exclusion Criteria 
X 
Informed Consent / Assent 
X 
Demographics 
X 
Medical History 
X 
Physical Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
 
PedsQL 
X 
 
 
 
 
 
 
SRS‐22 
X 
 
X 
X 
X 
X 
X 
X 
 
Neurological Status 
X 
X 
 
 
 
 
 
 
 
Spirometry 
X 
 
 
Pregnancy Test1 
X 
Operative Information 
X 
Adverse Events and device deficiencies2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Subsequent Spinal Surgical Interventions2 
X 
X 
X 
X 
X 
X 
X 
X 
Study Deviations 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study Exit 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Radiographic Procedures 
X‐Ray P/A Thoracolumbar Spine3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X‐ray Neutral lateral Thoracolumbar 
Spine3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X‐ray P/A Right Lateral Bending Spine3 
X 
X‐ray P/A Left Lateral Bending Spine3 
X 
 
 
 
 
 
 
 
 
 
X‐ray P/A Left Hand3 
X 
 
 
 
 
 
 
 
 
 
MRI 
X 
 
 
 
 
 
 
 
 
 
StealthStation DICOM5 
 
X 
 
 
 
 
 
 
 
 
Intraoperative image6 
 
X 
 
 
 
 
 
 
 
 
Risser Score 
 
 
 
 
 
 
 
X7 
X7 
 
Radiographic assessments as per the 
Radiographic Evaluation Protocol8 
X 
 
X9 
X 
X 
X 
X 
X 
X 
X 

Page 34 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
later than 3 months after the date of acquiring the X‐ray images. 
4 After 24 months, subjects will be followed until skeletal maturity is reached (defined as Risser 5 as assessed by the investigator). 
5 StealthStation DICOM collection is only applicable to study sites using image guidance. 
6 Intraoperative image collection is only applicable to study sites that are not using image 
guidance. 
7 Risser score will be mandatory from 24 months onwards.  
8 Radiographic assessments will be performed by the study site according to their standard of care. 
9 Referred as Post-op baseline or immediate post-op.  
 
 
9.1.1. Enrollment 
All subjects and the parent(s)/legal guardian need to provide their informed consent/assent in accordance 
with the informed consent/assent regulations per geographic region. If the subject agrees to participate 
in the study, he/she and/or the parent/legal guardian will be asked to sign the informed consent form 
(ICF)/Assent form (as applicable). Once the ICF/Assent forms are signed, a copy of the signed ICF/Assent 
forms will be provided to the parent/legal guardian and/or the subject. The Informed Consent and Assent 
forms are provided separate from this CIP. 
 
The subject and/or parent or legal guardian must sign the ICF/Assent prior to performing any study specific 
procedure. A subject is considered enrolled in this study at the time the subject and/or parent/legal 
guardian signs the ICF/Assent form. The subject will be assigned a unique, sequential code linked to their 
name, alternative subject identification or contact information. The investigator will maintain a log of all 
subjects enrolled (enrollment log) in the study. The total enrollment for the study is 10 treated subjects. 
 
9.1.2. Pre-op 
The following information will be collected at the preoperative visit: 
• 
Verification of Inclusion/Exclusion criteria 
• 
Demographics 
• 
Medical History 
• 
Physical Assessment (weight and height) 
• 
Imaging (PA, lateral, lateral bending, and left‐hand X‐rays, MRI) 
• 
Radiographic assessments as per standard of care 
• 
PedsQL 
• 
SRS‐22 
• 
Neurological Status 
• 
Pulmonary Function (Spirometry) 
• 
Pregnancy test (administered to all female subjects of child‐bearing potential within 72 hours prior to 
surgery) 
• 
Adverse Events 
• 
Study Deviations 
 

Page 35 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
9.1.3. Surgery 
The surgery procedure should occur as soon as possible after the eligibility report has been received from 
the imaging vendor but no later than 3 months after the date of acquiring the X‐ray images. If the images 
cannot be done within the required window, new images should be obtained. 
The following information should be collected during surgery: 
• 
Surgery procedure data 
• 
Surgery Time 
• 
Blood loss and Transfusion 
• 
Device information 
• 
Adverse Events and/or device deficiencies 
• 
Study Deviations 
• 
StealthStation Images (only collected at study sites using image guidance – standard of care images) 
• 
Intraoperative images (only collected at study sites not using image guidance – standard of care 
images) 
 
It is recognized that a subject might be enrolled but not implanted with the Braive™ GMS due to the 
investigator’s discretion. If this occurs, it shall be documented on a study deviation eCRF, including the 
rationale for not implanting the device and the study exit form will be completed in the eCRF system. 
 
9.1.4. Discharge Assessment 
The following information will be collected at the discharge assessment (at the time of hospital discharge): 
• 
Physical Assessment (weight and height) 
• 
Imaging (P/A and lateral X‐rays) 
• 
Radiographic assessments as per standard of care 
• 
Neurological Status 
• 
Adverse events and/or device deficiencies 
• 
Study Deviations 
 
9.1.5. Post-operative Assessment at 3, 6, 12, 18, 24 months and annually 
The following information will be collected at 3‐month, 6‐month, 12‐month, 18‐month, 24‐month post‐ 
operative visits and annually thereafter until skeletal maturity is reached: 
• 
Physical Assessment (weight and height) 
• 
SRS‐22 
• 
Imaging (PA and lateral X‐rays)   
• 
Radiographic assessments as per standard of care 
• 
Adverse Events and/or device deficiencies 
• 
Study Deviations 

Page 36 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Risser score (only required on and after 24 months) 
 
9.2. Diagnostic Tests 
 
The following medical imaging and laboratory assessments will be performed during the study. 
 
9.2.1. Spirometry Assessment 
Pulmonary function will be assessed at the pre‐operative visit by collecting the following parameters: 
• 
Forced Vital Capacity (FVC) 
• 
Forced Expiratory Volume in one second (FEV1) 
• 
Total Lung Capacity 
 
9.2.2. Radiographic Assessment 
Images collected will be evaluated by investigators for adverse event, device deficiency and additional 
secondary endpoints analysis. The following series of radiographs will be obtained per the Schedule of 
events. 
• 
P/A Thoracolumbar Spine 
• 
Neutral Lateral Thoracolumbar Spine 
• 
P/A Right Lateral Bending Spine 
• 
P/A Left Lateral Bending Spine 
• 
P/A Left Hand 
• 
StealthStation DICOM 
• 
Intraoperative AP fluoroscopy 
With the early enrolment stop, the decision was taken to use Core Lab assessments for patient eligibility 
assessment only. The remaining radiographic assessments will be performed by the study sites as per their 
standard of care. For relevant endpoints, study site will follow the Radiographic Evaluation Protocol for 
radiographic measurements. The Radiographic Evaluation Protocol is maintained separate from this CIP. 
 
9.2.3. O-Arm™ Imaging System and Stealth Station Image Acquisition 
Sites using image guidance in the procedure workflow may have imaging collected from Medtronic O‐Arm 
Surgical Imaging System and Medtronic StealthStation. Images being obtained off the systems are from 
the procedure workflow following the Navigated Surgical Technique. The StealthStation DICOM will be 
obtained per the Schedule of Events for potential future use: 
• 
To confirm the post‐operative position of the Braive™ GMS System 
• 
To verify the amount of correction achieved by the Braive™ GMS System during surgery 
• 
To further develop the Braive™ GMS System and the surgical technique 
• 
To develop future capabilities that improve O‐arm™ Imaging System image quality, reduce X‐ray dose 

Page 37 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
to the patient, and aid in the development of segmentation and other algorithms/features that can 
enhance a surgeon or radiologist’s decision‐making ability 
• 
To develop future capabilities that improve algorithmic segmentation of anatomy and aid in new 
development or enhancement of current surgical planning features for Medtronic platforms (i.e., 
StealthStation™, Mazor X™ Stealth Edition, BraiveSim) 
• 
To validate a patient‐specific computer modeling software that will generate patient‐specific 
simulations of growth and curvature over time (only applicable for those patients that provide 
separate consent for this since the data may need to be shared with an external vendor) 
 
9.2.4. Intraoperative Image Acquisition 
For sites that are not using image guidance, intraoperative AP fluoroscopy images will be collected before 
and after implantation of the Braive™ system during surgery to: 
• 
Confirm the post‐operative position of the Braive™ System 
• 
To verify the amount of correction achieved by the Braive™ GMS System during surgery 
• 
Further development of the Braive™ GMS System and the surgical technique 
• 
To validate a patient‐specific computer modeling software that will generate patient‐specific 
simulations of growth and curvature over time (only applicable for those patients that 
provide separate consent for this since the data may need to be shared with an external 
vendor) 
 
9.2.5. Risser Score 
Risser Score will be assessed by the investigator to evaluate the skeletal maturity of the subject in 
accordance with the following definitions: 
 
Grade 0: No iliac apophysis visible. 
Grade 1: Initial appearance of ossification of the iliac apophysis. 
Grade 2: Migration halfway across the top of the iliac wing. 
Grade 3: Three-fourths of the distance. 
Grade 4: Ossification crossing the iliac wing, but not fused to the ilium. 
Grade 5: Complete ossification of the iliac apophysis with fusion to the ilium. 
When grade 5 is reached on or after 24-month follow up visit, subject will be exited from the study.  
 
9.2.6. Pregnancy Testing 
All subjects of childbearing potential must receive a pregnancy test (urine or serum test) within 72 hours 
prior to the study surgery. If the result of the pregnancy test is positive, the subject will be withdrawn 
from the study prior to surgery and will not receive the study treatment. 

Page 38 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
9.3. Subject Consent 
The informed consent process in this study will be conducted in compliance with the Informed Consent 
regulations in 21 CFR 50 (US only), Declaration of Helsinki 2013, ISO 14155:2020 and national/local data 
protection laws and regulations. All subjects and/or parents/legal guardians for this study will be provided 
with an Informed Consent/Assent (as applicable) describing this study and providing sufficient information 
to make an informed decision about the subjects’ participation in this study. The Informed Consent and 
Assent templates will be submitted with the protocol for review and approval by an IRB/EC/REB and the 
Regulatory Authorities, where applicable. 
The investigator or authorized designee must obtain written informed consent/assent from the subject 
and/or parent(s)/legal guardian before any clinical study related activity takes place. Prior to entering the 
study, the investigator, or his/her designee, will inform all potential subjects and parent(s)/legal guardian  
about all aspects of the study (e.g., the purpose and nature of the study, procedures, potential risks, 
follow‐up schedule, and expected duration). 
All items addressed in the Informed Consent Form/Assent Form must be explained. The language used 
shall be as non‐technical as possible and must be understandable to the subject. 
 
The investigator or designee will discuss the foreseeable risks as well as potential benefits that may result 
from participating in the study and the available alternative therapies. 
 
The subject and/or parent(s)/legal guardian must have ample time and opportunity to read and 
understand the Informed Consent Form/Assent Form, to inquire about details of the clinical study, and to 
decide whether to participate in the clinical study. All questions about the clinical study should be 
answered to the satisfaction of the subject and/or the parent(s)/legal guardian. 
 
Neither the investigator, nor the investigation site staff shall coerce or unduly influence a subject and/or 
parent(s)/legal guardian to participate or to continue to participate in the clinical study. The informed 
consent/assent process shall not waive or appear to waive the subject’s rights. Subjects and/or 
parent(s)/legal guardian will be informed by the investigator or designee that they are free to refuse to 
participate in the study, and if they choose to participate, that they may withdraw from the study at any 
time without compromising further medical care. In addition, subjects and/or parent(s)/legal guardian 
will be informed that the investigator may terminate their participation at any time without their consent. 
Written informed consent/assent will be obtained prior to subject enrollment and before any study‐ 
specific procedures are initiated. 
 
Whenever new information becomes available that may be relevant to the subject’s confirmed 
participation in the clinical study, Medtronic will revise the written Informed Consent Form/Assent Form 
and inform the investigators. The revised information will be sent to the investigator for approval or 

Page 39 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
notification by the IRB/EC/REB and the Regulatory Authorities, where applicable. An approved copy of this 
information must be provided to the participating subjects and/or parent or legal guardian, and the 
informed consent process as described above needs to be repeated. The investigator should inform the 
subject in a timely manner whenever new information becomes available that may be relevant to the 
subject’s confirmed participation in the clinical study. 
 
The investigator or designee will also determine that the subject/parent(s)/legal guardian can read, 
comprehend and make a decision regarding study participation of the subject (as applicable). 
 
The original, signed and dated ICF/Assent Form must be retained in the subject’s study records. The 
informed consent process must be documented in the subject’s medical records and signed copies of the 
ICF/Assent Form will be provided to the subject and/or parent(s)/legal guardian. The date the subject 
and/or parent(s)/legal guardian signed the Informed Consent Form and data protection authorization (if 
applicable), and/or Assent must be documented in the subject’s medical records. 
 
 
9.4. Assessment of Safety 
The criteria outlined in this section will be used to evaluate each subject before, during, and after surgery 
to determine the safety associated with the subject’s treatment and study procedures. The safety of the 
Braive™ GMS will be assessed by evaluating the nature and frequency of AEs and additional surgical 
procedures (such as reoperations, revisions, or removals) and overcorrection. 
 
9.4.1. Primary Safety Endpoint 
The safety endpoint is any device‐related adverse events up to 24 months. For this endpoint, the summary 
will be based on both Investigators and Medtronic relatedness assessment. 
 
9.4.2. Secondary Safety Endpoint 
The secondary safety endpoints are listed below: 
• 
Procedure-related adverse events up to 24 months 
• 
Secondary Spinal surgeries related to the original study device up to 24 months 
• 
Device deficiency up to 24 months 
 
For these endpoints, the summaries will be based on both Investigators and Medtronic relatedness 
assessment. 
 
9.4.3. Adverse Events 

Page 40 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
All AEs will be collected (see section 11 for further details). AEs will be evaluated before, during and after 
surgery to determine the safety associated with the subject’s treatment and study procedures. 
The AEs will be classified according to the classification in Table 7: AE Definitions/Classifications. 
The safety of the investigation will be assessed by evaluating the nature and frequency of AEs and 
subsequent spinal surgical procedures, as well as overcorrection, if applicable. 
A steering committee and Medtronic medical advisor will monitor the safety of investigational treatment. 
All adverse events will be reviewed by a Medtronic safety representative. 
 
9.4.4. Neurological Status 
Neurological status will be evaluated prior to the study treatment and at discharge. Neurological status 
can be performed at the investigator’s discretion according to their standard of care at study follow up 
visits. Abnormalities should be reported as adverse event. 
Neurological status is based on four types of measurements (sections): motor, sensory, reflexes, and 
straight leg raising. Each of the sections is comprised of a number of elements. Following scales will be 
used to evaluate neurological status: reflexes (0 = Absent, 1= Hypo‐reflexia, 2 = Normal, 3 = Hyper‐ 
reflexia), sensory function (Light Touch T1 to S1, 1=Absent, 2=Impaired, 3=Normal), motor function (using 
0‐5 scores whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity 
Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = 
Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = positive, patient 
experiences radiating leg pain below the knee on elevating the leg between 15 and 70 degrees with the 
knee extended, 2 = negative, no pain is experienced on elevating the leg between 15 and 70 degrees with 
the knee extended). 
Neurological change will be defined as deteriorate, maintenance or improvement in all sections (motor, 
sensory, reflex, and straight leg raising) between baseline and discharge. In order for a section to be 
considered a success, each element in the section must remain the same or improve from the time of the 
baseline evaluation to discharge. Therefore, if any one or more elements in any section does not stay the 
same or improve, then a patient will not be considered a success for neurological status. Note: For reflex, 
a change from Hypo‐reflexia to Hyper‐reflexia or a change from Hyper‐ reflexia to Hypo‐reflexia is 
considered as maintained. 
 
9.4.5. Overcorrection 
When the growth modulation occurs at a relatively rapid rate, the spine may grow past a corrected (e.g., 
0 degree or neutral) alignment. This phenomenon is termed overcorrection as it represents an overshoot 
of the desired clinical account of a 0 degree Cobb angle. A negative main thoracic Cobb angle indicates 
reversal of the curve, i.e., from right‐sided to left‐sided curve. 
 

Page 41 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
The risk of overcorrection is mitigated by the following: 
 
• 
Limiting enrollment to subjects with a Sanders Score equal or greater than 2 to allow sufficient 
growth time for the Braive™ GMS to correct the curve without allowing extra time for 
overcorrection. 
• 
Requiring investigators to review the educational tool and to follow the surgical technique. 
• 
The risk reduction is achievable by understanding the potential for a rapid growth spurt (e.g., 
Sanders score) and the surgeon’s control to avoid excessive compression with the Braid (e.g., 
surgical technique). Prior to skeletal maturity, clinically significant overcorrection of the curve 
can be treated by removing the Braid or releasing tension by cutting the Braid, which will 
allow increased growth of the vertebrae on the operated side and may reduce the 
overcorrection. After skeletal maturity, clinically significant overcorrection of the curve can 
be treated by fusion surgery, which is the standard of care for skeletally mature patients who 
have failed bracing and were not treated with vertebral body tether. The potential sequelae 
for overcorrection are the same as those for scoliosis; however, the degree of overcorrection 
curvature is likely to be less than the degree of curvature at baseline. Potential complications 
include: cosmetic such as uneven shoulders, one hip or rib cage prominent, and body tilted 
to one side, low back pain, lower self‐esteem, decreased social functioning, depression, 
persistent pain if there is wear and tear of the spine bones, spinal infection after surgery, 
spine or nerve damage from curve or spinal surgery, and lung and heart problems (in severe 
scoliosis with curves > 70 degrees). 
If overcorrection occurs, it will be at the discretion of the physician, in consultation with the patient and 
family, to determine if surgical intervention is necessary. Overcorrection is considered clinically significant 
if it is greater than 20 degrees and/or if it requires a secondary spinal surgery classified as treatment failure 
and will be considered a device‐related adverse event. 
 
9.4.6. Subsequent Spinal Surgical Intervention 
Some adverse events or treatment failures may lead to additional surgical interventions. Relatedness of 
these subsequent spinal surgical interventions will be assessed as described in the following sections. 
 
9.4.6.1. Types of Subsequent Spinal Surgical Interventions 
Secondary spinal surgeries (equivalent to subsequent spinal surgical interventions) will be classified using 
the definitions as specified in section 11.1 Table 7. 
 
Any subsequent spinal surgical intervention will be reviewed by Medtronic safety to determine whether 
it is a true treatment failure. Subjects with a treatment failure will only be followed up for safety (AEs and 
subsequent spinal surgical interventions) and radiographic imaging (Qualitative assessments only: Risser 
score, device integrity and additional observations) until the patient reaches skeletal maturity.  
 
Total events and total number of subjects who have additional surgeries will be summarized. The numbers 

Page 42 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
of revisions (total, preventive and non‐preventive), removals, reoperations and other surgeries will also 
be summarized. 
 
9.4.6.2. Relatedness of Subsequent Spinal Surgical Interventions 
A relatedness determination will be made by the investigator to the original study device and the original 
study surgery to a subsequent surgical intervention. 
For the purpose of harmonizing reports, each subsequent spinal surgical intervention will be classified 
according to five different levels of causality. The investigator will use the following definitions to assess  
the relationship of the subsequent spinal surgical intervention to the original study device (i.e., 
investigational device), other surgical components, or study procedures. 
 
• 
Not Related: Relationship of the subsequent spinal surgical intervention to the original study 
device or study procedures can be excluded. 
• 
Unlikely: The relationship with the use of the original study device or study procedures seems not 
relevant and/or the event can be reasonably explained by another cause, but additional 
information may be obtained. 
• 
Possible: The relationship with the use of the original study device or study procedure is weak but 
cannot be ruled out completely. Alternative causes are also possible (e.g., an underlying or 
concurrent illness/clinical condition or/and an effect of another device, drug, or treatment). In 
cases where relatedness cannot be assessed, or no information has been obtained, the 
relationship should also be classified as possible. 
• 
Probable: The relationship with the use of the original study device or surgical procedure seems 
relevant and/or the need for a subsequent spinal surgical intervention cannot reasonably 
explained by another cause, but additional information may be obtained. 
• 
Causal Relationship: The event is associated with the original study device or original surgical 
procedure beyond reasonable doubt. 
A subsequent spinal surgical intervention determined as having “possible,” “probable,” or “causal” 
relationship to the Braive™ GMS will be conservatively considered as being “related” to the device. 
 
9.5. Assessment of Effectiveness 
 
9.5.1. Radiographic secondary endpoints 
The radiographic secondary endpoints for this study are listed below. These endpoints are assessed as per 
site standard of care: 
 
• 
Change from baseline in main thoracic Cobb angle at all available postoperative time points  
• 
Change from baseline in proximal thoracic Cobb angle at all available postoperative timepoints 
• 
Change from baseline in thoracolumbar/lumbar Cobb angle at all available postoperative 
timepoints 

Page 43 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Change from post-op baseline in Instrumented Cobb Angle at all available postoperative time points. 
• 
Change from baseline in thoracic kyphosis at all available postoperative timepoints 
• 
Change from baseline in Lumbar Lordosis at all available postoperative timepoints  
• 
Change from baseline in coronal balance at all available postoperative timepoints 
• 
Change from baseline in Sagittal Balance at all available postoperative timepoints 
• 
Change from baseline in total vertical thoracic spine height (T1‐ T12) at all available postoperative 
timepoints 
• 
Change from baseline in total vertical spine height (T1‐S1) at all available postoperative timepoints 
 
9.5.2. PedsQL (Pediatric Quality of Life Inventory™) 
PedsQL will be evaluated prior to the study treatment. 
 
The PedsQL Measurement Model is a modular approach to measuring health‐related quality of life 
(HRQoL) in children and adolescents and those with acute and chronic health conditions. The 23‐item 
PedsQL Generic Core Scales are designed to measure the core dimensions of health as delineated by the 
World Health Organization, as well as role (school) functioning. The 4 Multidimensional Scales are physical 
functioning, emotional functioning, social functioning and school functioning. The 3 Summary Scores are 
Total Scale score, Physical Health Summary score, and the Psychosocial Health Summary score. Two 
versions of this assessment will be filled out, one by the subject and one by the parent or legal guardian. 
Information from these versions will be analyzed separately. 
 
9.5.3. SRS-22 
The SRS‐22 will be evaluated prior to the study treatment and postoperatively at 3 months, 6 months, 12 
months, 18 months, 24 months and annually until skeletal maturity is reached. 
 
The SRS‐22 Patient Questionnaire has become the most widely used patient‐reported outcome (PRO) 
instrument for evaluating individuals with idiopathic scoliosis. The SRS‐22 contains 22 questions covering 
5 domains: function/activity 5 items; pain 5 items; self‐perceived image 5 items; mental health 5 items; 
and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). Each domain has 
a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the 
first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the 
maximum total is 110. 
 
9.6. Imaging Guidelines 
Study subjects are required to undergo imaging procedures at specified time points during the study. To 
ensure consistency in the type and quality of all images obtained throughout this study some 
requirements have been defined: 
 

Page 44 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Clinical sites must use imaging equipment (X‐ray) that are maintained and calibrated according to 
the manufacturer’s specifications when performing imaging procedures on subjects for this study. 
• 
Imaging equipment maintenance and calibration will be monitored. 
• 
To reduce the radiation exposure to study subjects, all X‐ray examinations should be realized at 
the lowest radiation dose that still provides the minimally required image quality. 
A Radiographic evaluation protocol will be kept separate from this document.  
 
9.7. Recording Data 
The investigator must ensure that the data reported in the eCRF and all other required study reports are 
accurate, complete and reported in a timely manner. Data reported on the eCRFs must be consistent with 
the source documents, and discrepancies between the eCRF and source documents need to be justified 
in writing, signed and dated by the investigator, and filed in the subject’s medical file or appropriate 
location. 
Subject neurological status and instrument accountability can be recorded directly on the eCRF and is 
considered source data. All other data entered in the eCRFs should be documented in the subject’s 
medical records/source document (electronic or paper), (e.g., hospital records, surgery reports, x‐rays, 
MRIs, CTs, or any other material that contains original information used for data collection including the 
documentation of AEs and study source document completed by the investigator or site staff). 
Subject/parent(s)/legal guardian completed questionnaires as well as data collected during 
subject/parent(s)/legal guardian phone calls will be considered as source data. 
 
This study will be conducted using a Remote Data Capture (RDC) system. The RDC system allows the study 
centers to enter study data into the sponsor’s database over a secure internet connection. Required data 
will be taken from source documents and directly entered into the study database by authorized site 
personnel in accordance with applicable regulations. 
 
Every attempt should be made to complete the required onsite clinic visit. However, if the subject is 
unable to return to the investigational site for their scheduled follow‐up visit, the study site can contact 
the subject and collect the following data remotely using the source document worksheet: 
• 
SRS‐22 – phone version or web‐based application 
• 
Adverse events and/or device deficiencies 
 
The Principal Investigator or an individual delegated by the Principal Investigator on the Delegation of 
Authority Log is responsible for documenting and entering data for the study on the eCRFs. Only 
authorized site study staff can complete eCRFs. eCRFs shall be signed by the Principal Investigator or Sub‐ 
investigators (physicians only) as specified on the Delegation of Authority Log included in the Investigator 
Site File. The Principal Investigator or delegated Sub‐Investigator is required to approve all data on eCRFs 
via electronic signature. 
 

Page 45 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Procedures used for data review, database cleaning, and issuing and resolving data: 
 
• 
Data will be reviewed using programmed and manual data checks. 
• 
Data queries will be made available to centers for resolution. 
• 
Study management reports may be generated to monitor data quality and study progress. 
 
9.8. Deviation Handling 
A study deviation is an event where the investigator or site personnel did not conduct the clinical study 
according to the Clinical Investigational Plan or Clinical Investigation Agreement. 
The investigator is not allowed to deviate from the above‐mentioned documents except under emergency 
circumstances to protect the rights, safety and well‐being of human subjects. All deviations shall be 
documented in the eCRF and explained, regardless the reason for the deviation. Multiple deviations of 
the same type at the same visit may be reported on one e‐CRF. 
 
Examples of study deviations include but are not limited to: 
• 
Informed Consent procedures 
• 
Enrolled subject does not meet Inclusion/Exclusion criteria for those criteria assessed by the 
investigator. The Radiographic Review Core Lab will perform an independent subject eligibility 
review for the following in/exclusion criteria after the patient has been enrolled: 
o Is skeletally immature with a Sanders Score of ≥2 to ≤5 
o Has a main thoracic Cobb angle between 30 and 60 degrees 
o Has a Lenke Classification of 1A, 1B, or 1C 
o Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative 
In case the patient does not meet any of the in/exclusion criteria as listed above this will not be 
considered a protocol deviation, but the patient will be exited and can be replaced if enrollment 
is still open. 
• 
Visit not done 
• 
Assessment(s) at the visit not performed 
• 
Visit outside the defined visit window 
• 
Subject did not undergo Braive procedure as defined in this protocol 
• 
Improper reporting of AEs, serious adverse events (SAEs), adverse device effects (ADEs), serious 
adverse device effects (USADEs or SADEs) and device deficiencies (DDs). 
• 
IRB/EC/REB approval not obtained, if required 
• 
Is pregnant or becomes pregnant within first 24‐months of the study 
• 
COVID‐19 impact 
 
9.8.1. Request for approval of study deviations 
Prior approval by Medtronic is expected in situations where the investigator anticipates, contemplates, 
or makes a conscious decision to deviate. Prior approval is not required when a deviation is necessary to 

Page 46 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
protect the safety, rights or well‐being of a subject in an emergency or in unforeseen situations beyond 
the investigator’s control (e.g., inability to perform required procedures due to subject inability or illness). 
For medically justifiable conditions which preempt a subject’s ability to complete a study‐required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward. 
This may also apply for other unforeseen situations (e.g., the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary endpoint analysis). However, 
prior approval from Medtronic is required for such situations. 
 
9.8.2. Reporting requirements for study deviations 
The Investigator shall adhere to IRB/EC/REB requirements and procedures for reporting study deviations 
and shall report the deviation as soon as possible to Medtronic. Medtronic is responsible for analyzing 
deviations, assessing their significance, and identifying any additional corrective and/or preventive actions 
(e.g., amend the CIP, additional training, terminate the study, etc.). Repetitive or serious investigator 
compliance issues may result in the need to initiate a corrective action plan, and in some cases, freeze 
enrollment or ultimately terminate the investigator’s participation in the clinical study. 
 
In the event the deviation involves a failure to obtain a subject’s consent or is made to protect the life or 
physical well‐being of a subject in an emergency, the deviation must be reported to the IRB/EC/REB as 
well as Medtronic per IRB/EC/REB and local reporting requirements. Reporting of all other study 
deviations should comply with IRB/EC/REB and Regulatory Authorities (where applicable) policies and/or 
local laws and must be reported to Medtronic as soon as possible upon the center becoming aware of the 
deviation. Medtronic is responsible for reporting all study deviations to Regulatory Authorities as 
applicable. 
 
9.8.3. Amendments to the Clinical Investigation Plan 
The investigator will propose any appropriate modification(s) of the CIP or investigational device or 
investigational device use. Medtronic will review this proposal and decide whether the modification(s) 
will be implemented. 
 
Medtronic will submit any significant amendment to the CIP, including a justification for this amendment, 
to the appropriate regulatory authorities and to the investigators to obtain approval from their 
IRB/EC/REB and Regulatory Authorities, where required by local law/regulations. Administrative 
amendments to the CIP will be submitted to the IRB/EC/REB and appropriate regulatory authorities for 
notification, where required by local law/regulations. 
Furthermore, investigators shall sign any approved amendment for agreement. 
 
 

Page 47 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
9.9. Subject Withdrawal or Discontinuation 
Subjects are free to voluntarily withdraw from the study at any time and for any reason. The Investigator 
can only withdraw a subject from the study with a valid reason. Withdrawn or exited subjects will be 
followed under normal medical practice. Examples of reasons for subject discontinuation include, but are 
not limited to, those listed below: 
• 
Informed Consent procedures not followed 
• 
Subject does not meet all eligibility criteria 
• 
Subject death 
• 
Subject lost to follow‐up 
• 
Subject voluntarily withdraws from the study 
• 
Subject did not undergo the Braive procedure as defined in this protocol 
 
If a subject is withdrawn from the study, the reason for withdrawal (if known) shall be recorded in the 
eCRF and in the subject’s hospital record. 
 
Subjects withdrawn from the study were only replaced when subjects did not meet baseline eligibility or 
did not undergo the Braive procedure as defined in this protocol while the enrollment was still open. 
 
Compliance with the required follow‐up schedule is essential to enable the analysis of the results in a 
scientifically sound and meaningful way. If, for whatever reason, the subject follow‐up visit cannot be 
scheduled within the time window, it is still essential to schedule a follow‐up visit and to document the 
subject data at a date as close as possible to the calculated follow‐up date. 
 
As much as possible, subjects should not be lost‐to‐follow‐up and investigators are urged to do their 
utmost best to maintain subject follow‐up compliance as per CIP. 
 
9.9.1. Withdrawal of consent 
Subjects/parent(s)/legal guardian may withdraw from the study at any time and for any reason. If a subject 
withdraws from the study, the reason for withdrawal will be documented, if given by the 
subject/parent(s)/legal guardian, in the source documents and in the subject’s eCRF. If a subject 
withdraws consent after undergoing the Braive procedure, they will not be replaced. The follow up of 
these subjects will be according to the standard of care at the site. 
 
If a subject withdraws, study staff should make a reasonable effort to determine the reason for the 
subject’s withdrawal from the study and to complete the Exit eCRF. Telephone calls, registered letters, 
and offers of transportation to the investigational site are considered reasonable effort. Documentation 
of communication attempts should be kept in the subject’s chart to document the site’s efforts in securing 
follow‐up compliance. If a subject is withdrawn from the study, any missed visits or remaining evaluations 
will not be considered study deviations. If the subject agrees, he/she is to be followed via 

Page 48 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
telephone/mail/electronic media for the duration of the study to assess for AEs and/or subject survival 
and pregnancy outcome (if applicable). 
 
Subjects who withdraw prior to surgery will not be counted in the total number of treated study subjects 
and will not be included in the efficacy analyses of the data. For subjects who are withdrawn during 
surgery due to an AE, the AE will be recorded on an Adverse Event eCRF and included in a summary of 
subject discontinuations. 
 
9.9.2. Lost to follow up 
Before considering a subject as lost to follow up, the investigator should make every attempt to contact 
the subject and the parent(s)/legal guardian (or relevant other persons associated with the subject) to 
have the subject return for follow‐up to determine their clinical status and the occurrence/resolution of 
AEs, if any. 
 
Before documenting a subject as lost to follow up, the investigator should document in the eCRF and 
source documents at least 3 contact attempts with the subject, subject’s relatives or other persons 
associated with the subject. In addition, the investigator should make a reasonable effort to ascertain the 
reason(s), while fully respecting the subject's rights (e.g., if a subject is deceased, the date of death should 
be completed or if the subject is alive, the date of last contact with subject should be provided). 
 
When subjects are lost to follow‐up the investigator will make efforts to confirm the vital status of the 
subject, as described in the informed consent. 
 
10. Risks and Benefits 
 
10.1. Potential Risks 
Medtronic has conducted a risk analysis for subjects in this study. Potential risks associated with 
participation in this study include those that might reasonably be expected to occur in association with 
the underlying medical diagnosis, surgical procedure(s), and use of the proposed study device. The clinical 
investigation has been designed to involve as little pain, discomfort, fear and any other foreseeable risk 
as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined 
in the clinical investigation plan and constantly monitored. In the clinical study, the products will be used 
in accordance with the Surgical Technique and the IFUs that are available separate from this CIP. 
Reference is made to the IFUs for a detailed list of all risks and contra‐indications associated with the 
devices and surgery. Additional risks are those associated with radiation exposure for x‐rays beyond the 
standard of care for the purpose of study follow‐up. X‐rays will be taken prior to enrollment, during 
surgery and at each follow‐up visit. Females of childbearing age should be aware that radiation exposure 
may be harmful to an unborn fetus. 

Page 49 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Radiation doses may be potentially harmful, but the exact risks are difficult to measure. Subjects who are 
still concerned with the radiation exposure will be counseled that they may discuss this with their study 
doctor at any time. 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of a product, 
from the business analysis phase through development, market release, and post‐market surveillance. 
The risk analysis process for the BRAIVE IDE study was performed in accordance with ISO 14971 to ensure 
that the level of risk was acceptable prior to starting the study. 
 
10.2. Risk Minimization 
A comprehensive set of risk mitigation actions will be undertaken before, during and after the device 
implantation. 
 
10.2.1. Overall Mitigation Factors 
Overall study factors to mitigate risks include: 
• 
Investigator Selection 
Investigational sites will be selected based on experience and expertise in managing patients with 
JIS/AIS, ability to comply with the protocol and regulations, and clinical research expertise and 
resources. Only surgeons capable of performing the surgical procedure will be selected, which will 
mitigate the risks associated with the general surgery and with the treatment. Investigators 
selected to participate in this clinical study will be responsible for fulfilling the requirements of 
the investigator’s agreement and investigational plan. All investigators will sign an investigator 
agreement prior to initiation of screening or enrollment activities. 
Each investigator will be trained in all aspects of the protocol, including the surgical technique and 
completion of subject documentation. The Investigators will receive procedure and device specific 
educational tools, that will provide specific training on the targeted patient group and pathology. 
This training will assist the investigators with optimal patient selection and in all aspects regarding 
the pre‐operative planning and implantation of the device. 
Additionally, each investigator will be expected to make every effort to attend periodic 
Investigator’s Meetings or conference calls when requested (or send a representative, if 
unavailable) to assure familiarity and compliance with the study protocol. 
 
• 
Subject Selection 
Appropriate subjects will be carefully selected according to the specified inclusion and exclusion 
criteria, which will ensure that all the criteria from the approved intended use of the Braive GMS 
are met. 

Page 50 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
10.2.2. During Surgery 
• 
Risks of Braive™ GMS 
Investigators will be chosen based on relevant surgical experience and qualifications. Each 
investigator will be trained in all aspects of the protocol, including the surgical technique and 
completion of subject documentation. Furthermore, a minimally invasive, endoscopic approach 
with 20 mm skin incisions is used to implant the Braive GMS. This approach provides improved 
visualization of the spine, which reduces the risks associated with open surgery and eliminates 
the risk of a poor cosmetic result from a thoracotomy incision. Navigation and fluoroscopy 
alternatives are also available, thus further increasing the precision of the procedure and 
reducing the surgical risks. 
 
• 
Risks of Medtronic Reusable Instruments and Accessories (with/without  StealthStation) 
Investigators will be chosen based on relevant surgical experience and qualifications. Selection 
of appropriate patients, as well as knowledge and understanding of the surgical technique, are 
important considerations in the successful use of the instruments and accessories by the 
investigator. Thus, each investigator will be trained in the surgical technique. Additionally, the 
inclusion and exclusion criteria specified in the protocol ensure that appropriate patients are 
selected. 
 
10.2.3. During Post-operative Care 
Clinical and radiographic assessments including collection of Adverse Events, Reoperations and 
Revisions/Removals will be performed prior to hospital discharge (immediate post‐op), postoperatively at 
3 months, 6 months, 12 months, 18 months and 24 months and annually thereafter until the subject 
reaches skeletal maturity (defined as Risser 5 as assessed by investigator), and as reported, regardless of 
follow‐up interval. These assessments will mitigate the risks associated with the device including: 
• 
Overcorrection Risk 
The risk for overcorrection is the main risk with the anterior vertebral tethering procedure as 
many patients will experience a spine growth spurt after the device implantation. This growth 
spurt will render a faster spine deformity correction but also may increase the risk of 
overcorrection, which may require revision or removal. Therefore, follow up visits are scheduled 
at least every 6 months for the first 24 months following surgery and then annually until the 
subject reaches skeletal maturity (defined as Risser 5 as assessed by investigator). This provides 
the Investigators the opportunity to detect and treat curve corrections that may be approaching 
overcorrection. 
• 
Other Device and/or Procedure‐Related Risks 

Page 51 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Other reported risks with the procedure are implant loosening and implant failure, which may 
require revision or removal. The follow up visits that are scheduled until the subject reaches skeletal 
maturity ensure that these potential risks will be detected and can be treated before they have 
progressed. 
• 
Radiation Exposure Risk 
Subjects will be exposed to radiation from X‐rays taken during follow‐up visits. However, some 
of these X‐rays would likely be taken as standard of care for this condition, regardless of 
whether the patient was in the study. The ALARA (as low as reasonably possible) principles of 
reducing radiation exposure to the subjects enrolled will be recommended to all sites 
participating in the BRAIVE IDE study. 
 
10.2.4. Oversight of Safety 
The following oversight of safety mitigates the risk of device and/or procedure related adverse events 
being underreported or reported as either not related to the device and/or procedure or as nonserious. 
• 
Monitoring 
This study will be monitored according to a study specific monitoring plan. Therefore, it is 
expected that all adverse events will be captured and documented. 
• 
Safety representative 
All Adverse Events will be reviewed by Medtronic safety representative according to the Clinical 
Safety Management and Potential Complaint Plan. 
• 
Steering Committee and Medtronic Medical Advisor 
A steering committee and Medtronic medical advisor will monitor the safety of investigational 
treatment. 
 
10.2.5. Warning and Precautions 
The following Warnings and Precautions will mitigate the risks of subject selection, the surgical procedure 
and the Braive GMS device. 
A successful result is not always achieved in every surgical case. Spinal deformity may be unrelieved or 
worsened. There are general risks related to surgery, and specific risks related to the anterior procedure 
with the Braive™ GMS. These risks have been considered and mitigated as above. Careful patient 
selection, preoperative planning and surgical technique should be executed according to the training and 
education provided, and according to the study protocol and Instructions for Use. Unexpected events and 
variable patient biologic characteristics may still occur. 
Multiple factors contribute to the amount of curve correction including initial Cobb angle, growth 
potential remaining, and degree of intraoperative correction. Both under‐ and overcorrection are 

Page 52 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
possible, the latter being more prevalent in literature to date. Determining the amount of bone age 
remaining at the time of surgery and understanding general principles of growth modulation are critical 
to mitigating correction variables. Care should be taken to consider relevant patient parameters in 
preoperative planning and extent of intraoperative correction. Patients should be closely monitored 
postoperatively. 
Intervention may be necessary in the form of revision to cut, remove, or replace the braid or convert to 
fusion. An implanted device should never be re‐used. Implants are designed for single patient use only. 
Do not reuse, reprocess, or re‐sterilize used implants. Reuse, reprocessing, or re‐sterilization may 
compromise the structural integrity of these implants and create a risk of contamination of the implants 
which could result in patient injury, illness, or death 
 
10.3. Potential Benefits 
The primary benefits expected for the subjects treated with the Braive™ GMS include the prevention of 
curve progression and/or improvement of the curve, maintenance of spine flexibility with preservation of 
neurologic status, improved cosmesis and quality of life, and diminishing the need for spinal fusion surgery 
and its related potential risks. Advantages of the vertebral tethering technique compared to fusion include 
less blood loss, faster recovery time, spinal motion sparing, and less hardware placement resulting in 
decreased complications. Another cosmetic benefit due to the thoracic approach is the very small surgical 
incision below the armpit compared to the long incision along the spinal column for spinal fusion. 
 
Additionally, information collected from this study may assist in the modification of the existing system, 
the design of new product (s)/therapy(ies), and/or IFUs. 
 
10.4. Risk-Benefit Rationale 
Treatment of JIS and AIS patients via an anterior procedure with Braive™ GMS is expected to prevent the 
curve progression and/or improvement of the curve, to maintain a flexible spine into adulthood and to 
reduce the risk of fusion surgery later on in life. The treatment is also expected to result in improved 
subject spine cosmesis, improved self‐esteem, social activities status and improved quality of life. These 
subjects will have failed conservative treatment such as monitoring, physiotherapy and bracing, and are 
at risk of continued curve progression. Progression of the curve to the threshold where a spine fusion 
would be necessary, later in life, would be associated with increased morbidity risk, reduced quality of life 
and increased risk for re‐operation. Any risks associated with participation in this clinical study will be 
minimized and managed in accordance with and full compliance to 21 CFR Parts 50 (US only), 56, and 812 
(US only) and ISO14155:2020. The risks are minimized by selecting only qualified investigators 
experienced in the field of application and trained in the use of the study device(s) and qualified by 
education, training, and experience to assume responsibility for the proper conduct of the clinical 
investigation. In addition, this protocol outlines a follow‐up period designed to monitor the subjects until 

Page 53 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
skeletal maturity, with the majority of the visits taking place in the first 24 months to allow for the early 
detection of any adverse event. To reduce the risk of overcorrection, a subject’s remaining growth potential 
is limiting enrollment to subjects with a Sanders Score between 2 and 5. Additionally, the surgeon’s 
understanding of operative factors and the surgical technique reduce the risk of overcorrection. Prior to 
skeletal maturity, clinically significant overcorrection of the curve can be treated by removing the device, 
replacing and re‐positioning the device, or cutting the braid component to release tension, all of which will 
allow increased growth of the vertebrae on the operated side and may reduce the overcorrection. After 
skeletal maturity, clinically significant overcorrection of the curve can be treated by fusion surgery, which is the 
standard of care for skeletally mature patients that have failed bracing and were not treated with the AVBT. 
The potential sequelae for overcorrection are the same as those for scoliosis; however, the degree of 
overcorrection curvature is likely to be less than the degree of curvature at baseline. 
 
All the risks with the device have been deemed acceptable and the benefits of participating in the study 
outweigh the risks. 
 
 
11. Adverse Events and Device Deficiencies 
 
All AEs, DDs, and deaths, regardless of relatedness to surgical procedure or outcome, should be reported 
from the time the subject signs the informed consent form throughout the study in the eCRF and should 
be made available to the Medtronic study team. If applicable, these AEs and DDs will be reported to other 
countries where studies are conducted with the same or a similar product. 
 
11.1. Definitions/Classifications 
Investigator will classify each adverse event according to ISO 14155:2020. Adverse events and device 
deficiencies are defined as follows. Where the US and European terminology differs, the US term is listed 
first, followed by the European term. 
 
Table 7: AE Definitions/Classifications 
 
ISO Definitions for Clinical Investigations of Medical Devices for Human Subjects 
Adverse Event (AE): (ISO14155:2020 section 3.2) 
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or unanticipated 
NOTE 1: This definition includes events related to the investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 

Page 54 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
NOTE 3: For users or other persons, this definition is restricted to events related to investigational medical devices or 
comparators. 
Adverse Device Effect (ADE): (ISO14155:2020 section 3.1) 
Adverse event related to the use of an investigational medical device 
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the investigational medical 
device. 
NOTE 3: this includes ‘comparator’ if the comparator is a medical device. 
Device Deficiency (DD): (ISO14155:2020 section 3.19) 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 
performance. 
NOTE 1: Device deficiencies include malfunctions, use errors and inadequacy in the information supplied by the 
manufacturer including labeling. 
NOTE 2: This definition includes device deficiencies related to the investigational medical device or the 
comparator. 
SERIOUSNESS 
Serious Adverse Event (SAE): (ISO14155:2020 section 3.45) 
Adverse event that led to any of the following 
a) death, 
b) serious deterioration in the health of the subject, users or other persons as defined by one 
or more of the following: 
1) a life‐threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, including chronic 
disease, or 
3) in‐patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life‐threatening illness or injury or 
permanent impairment to a body structure or a body function, 
c) Fetal distress, fetal death or a congenital abnormality or birth defect including physical or 
mental impairment 
NOTE 1: Planned hospitalization for a pre‐existing condition, or a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse event. 
Serious Adverse Device Effect (SADE): (ISO14155:2020 section 3.44) 
Adverse device effect that has resulted in any of the consequences characteristic of a Serious Adverse 
Event. 

Page 55 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Unanticipated Adverse Device Effect (UADE): (21 CFR 812.3(s)) 
Any serious adverse effect on health or safety or any life‐threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death, was not previously identified in a nature, 
severity, or degree of incidence in the investigational plan or application (including a supplementary 
plan or application), or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects. 
Unanticipated Serious Adverse Device Effect (USADE): (ISO14155:2020 section 3.51) 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk assessment 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or outcome has 
been identified in the risk assessment. 
Serious Health Threat: (ISO14155:2020 section 3.46) 
Signal from any adverse event or device deficiency that indicates an imminent risk of death or a 
serious deterioration in the health in subjects, users or other persons, and that requires prompt 
remedial action for other subjects, users or other persons 
NOTE 1: This would include events that are of significant and unexpected nature such that they become alarming as a potential 
serious health hazard or possibility of multiple deaths occurring at short intervals. 
RELATEDNESS 
Relationship of 
Adverse Events 
Assessment of causality will be assessed for this study on the following basis: 
1. Not related: The relationship to the device or procedures can be excluded when: 
• 
The event is not a known side effect of the product category the device 
belongs to or of similar devices and procedures; 
• 
the event has no temporal relationship with the use of the 
investigational device or the procedures; 
• 
the event does not follow a known response pattern to the medical device 
(if the response pattern is previously known) and is biologically implausible; 
• 
the discontinuation of medical device application or the reduction of the 
level of activation/exposure when clinically feasible and reintroduction of 
its use (or increase of the level of activation/exposure), do not impact on 
the serious event; 
• 
the event involves a body site or an organ not expected to be 
affected by the device or procedure; 
• 
the event can be attributed to another cause (e.g., an underlying or 
concurrent illness/ clinical condition, an effect of another device, drug, 
treatment or other risk factors); 
• 
the event does not depend on a false result given by the 
investigational device used for diagnosis, when applicable; 
• 
harms to the subject are not clearly due to use error. 
To establish the non‐relatedness, not all the criteria listed above might be met at 

Page 56 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
the same time, depending on the type of device/procedures and the serious event. 
2. Unlikely: The relationship with the use of the device seems not relevant and/or 
the event can be reasonably explained by another cause, but additional 
information may be obtained. 
3. Possible: The relationship with the device is weak but cannot be ruled out 
completely; alternative causes are also possible (e.g., an underlying or concurrent 
illness/ clinical condition or/and an effect of another device, drug or treatment). 
Cases where relatedness cannot be assessed, or no information has been obtained 
should also be classified as possible. 
4. Probable: The relationship with the use of the device seems relevant and/or 
the event cannot reasonably be explained by another cause, but additional 
information may be obtained. 
5. Causal relationship: the event is associated with the investigational device or 
procedures beyond reasonable doubt when: 
• 
the event is a known side effect of the product category the device belongs 
to or of similar devices and procedures; 
• 
the event has a temporal relationship with the investigational device 
use/application or procedures; 
• 
the event involves a body‐site or organ that 
o 
the investigational device or procedures are applied to; 
o 
the investigational device or procedures have an effect on; 
• 
the event follows a known response pattern to the medical device (if the 
response pattern is previously known); 
• 
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the event (when clinically feasible); 
• 
other possible causes (e.g., an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or treatment) have 
been adequately ruled out; 
• 
harm to the subject is due to error in use; 
• 
the event depends on a false result given by the investigational device 
used for diagnosis, when applicable; 
 
To establish the relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device /procedures and the serious event. 
SEVERITY 
Mild (Grade 1): Asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
Moderate (Grade 2): Minimal, local or noninvasive intervention indicated; limited age appropriate 
instrumental activities of daily living (preparing meals, shopping, using the phone, managing 

Page 57 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
money, etc.). 
Severe (Grade 3): Severe or medically significant but not immediately life‐threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting age appropriate 
self‐care activities of daily living (bathing, dressing and undressing, feeding self, toileting, taking 
medications, and not bedridden). 
Life Threatening (Grade 4): Life threatening consequences; urgent intervention indicated; death. 
SUBSEQUENT SPINAL SURGICAL INTERVENTION 
Subsequent spinal surgical interventions will be classified using the following definitions, based on the 
description provided: 
• 
Revision is a procedure that adjusts, or in any way modifies or removes, part of the original 
implant configuration, with or without replacement of a component. A revision may 
also include adjusting the position of the original implant configuration. 
Revisions will be considered in two categories: 
o Preventive surgery: Any braid manipulations (e.g., cutting or loosening the braid). 
Preventive surgery for overcorrection will not be considered a treatment failure 
o Non‐preventive surgery: The revision is the result of an adverse event, i.e., the initial 
positioning of the device contributed to the adverse event and must be repositioned, 
or additional instrumentation is added to the original implant configuration. Non-
preventive surgery will be considered as a treatment failure. 
• 
Removal is a procedure where all of the original system configuration is removed with or 
without replacement. Removal surgery will be considered a treatment failure. 
• 
Reoperation is a surgical procedure at the study treatment level(s) that does not involve 
removal, modification, or addition of any components to the original system. Examples include 
debridement of a surgical wound, scar revision or evacuation of a hematoma. These will not be 
considered a treatment failure. Spinal fusion or extension of the fixation due to the progression 
of initial scoliosis will be considered a treatment failure. 
• 
Other is any other subsequent spinal surgical procedure not classified as a revision, removal or 
reoperation. Examples include spinal surgery not at the study treatment level(s) such as 
microdiscectomy or hernia repair. 
 
 
 
11.2. Reporting of Adverse Events 
All Adverse Events (except unavoidable events listed in Section 11.3), regardless of relatedness or 
outcome, must be reported. The investigator is responsible for reporting all AEs to Medtronic and for their 
follow up. 
 
Pain, neurological, and function symptoms should be reported as an adverse event when a subject’s 

Page 58 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
complaint for any of these symptoms results in an unscheduled visit or when a subject presents with 
clinically significant new or worsening pain, neurological and/or function symptoms as compared to the 
previous visit. 
All adverse events will be classified using the following responsibility matrix: 
 
Table 8. Adverse Event Classification Responsibilities 
What is classified? 
Who classifies? 
Classification Parameters 
Relatedness 
Investigator 
Device, Procedure 
Sponsor 
Device, Procedure 
Seriousness 
Investigator 
SAE, DD with SADE potential 
Sponsor 
SAE, DD with SADE potential 
Severity 
Investigator 
Mild, Moderate, Severe, Life Threatening 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and other supporting data 
Sponsor 
MedDRA term assigned based on the data provided by Investigator 
Expectedness 
Sponsor 
UADE/USADE 
 
From the time that the assent/informed consent forms are signed, all reportable events must be recorded 
in the subject’s medical record and on the Adverse Event and/or Device Deficiency eCRF and promptly 
reported to Medtronic. IRB/EC/REB reporting must be completed in accordance with the policies of the 
governing IRB/EC/REB. Regulatory Authority reporting should be in accordance with applicable local 
regulations. 
It is the responsibility of the investigator to identify the occurrence of adverse events and device 
deficiencies and to ensure the required information is accurately documented on the eCRF. 
Reports of adverse events and device deficiencies will include the following information, at a minimum: 
• 
Date of event 
• 
Date site became aware of the event 
• 
Diagnosis or description of the event 
• 
Assessment of the seriousness and relationship to the device and/or surgical procedure 
• 
Treatment provided 

Page 59 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Outcome and date of resolution 
The clinical course of each adverse event must be followed until resolution, subject discontinuation from 
the study or last study follow up visit, whichever comes first. “Not resolved” adverse events and device 
deficiencies must be assessed at each protocol required visit, and new or updated information must be 
documented on the Adverse Event and/or Device Deficiency eCRF and promptly reported to Medtronic 
and where applicable to the IRB/EC/REB. At time of study exit, the status of all unresolved Adverse Events 
should be evaluated and should reflect the subject's status at time of study exit. 
Upon request of Medtronic, de‐identified source documentation should be provided to Medtronic. When 
printouts of original electronic source documents are obtained, these shall be signed and dated by a 
member of the investigator site team with a statement that this is a true reproduction of the original 
source document. 
Upon request of Medtronic, de-identified images should be provided to Medtronic. 
 
Medtronic study personnel will promptly review all reported adverse events and device deficiencies and 
if necessary, request clarification and/or additional information from the investigator. If Medtronic 
disagrees with the Investigator’s assessment of the adverse event seriousness and relationship to the 
device and/or procedure, Medtronic study personnel will document the disagreement and report or 
ensure reporting of both opinions to the IRB/EC and regulatory authority as necessary. In addition, 
aggregate safety data will be reviewed and analyzed to identify potential safety issues, signals, and trends 
at minimum, annually. 
 
Investigators must report applicable events and product deficiencies to Medtronic and where 
appropriate, to an IRB/EC/REB or regulatory authority. Details (e.g., date of event, treatment, resolution, 
seriousness, relationship to the product) of the events and product deficiencies must be documented in 
the medical record and reported to Medtronic per Table 10. 
 
11.3.  Not reportable events 
Examples of events that are not reportable as adverse events for this study are: 
• 
A documented pre‐existing condition unless there is a worsening of the nature, severity, duration, 
or frequency of that condition. 
• 
Elective or Preventative medical procedures (e.g., tooth extraction, cosmetic surgery); however, 
the condition leading to the procedures might be a reportable event if there is a worsening of the 
nature, severity, duration, or frequency of that condition. 
Table 9 provides a list of Unavoidable Adverse Events (UAE). An UAE will not be considered reportable 
unless it worsens or is present outside the stated timeframe post‐procedure. 
 
 

Page 60 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
Table 9. Unavoidable Adverse Events (UAEs) 
 
Event Description 
Timeframe from the Surgical Procedure 
Anesthesia related nausea / vomiting 
24 hours 
Low‐grade fever (<100°F or 37.8°C) 
48 hours 
Mild to moderate bruising / ecchymosis 
7 days 
Seroma 
72 hours 
Sleep problems (insomnia) 
72 hours 
Back pain related to laying on the table 
72 hours 
Shoulder pain/discomfort/stiffness 
72 hours 
Pneumothorax, non-serious 
72 hours 
Supplemental Oxygen with no other 
24 hours 
Blood loss less than 800 cc 
24 hours 
 
11.4. Device Deficiencies 
A device deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and 
inadequate labeling. All device deficiencies must be documented and submitted to Medtronic on the 
Device Deficiency eCRF. In addition, the investigator must also determine and document on the eCRF 
device deficiencies that did not lead to adverse event but could have led to a serious adverse device effect: 
• 
If either suitable action had not been taken, 
• 
If intervention had not been made, or 
• 
If circumstances had been less fortunate 
• 
Refer to Table 10 for investigator reporting timelines for device deficiencies. 
 
11.5. Reporting Adverse Events to Medtronic 
Investigator reporting timelines can be found in Table 10. The preferred way of transmission of AEs and 
DDs is the RDC system, but in case the eCRF cannot be accessed, the investigator should contact study 
personnel by e‐mail to report. The AE/DD worksheet provided to investigators may be used for completion 
of available information, preferably signed by investigators and attached to the email. The same CIP 
reporting timelines apply for all types of reporting as if the eCRF would be available. 
 
 
 

Page 61 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
Table 10. Required timeframes for Adverse Advent Reporting by Investigator 
 
Required Timeframes for Adverse Event reporting from Investigator to Medtronic 
Event Type 
Timeframe for Reporting 
Serious Adverse Event (SAE) 
Immediately (but no later than 3 calendar days) after the 
investigator first learns of the event or of new information in 
relation with an already reported event. 
Serious Adverse Device Effect 
(SADE) 
Unanticipated Adverse Device 
Effect (UADE) 
Unanticipated Serious Adverse Device 
Effect (USADE) 
Device Deficiencies with SADE 
potential 
All Other Adverse Event (AE) 
In a timely manner after the investigator first learns of the event 
All other Device Deficiencies 
Required Timeframe for Adverse Event reporting from Investigator to Health Canada (for 
Canadian sites only) 
Serious Adverse Device Effect 
(SADE) 
In Canada, SADEs on the subject, the user or any other person must 
be reported to Health Canada and to the sponsor within 72 hours 
after it comes to the attention of the qualified investigator. 
Unanticipated Adverse Device 
Effect (UADE) 
In Canada, UADEs on the subject, the user or any other person must 
be reported to Health Canada and to the sponsor within 72 hours 
after it comes to the attention of the qualified investigator. 
Unanticipated Serious Adverse Device 
Effect (USADE) 
In Canada, USADEs on the subject, the user or any other person must 
be reported to Health Canada and to the sponsor within 72 hours 
after it comes to the attention of the qualified investigator. 
Device Deficiencies with SADE potential 
In Canada, DDs that have resulted in any of the consequences 
characteristic of an SAE on the subject, the user or any other person 
or could do so were it to reoccur must be reported to the regulator 
and the Sponsor within 72 hours after it comes to the attention of 
the qualified investigator. 
 
The AE reporting period for each subject starts when the subject and/or parent/legal guardian signs the 
Informed Consent/Assent and continues at all subsequent visits through the end‐of‐study. Any pre‐ 
existing conditions that are detected as part of the screening procedures should be reported on the 

Page 62 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
prior medical history form and not as AEs. However, pre‐existing conditions that worsen during the 
study will need to be reported as AEs. 
If possible, a specific diagnosis should be recorded, rather than a listing of individual signs and symptoms. 
In addition, investigators are obligated to report adverse events in accordance with the requirements of 
their reviewing IRB/EC/REB and regulatory authority (where applicable). The Sponsor is obligated to report 
AEs that occur during this trial to the Regulatory Authorities and IRB in compliance with applicable local 
requirements. 
Any necessary follow‐up reports should be completed by updating the original AE eCRF in a timely 
manner. All follow‐up reports should give full details of the event, including an updated assessment of 
the relationship to the procedure and/or device. When contacting the sponsor regarding SAEs/UADEs, 
site personnel should be prepared to provide as much information as is available at the time. 
 
Detailed sponsor contact information including emergency contact details will be provided under a 
separate cover. 
 
11.6. Pregnancy Reporting 
Pregnancy itself is not considered to be an adverse event; however, it is a study deviation if the subject 
becomes pregnant within 24 months postoperatively. If the subject experiences untoward medical 
occurrences during pregnancy or at delivery, these should be recorded as an adverse event and reported 
to the sponsor immediately after becoming aware of the event. Female subjects who become pregnant 
during the study will be followed until the completion of the study. If available, outcomes will be collected 
on both mother and child. 
 
11.7. Deaths 
All subject deaths must be reported to Medtronic and the IRB/EC/REB as soon as possible (but no later 
than 3 calendar days), after learning of a subject’s death, regardless of whether or not the death is related 
to the device system and/or procedure. The investigator should also attempt to determine, as conclusively 
as possible, whether such deaths are related to the device system and/or procedure. If the death is 
evaluated as device and/or procedure related and unanticipated, the event will be reported as a 
UADE/USADE by Medtronic or its designee to the appropriate Regulatory Authorities. 
Any subject death will be reported on the Adverse Event and Study Exit eCRFs. If limited information is 
known, the Adverse Event eCRF must be completed with available information as soon as possible. The 
cause of death will be reported on the Adverse Event and death will be reported on the Study Exit eCRFs. 
 
 
12. Data Review Committees 

Page 63 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
12.1. Data Monitoring Committee 
Ongoing oversight for this study was provided by an independent DMC (Data Monitoring Committee) until 
enrollment was stopped. Considering enrolment stop and the changes in study design the decision was 
made to close the DMC and institute a periodic data review by   a steering committee and Medtronic 
medical advisor to monitor the safety of the investigational treatment. The BRAIVE IDE Clinical Study 
steering committee is a group of at least 3 scientific or subject matter experts which includes pediatric 
orthopedic surgeons and neurosurgeons and physicians involved in juvenile and adolescent scoliosis.   A 
chairperson from among those members will be identified and the steering committee will operate 
according to a charter. A review of the FDA annual report and event rate of the study will be made at least 
annually by steering committee, active investigators and Medtronic medical advisor. 
 
12.2. CRO / Core labs 
The information below maybe subject to change during the course of the study. Periodic updates to study 
contact information will be sent to study sites as need.  
 
Table 11. CRO and Core Laboratory Information 
Contact Information 
Role 
Medical Metrics, Inc 
2121 Sage Road, Suite 300 
Houston, TX 77056 
USA 
Radiographic analysis lab & Image Transfer of 
intraoperative images 
Used for eligibility assessment of currently enrolled 
subjects 
 
 
13. Statistical Design and Methods 
 
 
The initial plan was to conduct the primary analysis when all subjects have reached the 2‐year visit and an 
updated analysis when all subjects have reached skeletal maturity. Due to the decision to stop study 
enrollment, a final analysis will be conducted when all subjects have reached skeletal maturity.  An interim 
analysis may be conducted when all subjects reach 24-month visit in addition to the progressive report 
requested by FDA. . 
 
13.1. Analysis of Baseline Data 
Baseline and pre‐operative data will include but are not limited to height, weight, age, and preoperative 
clinical and radiographic measurements. Demographics and other pre‐treatment characteristics will be 
summarized and characterized with appropriate descriptive statistics. Categorical variables will be 

Page 64 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
summarized using frequency and percentage. Continuous variables will be summarized using mean, 
median standard deviation, minimum, and maximum. 
 
13.2. Sample Size 
This initial study was designed to show that the investigational device can be used to obtain a statistically 
significant improvement (>0) in the main thoracic Cobb angle. The initial sample size required to 
demonstrate a statistically significant improvement of Cobb angle at 24 months as compared to that in 
the preoperative visit is 24. Medtronic planned to treat 25 subjects. Due to the decision to stop enrollment 
early, the sample size is 10 at the time of enrollment stop.  
 
13.3. Primary Analysis Population 
The primary analysis population will include all subjects who are enrolled and undergo the Braive™ GMS 
surgical procedure. The primary dataset will be used for all the analyses. For subjects who are treatment 
failures, the last postoperative observation before the first treatment failure will be carried forward for 
all additional secondary endpoints and neurological status. No imputation for missing data will be made 
for other subjects. 
 
 
13.4. Analyses for Additional Secondary Endpoints 
 
All additional secondary endpoints are listed in the section 5.2.3. For the additional secondary endpoints 
related to the change from the baseline (pre-op or post-op baseline for instrumented Cobb angle), when 
the distribution of data is approximately normally distributed, the changes from baseline will be tested 
using a paired‐sample t‐test. When the distribution of the data is severely non‐normal, a Wilcoxon signed‐
rank test may be used in place of the paired t‐test. In addition, the descriptive statistics including but not 
limited to mean, standard deviation, median, minimum and maximum will be calculated and presented. 
For “Status of return to full activity within 3 months per SRS‐22”, the number and percentage of subjects 
returned to full activity within 3 months will be calculated and presented.  
Additional analysis will be performed by comparing the postoperative measurements at follow up visits 
with the measurements at immediate post-op. 
 
13.5. Missing Data Considerations 
All analyses will be conducted based on the observed data with no missing data imputation.  
 
13.6. Safety Analysis 
 

Page 65 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
13.6.1. Primary Safety Endpoint 
The primary safety endpoint is device-related adverse events up to 24-month visit postoperatively. 
The number of events, the number and percentage of subjects experiencing device related AE up to 24 
months postoperatively will be presented. 
In addition, all device-related adverse events up to skeletal maturity (Risser 5) will be summarized. 
 
13.6.2. Secondary Safety Endpoint 
The secondary safety endpoints include: 
 
• 
Procedure‐related adverse events up to 24 months 
• 
Secondary spinal surgeries related to the original study device up to 24 months. 
• 
Device deficiency up to 24 months 
 
In addition, all procedure-related and device related adverse events up to skeletal maturity, all secondary 
surgeries related to the original study device up to skeletal maturity and device deficiency up to skeletal 
maturity will be summarized. 
 
13.6.3. Adverse events 
A listing of all AEs will be provided, and a narrative of each device or procedure related AEs, secondary 
spinal surgeries, and death will be generated. In addition, summaries of AEs, both overall and by visit, will 
be provided. 
 
Summaries will be presented for all AEs, SAEs, device or procedure‐related AEs and device or procedure‐ 
related SAEs. Time course distributions will be provided in addition to cumulative summaries. Time course 
distributions will be based on the surgery date of the subject and onset dates of AEs, based on continuous time 
intervals. For overall AE summaries, a subject reporting the outcome at least once during the study period 
will be included in the frequency count. The percentage of subjects reporting the event at least once 
during the study period will be reported, and the denominator used in this calculation will be the total 
number of subjects who are enrolled and who receive the study treatment. 
For AE summaries by visit, a subject reporting the outcome at least once during each visit window will be 
included in the frequency count. The percentage of subjects reporting the outcome at least once during 
each visit window will be reported, and the denominator used in this calculation will be the number of 
subjects who have any data reported at that visit (clinical or safety). 
 
13.6.4. Neurological status 
The number and percentage of subjects with normal and abnormal neurological status for each 

Page 66 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
component and overall at pre-op and discharge, and number and percentage of subjects with “improved”, 
“maintained” and “deteriorated” neurological status from pre‐op to post‐op for each component and with 
“success” and “failure” for overall neurological status will be summarized. 
 
13.6.5. Subsequent Spinal Surgical Interventions 
Subsequent spinal surgical interventions including those that are related to the original study device or 
not related will be summarized in a similar way as for AEs. The summary will list different types of 
subsequent spinal surgical interventions. The numbers of events and subjects who undergo subsequent 
spinal surgical interventions and the associated time course distribution will be presented. 
 
14. Ethics 
 
14.1. Statement of Compliance 
• 
The study will be conducted according to the protocol, ISO14155:2020, federal, national and local 
laws, regulations, standards, and requirements of the countries/geographies where the study is 
being conducted. The study will also be conducted in accordance with ethical principles that have 
their origin in the Declaration of Helsinki 2013. The principles of the Declaration of Helsinki are 
implemented in this study by means of the Subject Informed Consent (IC) process, IRB/EC/REB 
approval, study training, clinical trial registration, pre‐clinical testing, risk benefit assessment, and 
publication policy. 
• 
In the US, the study will be conducted under an FDA Investigational Device Exemption (IDE) in 
compliance with 21 CFR Parts 11, 50, 54 and 812. In Canada and Europe, the study will be 
conducted in compliance with 21 CFR Part 11 and 54 and any national/local laws or regulations 
that apply. Study Investigators will be required to sign an Investigator Statement stating their 
intent to adhere to applicable regulations. Regulatory authority notification/approval to conduct 
the trial is required in all participating geographies, when applicable. Clinical sites will not begin 
enrolling subjects until the required approval/favorable opinion from the respective regulatory 
authority and IRB/EC/REB has been obtained (as appropriate). 
• 
If any action is taken by an IRB with respect to the investigation, the information will be forwarded 
to the sponsor. 
• 
This study will be publicly registered prior to first enrollment in accordance with the 2007 Food 
and Drug Administration Amendments Act (FDAAA) and Declaration of Helsinki on 
http://clinicaltrials.gov (PL 110‐85, Section 810(a)). 
The clinical investigation shall not begin at any site until the required approval/favorable opinion from the 
US Food and Drug Administration (FDA) or other appropriate regulatory authority, the IRB/EC/REB has 
been obtained, if appropriate. 
Any additional requirements imposed by the IRB/EC/REB or regulatory authorities shall be followed, if 
appropriate. 

Page 67 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
14.2. Institutional Review Board (IRB) / Ethics Committee (EC) / 
Research Ethics Board (REB) 
This study will be conducted in full compliance with the IRB/EC/REB regulations. It is the investigator's 
obligation to maintain an IRB/EC/REB correspondence file and to make this file available for review by the 
sponsor's representatives as part of the study monitoring process. 
 
14.3. Principal Investigator Obligation 
Each site will have a Principal Investigator (PI). The PI has overall responsibility for the day‐to‐day 
conduct of the trial at the site and for the integrity of the trial data generated by their site. 
Specifically, the PI is responsible for the following: 
• 
Protecting the rights, safety, and welfare of the subjects in their care 
• 
Obtaining written informed consent/assent of all subjects prior to any trial‐related procedures, and 
only after Ethics Committee and regulatory approval (where applicable) of the trial 
• 
Obtaining and maintaining Ethics Committee approval 
• 
Conducting the investigation in accordance with the signed agreement, CIP, applicable laws and 
regulations, and any conditions of approval imposed by an Ethics Committee or regulatory authorities 
• 
Providing accurate financial disclosure to the sponsor, including any relevant changes during the 
course of the trial and for 1 year after the completion of the trial 
• 
Reporting adverse events and device deficiencies in accordance with the CIP and according to country 
regulations (excluding European sites: sponsor is responsible for reporting AEs and DDs to EC and 
Competent Authority) 
• 
Approving all case report forms (or authorizing a sub‐investigator to do so); approval of the case 
report form indicates the data represented are accurate and have been reviewed 
• 
Maintaining accurate, complete, and current records, including: 
• 
All correspondence with another investigator, the sponsor, the monitor, the Ethics Committee 
(including required reports), or regulatory agency 
• 
Records of each consented subject’s case history, signed and dated informed consent(s)/Assent(s), 
exposure to the device, eCRFs, and source documents 
• 
The CIP, and documentation of dates of and reasons for each protocol deviation 
• 
Any records required by a regulatory agency 
• 
Ensuring that clinical records are clearly marked to indicate that the subject is enrolled in the study 
• 
Allowing time with the trial monitor and Sponsor trial staff members during Sponsor site visits 
• 
Informing the sponsor if any action is taken by an Ethics Committee or regulatory authority 
• 
Failure to perform the investigator obligations or to complete corrective and preventive actions 
identified during monitoring or auditing activities may result in Principal Investigator or site 
personnel disqualification, and/or lead to suspension or termination of the study at the site. 
 
14.4. Oversight of Study Personnel 

Page 68 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
The Principal Investigator may delegate study‐related tasks to appropriately trained and qualified personnel 
to ensure alignment between contractual obligations and delegated study responsibilities. 
The delegation of study‐related tasks will be documented on the Delegation of Authority Log and the 
Principal Investigator will provide ongoing oversight of all delegated study‐related tasks. 
The Principal Investigator will ensure training is provided, completed and documented for all staff 
performing delegated study‐specific tasks. 
Study center personnel participating in the clinical study will be trained in study activities relevant to their 
role. Training must be completed and documented prior to that individual conducting any study related 
activities. 
Investigator and/or study coordinator meeting(s) or telephone conference call(s) may be held to discuss 
the CIP, training, study results, etc. Continued training may occur through interim meetings or telephone 
conference calls to discuss relevant study issues. 
 
14.5. Medtronic Representative Role 
Medtronic representatives may provide support as required for the study under the direct supervision of 
the investigator as described below. The Principal Investigator or a person designated on the Delegation 
of Authority Log must be present to collect source documentation, record the study activities, and to be 
responsive to the subject’s needs during an activity performed by a Medtronic representative. 
Medtronic personnel may: 
• 
Provide technical support during the procedure and follow‐up visits 
• 
This support may include the training of site personnel on the use of the Medtronic equipment or CIP‐
related procedures and data collection 
• 
Clarify device behavior, operation, or diagnostic output as requested by the Principal Investigator or 
other health care professional 
• 
Assist with the collection of device and technical data during the procedure (technical worksheets) 
• 
Assist with collecting image data from the StealthStation and O‐arm 
• 
Assist with device and tissue explant retrieval (e.g., labeling the ruler, bags and containers, taking 
photographs of retrieved implant components and tissue) 
Medtronic personnel may not: 
• 
Practice medicine, provide medical diagnoses or make decisions related to subject treatment/care 
• 
Express opinions about the product/feature under study 
• 
Assist the subject by direct physical contact except as required by the specific protocol‐related 
task to be conducted 
• 
Discuss a subject’s condition or medical treatment with the subject or a member of the subjects’ 
family 
• 
Provide the subject with any form/questionnaires related to the product(s) under investigation 
• 
Enter data on eCRFs, except on the Medtronic Use Only Field 

Page 69 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
Any data collection completed by Medtronic personnel will be clearly identified as such. 
 
15. Study Administration 
 
15.1. Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train site personnel on the CIP, 
relevant standards and regulations, informed consent process, and on data collection and reporting tools. 
If new members join the investigation site team afterwards, they will receive training on the applicable 
clinical study requirements relevant to their role before contributing to the clinical study. 
Prior to performing study related activities, all local regulatory requirements shall be fulfilled, including, 
but not limited to the following: 
• 
IRB, EC or REB approval (and voting list, as required by local law) of the current version of 
the CIP and Informed Consent/Assent (as applicable). 
o US IRBs will maintain compliance with 21 CFR 50, 56 and 45 CFR Part 46 and/or 
appropriate local law. 
 
o It is the investigator's obligation to maintain an IRB/EC/REB correspondence file 
and to make this file available for review by the sponsor's representatives as part 
of the study monitoring process. 
 
• 
Regulatory authority approval or notification (as required per local law) 
• 
Fully executed Clinical Trial Agreement (CTA) ‐ Medtronic contracts with participating 
institutions/investigators through a Clinical Trial Agreement that defines the scope and 
responsibilities and associated compensation related to carrying out the obligations under a 
clinical study sponsored by Medtronic. 
• 
Financial Disclosure 
• 
Curriculum Vitae of investigators and key members of the investigation site team (as required 
by local law) 
• 
Documentation of delegated tasks 
• 
Documentation of study training 
Medtronic will provide each study center with documentation of investigation site/investigator readiness; 
this letter must be received prior to subject enrollment. 
 
15.2. Monitoring 
Monitoring visits will be conducted onsite or remotely at the start, during and at the closure of the clinical 

Page 70 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
study in accordance with Medtronic SOPs and the Monitoring Plan. The sponsor will adhere to the 
monitoring plan which contains the strategy for frequency of monitoring visits and source data verification 
to be performed for this study. Medtronic is responsible for ensuring the proper conduct of this study in 
terms of adherence to applicable regulations, protocol compliance, and the validity and accuracy of the 
study data entered on eCRFs. The Principal Investigator and site personnel will provide the Medtronic 
monitor(s) with complete access to primary source data (e.g., paper and electronic hospital/clinical charts, 
appointment books, laboratory records) that support the data on the eCRFs as well as other 
documentation supporting the conduct of the study. Procedures for monitoring subject compliance will 
be documented in the monitoring plan. 
During the site evaluation or Site Qualification process, Medtronic or Medtronic representatives will 
review the protocol and regulatory requirements with the investigator and/or clinical site personnel and 
will assess if the site meets pre‐defined requirements, has the experience, the time and resources to 
conduct the study. 
Site Initiation Visits will be conducted for sites participating in this trial for training to ensure that 
protocol‐related activities will be conducted in compliance with this CIP. 
Medtronic will provide clinical study training on the CIP, Informed Consent process, data collection tools, 
and regulations to the involvement of personnel conducting clinical study activities and investigator 
responsibilities. 
During an Interim Monitoring Visit, the monitor will perform source data verification by review of original 
subject documents. To do this, the monitor must have direct access to original source documentation, 
certified copies of the original source must be provided, or supervised access in situations where direct 
access is not possible. It will be verified whether signed and dated Informed Consent/Assent Forms have 
been obtained from subjects and/or parent(s)/legal guardian before any clinical‐study‐related procedures 
are undertaken. In addition, the monitor will perform routine reviews of study‐related regulatory 
documents and work to secure compliance should any deficiencies be observed 
Close Out Visits: The Investigator Site File will be reviewed for completeness; however, verification of 
individual regulatory documents may also be confirmed if noted in prior monitoring visits reports and do 
not necessarily need to be re‐reviewed during the Close‐out Visit. 
 
15.3. Data Management 
Medtronic personnel will perform routine edit and consistency checks for items such as missing data or 
inconsistent data. Identified data inconsistencies will be resolved by use of data discrepancies; 
investigators and site personnel will review data discrepancies and respond to the discrepancies in a 
timely manner. The resolved discrepancy will become a part of the eCRF record for the subject. 
The RDC system which is 21 CFR part 11 compliant controls user access and ensures data integrity. This 
system is a fully validated system. The RDC system maintains an audit trail of entries, changes or 

Page 71 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
corrections in eCRFs. User access will be granted to each individual based on his or her delegation of 
authority and completion of required training. If a person only authorized to complete eCRFs makes 
changes to an already signed eCRF, the system will require the Principal Investigator, or authorized sub‐ 
investigators, to re‐sign the eCRF. 
The Principal Investigator, or designated sub‐investigators, is responsible for the data submitted and must 
review all data for accuracy and provide his/her approval of the eCRF and sign each form with an electronic 
signature. 
 
15.4. Direct Access to Source Data/Documents 
The investigator(s)/institution(s) will permit study‐related monitoring, audits, IRB/EC/REB review, and 
regulatory inspection(s), providing direct access to original or certified copies of source data/documents. 
Medtronic or third‐party auditors representing Medtronic may perform Quality Assurance audits to verify 
the performance of the monitoring process and study conduct, and to ensure compliance with applicable 
regulations. Representatives for regulatory bodies may also perform site inspections related to this clinical 
study. The Principal Investigator, site personnel, and institution will provide auditors with direct access to 
primary source data and all study‐related documentation. 
Medtronic will investigate, and report suspected cases of fraud or misconduct as appropriate. 
 
15.5. Confidentiality 
All information and data sent to parties involved in study conduct concerning subjects or their 
participation in this study will be considered confidential. Study sites will assign a unique SID to each 
subject. Records of the subject/SID relationship will be maintained by the study site. The SID number is to 
be recorded on all study documents to link them to the subject’s medical records at the study site. 
Confidentiality of data will be observed by all parties involved at all times throughout the clinical 
investigation. All data shall be secured against unauthorized access. The privacy of each subject and 
confidentiality of his/her information shall be preserved in reports and when publishing any data. In the 
US, “Protected Health Information” (PHI) will be maintained in compliance with the HIPAA of 1996. To 
maintain confidentiality, the subject’s name or any other PHI should not be recorded on any study 
document other than the IC. This scenario will be covered in the IC. In the event a subject’s name/PHI is 
included for any reason, it will be blinded as applicable. In the event of inability to blind the identification 
(e.g., digital media), it will be handled in a confidential manner by the authorized personnel. Data relating 
to the study might be made available to third parties (for example in case of an audit performed by RA), 
provided the data are treated as confidential and that the subject’s privacy is guaranteed. No identifiable 
subject information will be published. 
 

Page 72 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
15.6. Liability 
 
15.6.1. Financing and Insurance 
Medtronic maintains appropriate clinical study liability insurance coverage as required under applicable 
laws and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a Clinical Trial insurance statement/certificate will be provided to the IRB/EC/REB 
and the Regulatory Authorities. 
 
15.6.2. Center for Medicare and Medicaid Services (CMS) IDE Study Criteria 
Medicare beneficiaries most likely will not be affected by the investigational device because the 
indications for the study are for the treatment of juvenile or adolescent idiopathic scoliosis. The study 
results are expected to be within the adolescent population. Adolescents covered by Medicaid may be 
included in the trial if they meet the indications. 
 
15.7. CIP Amendments 
Protocol amendments may be initiated by Medtronic to address changes to the conduct of the study. 
Protocol amendments must be approved by Medtronic and submitted to the IRBs/ECs and the governing 
regulatory authority (where required); protocol amendment approval and approval of any associated 
changes to the informed consent/assent document must be obtained prior to implementation of the 
amendment except: 
• 
When necessary to eliminate an immediate/or apparent immediate hazard to participating 
subjects 
 
15.8. Record Retention 
All study‐related documents must be retained for a period of at least 2 years after market‐release in 
his/her region and after study closure (or longer if required by local law). Medtronic will inform the 
investigator/study site when these documents are no longer required to be retained. 
No study document or image will be destroyed without prior written agreement between Medtronic and 
the investigator. The investigator should take measures to prevent accidental or premature destruction 
of documents. Should the investigator wish to assign the study records to another party or move them to 
another location, advance written notice must be given to Medtronic. 
Medtronic will retain the study records according to Medtronic corporate policy and record retention 
schedule. 
 

Page 73 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
15.9. Publication and Use of Information 
At a minimum, study data will be analyzed and results will be released on www.clinicaltrials.gov. 
Due to limited data availability, there is no intent to publish the available study results in a peer-reviewed 
journal.  
Only with Medtronic’s explicit and written permission, may investigators who gathered data for this study 
(i.e., enrolled subjects and complied with the protocol) write or contribute to the writing of abstracts and 
manuscripts based on the results of this study. 
Before publication of any study‐related data, the following guidelines will apply: 
• 
Investigators are obligated to provide Medtronic with an opportunity to review any 
publication developed from data derived from this study. 
• 
Medtronic will not financially compensate health care professionals (HCPs) or health care 
organizations (HCOs) for writing or editing activities on scientific publications related to 
research sponsored by Medtronic. 
 
15.10. Suspension or Early Termination 
 
15.10.1. Planned Study Closure 
Study closure is defined as closure of a clinical study that occurs when Medtronic and/or regulatory 
requirements have been satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or 
regulatory authority, whichever occurs first. In all geographies, the study closure process is complete upon 
distribution of the Final Report or after final payments, whichever occurs last. For each center, Ethics 
Board approval renewals are required per local/country regulation until the study closure process is 
complete at that center. 
 
15.10.2. Early Termination or Suspension 
Medtronic reserves the right to suspend or terminate the study at any time. Reasons may include, but are 
not limited to, the following: 
• 
Insufficient enrollment to complete the study within the expected timeframe 
• 
Identification of unacceptable safety profile; suspicion of an unacceptable risk will result in a 
suspension, confirmation of an unacceptable risk will result in termination 
• 
If a death occurs attributable to the Braive™ GMS, the study will be terminated 
• 
Product performance/product supply issues 
• 
IRB/EC/REB or governing regulatory authority (where applicable) suspension and/or termination 
of the study 
Medtronic reserves the right to suspend or terminate the study at an individual site. Reasons may 

Page 74 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
include, but are not limited to, the following: 
 
• 
Noncompliance with the protocol 
• 
Serious or repeated deviations at the site 
• 
Failure to implement required corrective and preventive actions 
• 
Insufficient enrollment to complete the study within the expected timeframe 
• 
Loss of appropriately trained site personnel 
Investigators are required to notify the IRB/EC/REB of study suspension/termination. For European sites 
the Sponsor will notify the EC of study suspension/termination. Subjects will be notified by the 
investigator of suspension/termination due to unacceptable risk or of termination due to any other cause. 
If, for any reason, Medtronic suspends or prematurely terminates the investigation at an individual 
investigation site, Medtronic shall inform the responsible regulatory authority as appropriate and ensure 
that the IRB/EC/REB is notified, either by the Principal Investigator or by Medtronic. If the suspension or 
premature termination was in the interest of safety, Medtronic shall inform all other Principal 
Investigators and investigational sites. The Principal Investigator or authorized designee shall promptly 
inform the enrolled subjects at his/her investigation site, if appropriate. In case of early investigation site 
suspension or termination subjects will be followed‐up as per standard of care. 
 
16. Records and Reports 
 
 
16.1. Responsibilities of the Investigator 
The investigator is responsible for the preparation, review, and signature (as applicable), and retention 
of the records listed as follows: 
 
• 
All essential correspondence that pertains to the investigation 
• 
Device use/disposition records 
• 
Records of each subject’s case history and exposure to the device. Case histories include the eCRFs 
and supporting data (source documentation), including, for example: 
• 
Signed and dated consent/assent forms 
• 
Medical records, including, for example, progress notes of the physicians, the subject’s hospital 
chart(s) and the nurses’ notes 
• 
All adverse event/device deficiency information 
• 
A record of the exposure of each subject to the BRAIVE system 
• 
Documentation of any deviation from the CIP, including the date and the rationale for such 
deviation 
• 
Signed Investigator Agreement, signed and dated curriculum vitae of the PI, sub‐investigator(s) 
and key members, signed Delegated Task List 
• 
The approved CIP, PI/ICF/Assent and any amendments 
• 
Insurance certificate, where applicable 

Page 75 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Ethics Board approval documentation and voting list 
• 
Sample eCRFs 
• 
Regulatory authority notification and approval documentation 
• 
List of Medtronic/monitor contacts 
• 
List of investigation sites 
• 
Training records 
• 
Disclosure of conflict of interest 
• 
Certification of adequacy of equipment 
• 
Subject Identification & Enrollment Log 
• 
Subject Screening Log 
• 
Clinical investigation report including the statistical analysis 
 
The investigator may withdraw from responsibility to maintain records by transferring custody to 
another person, who will accept responsibility for record and report maintenance. The investigator is 
responsible for the preparation, review, signature, and submission of the reports listed in Table 13 and 
Table 14. These are also subject to inspection by government agencies and must be retained. 
Reports will be submitted to regulatory authorities per local reporting requirements/regulations. 
 
Table 13. Investigator records and reporting responsibilities applicable to the US 
 
Investigator reports applicable to the US 
Report 
Submit To 
Description/Constraints 
Withdrawal of 
Ethics Board 
approval 
Medtronic 
An investigator shall report to Medtronic, within 5 working 
days, a withdrawal of approval by the reviewing IRB of the 
investigator's part of an investigation. (21 CFR 812.150(a)(2)). 
Progress report 
Medtronic 
and Ethics 
Board 
An investigator shall submit progress reports on the 
investigation to Medtronic, the monitor, and the reviewing IRB 
at regular intervals, but in no event less often than yearly. (21 
CFR 812.150(a)(3)). 

Page 76 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Deviations 
Medtronic 
and Ethics 
Board 
An investigator shall notify Medtronic and the reviewing IRB of 
any deviation from the investigational plan to protect the life or 
physical well‐being of a subject in an emergency. Such notice 
shall be given as soon as possible, but in no event later than 5 
working days after the emergency occurred. Except in such an 
emergency, prior approval by Medtronic is required for changes 
in or deviations from a plan, and if these changes or deviations 
may affect the scientific soundness of the plan or the rights, 
safety, or welfare of human subjects, FDA and IRB in 
accordance with 812.35(a) also is required. (21 CFR 
812.150(a)(4)) 
Failure to obtain 
Assent/IC prior to 
investigational 
device use 
Medtronic 
and Ethics 
Board 
If an investigator uses a device without obtaining informed 
consent, the investigator shall report such use to Medtronic 
and the reviewing IRB within 5 working days after the use 
occurs. (21 CFR 812.150(a)(5)) 
Final report 
Medtronic, 
Ethics 
Boards 
An investigator shall, within 3 months after termination or 
completion of the investigation or the investigator's part of the 
investigation, submit a final report to Medtronic and the 
reviewing IRB. (21 CFR 812.150(a)(6)) 
Other 
Ethics 
Board and 
FDA 
An investigator shall, upon request by a reviewing IRB or FDA, 
provide accurate, complete, and current information about 
any aspect of the investigation. (21 CFR 812.150(a)(7)) 
 
Table 14. Investigator records and reporting responsibilities applicable to Europe and 
Canada 
 
 
Investigator reports applicable to Europe and Canada 
Report 
Submit To 
Description/Constraints 
Withdrawal of 
Ethics Board 
approval 
Medtronic 
An investigator shall report to Medtronic if required by local law. 
Progress Report 
Medtronic 
and Ethics 
Board 
Provide if required by local law or Ethics Board. (ISO 14155) 

Page 77 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Deviations 
Medtronic 
and Ethics 
Board 
Any deviation from the CIP shall be recorded together with an 
explanation for the deviation. Deviations shall be reported to 
Medtronic who is responsible for analyzing them and assessing 
their significance. 
Note: When relevant, Ethics Boards or regulatory authorities 
should be informed. (ISO 14155) 
Failure to obtain 
Assent/IC 
Medtronic 
and Ethics 
Board 
IC shall be obtained in writing and documented before a subject 
is enrolled into the clinical investigation. (ISO 14155) 
 
16.2. Responsibilities of Medtronic 
In conducting this study, Medtronic will have certain direct responsibilities and may delegate other 
responsibilities to consultants and/or contract research organizations; however, Medtronic remains 
ultimately responsible for the conduct of the study. 
 
Medtronic will maintain the following records, including but not limited to: 
 
• 
All essential correspondence related to the clinical study 
• 
Signed Investigator Agreement 
• 
Signed and dated current curriculum vitae for each investigator 
• 
Records of device shipment and disposition (shipping receipts, material destruct records, etc.) 
• 
Adverse event and device deficiency information 
• 
Device complaint documentation 
• 
All data forms, prepared and signed by the investigators, and received source documentation and 
core laboratory reports 
• 
CIP, Report of Prior Investigations and subsequent amendments 
• 
Site monitoring reports 
• 
Financial disclosure information 
• 
Study training records for site participants and internal study staff members 
• 
Contact lists of all participating investigators/investigative sites, Ethics Board information, study 
monitors and Medtronic staff members; Medtronic will maintain these lists and provide updates 
to the necessary parties. 
• 
Sample of device labeling attached to the BRAIVE system 
• 
Insurance certificates 
• 
Ethics Board approval documentation and voting list 
• 
Regulatory authority notification and approval documentation 
• 
Statistical analyses 
• 
Clinical investigation report 
 
Medtronic is responsible for the preparation of, the accuracy of the data contained in, the review of and 

Page 78 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
the submission of the reports listed in Table 15, Table 16 and Table 17. 
 
Table 15. Medtronic records and reporting responsibilities applicable to the US 
 
Medtronic reports for US 
Report 
Submit To 
Description/Constraints 
Premature termination 
or suspension of the 
clinical investigation 
Investigators, Ethics 
Board, and relevant 
authorities 
Provide prompt notification of termination or 
suspension and reason(s). (ISO 14155) 
Unanticipated Adverse 
Device Effect (UADE) 
Investigators, Ethics 
Board, FDA, and relevant 
authorities 
Notification within 10 working days after 
Medtronic first receives notice of the effect. 
(21 CFR 812.150(b)(1)) 
Withdrawal of Ethics 
Board approval 
Investigators, Ethics 
Board, FDA, and relevant 
authorities 
Notification within 5 working days after 
receipt of the withdrawal of approval. (21 
CFR 812.150(b)(2)) 
Withdrawal of FDA 
approval 
Investigators, Ethics 
Board, and relevant 
authorities 
Notification within 5 working days after 
receipt of notice of the withdrawal of 
approval. (21 CFR 812.150(b)(3)) 
Investigator List 
FDA 
Submit at 6‐month intervals, a current list of 
the names and addresses of all investigators 
participating in the investigation. (21 CFR 
812.150(b)(4)) 
Progress Reports 
Ethics Board and FDA 
Progress reports will be submitted at least 
annually. (21 CFR 812.150(b)(4)(5), 812.36(f) 
Recall and device 
disposition 
Investigators, Ethics 
Board, relevant 
authorities, and FDA 
Notification within 30 working days after the 
request is made and will include the reasons 
for any request that an investigator return, 
repair, or otherwise dispose of any devices. 
(21 CFR 812.150(b)(6)) 
Failure to obtain 
Assent/IC 
FDA 
Investigator’s report will be submitted to 
FDA within five working days of notification. 
(21 CFR 812.150(b)(8)) 
Final Report 
Investigators, Ethics 
Board, Regulatory 
authorities upon request, 
and FDA 
Medtronic will notify FDA within 30 working 
days of the completion or termination of the 
investigation. A final report will be submitted 
to the FDA, investigators, and Ethics Boards 
within six months after completion or 
termination 
of 
this 
study. 
(21 
CFR 
812.150(b)(7)) 

Page 79 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Deviation 
Investigators 
Ensure that all deviations from the CIP are 
reviewed with the appropriate 
investigator(s), are reported on the case 
report forms and the final report of the 
clinical investigation. 
Site specific deviations will be submitted to 
investigators periodically. (ISO 14155) 
Significant new 
information 
Ethics Board and FDA 
Ensure that the Ethics Boards and FDA are 
informed of significant new information about 
the clinical investigation (ISO 14155) 
 
Table 16: Medtronic records and reporting responsibilities applicable to Canada 
 
 
Medtronic reports for Canada 
Report 
Submit to 
Description/Constraints 
Unanticipated Serious 
Adverse Device 
Effects (USADE) 
Ethics Board, 
investigators, 
Relevant 
Authorities 
Medtronic will notify investigators, Ethics Board and relevant 
authorities in all geographies as soon as possible, but not later 
than 10 calendar days after Medtronic first learns of the effect. 
Serious Adverse 
Device Effects (SADE) 
Relevant 
Authorities 
Medtronic will notify relevant authorities as soon as possible, 
but not later than 10 calendar days after Medtronic first learns 
of the effect. 
DD with SADE 
potential 
Relevant 
Authorities 
Medtronic will notify relevant authorities as soon as possible, 
but not later than 30 calendar days after Medtronic first learns 
of the effect. 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, 
Ethics Board and 
Relevant 
authorities 
Provide prompt notification of termination or suspension and 
reason(s). (ISO14155) 
Withdrawal of Ethics 
Board approval 
Investigators, 
Ethics Board, 
Relevant Authority 
All applicable investigators will be notified only if required by 
local laws or by the Ethics Board. 
 
 
 
 
 
 

Page 80 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Medtronic reports for Canada 
Report 
Submit to 
Description/Constraints 
Withdrawal of 
Regulatory Authority 
approval 
Investigators, 
Ethics Board, and 
Regulatory 
Authority 
Investigators and Ethics Boards will be notified only if 
required by local laws or by the Ethics Board. 
Progress Reports 
Ethics Board and 
Regulatory 
Authority 
This will be submitted to the Ethics Board and/or Regulatory 
Authority if required. 
Recall and device 
disposition 
Regulatory 
Authority 
Notification within 24 hours of a decision to recall. 
Final Report 
Investigators, 
Ethics Board, and 
Regulatory 
Authority (if 
required) 
The investigator shall have the opportunity to review and 
comment on the final report. If a clinical investigator does not 
agree with the final report, his/her comments shall be 
communicated to the other investigator(s). The coordinating 
investigators shall sign the report. (ISO 14155) 
Deviation 
Investigators 
Ensure that all deviations from the CIP are reviewed with the 
appropriate clinical investigator(s), are reported on the CRFs 
and the final report of the clinical investigation. 
Study site specific study deviations will be submitted to 
investigators periodically. (ISO 14155) 
Significant new 
information 
Ethics Board and 
Regulatory 
Authority 
Ensure that the Ethics Boards and Regulatory Authorities 
(where applicable) are informed of significant new information 
about the clinical investigation (ISO 14155) 
 
Table 17: Medtronic records and reporting responsibilities applicable to Europe 
 
Medtronic reports for Europe 
Report 
Submit To 
Description/Constraints 
Unanticipated Serious 
Adverse Device Effects 
(USADE) 
Ethics Board, 
investigators, Competent 
Authorities 
Medtronic will notify investigators, Ethics Board 
and competent authorities in all geographies as 
soon as possible, but not later than 10 working 
days after Medtronic first learns of the effect. 

Page 81 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Serious Adverse Event 
(SAE) 
Ethics Board, Competent 
Authorities 
Submit to Ethics Board per local reporting 
requirement. Submit to Competent Authority per 
local reporting requirement. 
Serious Adverse Device 
Effects (SADE) 
Ethics Board, Competent 
Authorities 
Submit to Ethics Board per local requirement (ISO 
14155). Submit to regulatory authority as per 
local competent authority reporting timelines. 
Device Deficiency that 
might have led to a 
SADE 
Ethics Board, Competent 
Authorities 
Submit to Ethics Board per local requirement. 
Submit to regulatory authority as per local 
competent authority requirement. 
Premature termination 
or suspension of the 
clinical investigation 
Investigators, Ethics 
Board, Relevant Authority 
Provide prompt notification of termination or 
suspension and reason(s). (ISO 14155) 
Withdrawal of Ethics 
Board approval 
Investigators, Ethics 
Board, Relevant Authority 
All applicable investigators will be notified only if 
required by local laws or by the Ethics Board. 
Withdrawal of 
Competent Authority 
approval 
Investigators, Ethics 
Board, and Regulatory 
Authority 
Investigators and Ethics Boards will be notified 
only if required by local laws or by the Ethics 
Board. 
Progress Reports 
Ethics Board, Regulatory 
Authority (if required) 
This will be submitted to the Ethics Board and/or 
Regulatory Authority if required. 
Final Report 
Investigators, Ethics 
Board, and Regulatory 
Authority (if required) 
The investigator shall have the opportunity to 
review and comment on the final report. If a 
clinical investigator does not agree with the final 
report, his/her comments shall be communicated 
to the other investigator(s). The coordinating 
investigators  shall sign the report. (ISO 14155) 
Deviation 
Investigators 
Ensure that all deviations from the CIP are 
reviewed with the appropriate clinical 
investigator(s), are reported on the case report 
forms and the final report of the clinical 
investigation. 
Site specific deviations will be submitted to 

Page 82 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Significant new 
information 
Ethics Board and 
Regulatory Authority 
Ensure that the Ethics Boards and Regulatory 
Authorities (if applicable) are informed of 
significant new information about the clinical 
investigation (ISO 14155) 
 
 
16.3. Final Report 
Medtronic will provide a final written report of the study results according to applicable regulations, and 
will include at a minimum: 
 
• Identification of the device(s) 
 
• Description of the methodology and design of the clinical investigation 
 
• Summary of the deviations from the CIP 
 
• Statistical analysis of the study data 
 
• Critical appraisal of the aims of the study 
 
Medtronic will submit this final report to the PIs for review and shall document and disseminate 
discrepant comments to all study PIs. The Coordinating Investigators will provide their signatures, 
indicating their agreement with the content of the final report. 
 
All required study reports will be submitted to regulatory authorities and Ethics Boards per local reporting 
requirements/regulations. 
 
17. Contact Information 
 
 
17.1. Sponsor contact information 
Detailed sponsor contact information not outlined in the Clinical Investigational Plan will be provided 
under a separate cover. 
 
17.2. Participating Investigators and Investigation Sites 
A complete list of names, addresses, professional positions and emergency contact details of the clinical 
investigators and clinical investigation sites will be distributed under a separate cover.  
 

Page 83 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
17.3.  Reviewing Institutional Review Board 
A complete list of names and addresses of each reviewing Institutional Review Board will be provided 
under a separate cover.  
 
 

Page 84 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
18. History 
 
 
Version 
Summary of changes 
Author(s)/Title 
1.0 
Not Applicable, New Document 
 
Clinical Study 
Manager 
2.0 
• 
Separated safety objective from primary objective 
• 
Updated PedsQL Term and definition throughout document 
• 
Adapted SRS‐22r to SRS‐22 to capture medication use 
• 
Removed 24 months from safety objective and safety 
endpoint 
• 
Updated all secondary endpoints from “Changes in” to 
“Assessment of change from baseline” and added at all 
available follow‐ups to integrate follow‐up until skeletal 
maturity. 
• 
Removed changes in shoulder imbalance from secondary 
endpoints 
• 
Neurological status collection adapted from all follow‐ups to 
preoperative and discharge 
• 
Removed 12 months and 24 months from the adverse event 
and reoperation secondary endpoint 
• 
Updated reference to Appendix E: Medtronic Reusable 
Instruments and Accessories for Use with Braive™ Growth 
Modulation System ‐ Instructions for Use 
• 
Added Appendix F: Medtronic Navigated Manual Reusable 
Instruments for Use with the StealthStation™ System for 
Braive™ Growth Modulation System – Instructions for Use 
Exclusion criteria: 
• 
Added “Concurrent participation in another clinical study 
that may add additional safety risks and/or confound study 
results* 
*Subjects in concurrent studies can only be enrolled with permission 
from Medtronic. Please contact Medtronic’s study manager to 
determine if the subject can be enrolled in the BRAIVE IDE Study.” 
Study Design: 
• 
Added that clinical assessments and radiological evaluation 
will be completed biannually until the subject is skeletally 
mature. 
Sample Size 
, 
Clinical Study 
Manager 

Page 85 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Adapted “40 patients” to “25 patients” 
• 
Adapted “up to 15 sites” to “up to 10 sites” 
Statistics: 
• 
Added that overcorrection will be counted as failure 
Purpose: 
• 
Removed reference to HDE 
Duration: 
• 
Adapted “24 months” to “until skeletal maturity, with an 
expected study duration of 7 years” 
Rational: 
• 
Added “Bracing does not correct the curve; rather it is 
intended to halt the progression of the curve. Bracing is 
considered successful if the curve progresses less than 5 
degrees was added to the rationale” 
• 
Removed “There are no VBT devices approved for this 
pediatric use globally” 
Product receipt and tracking: 
• 
Removed duplicate sentence from product receipt and 
tracking 
• 
8.1 Study population: Removed “current standard of care” 
Subject enrollment: 
• 
Removed “the investigator” 
Schedule of events: 
• 
Added biannually until skeletal maturity to schedule of 
events 
Updated footnotes to match changes 
• 
Pulmonary function (spirometry) adapted from all follow‐ups 
to preoperative and discharge 
• 
Removed surgery indication from pre‐op to match schedule 
of events 
• 
Rephrased what is required when a subject gets enrolled but 
not implanted in surgery section 
All sections that cover enrollment: 
• 
Adapted to “All parents or legal guardians must sign the ICF 
and all subjects need to sign the Assent form prior to 

Page 86 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
performing any study specific procedure” 
Radiological effectiveness endpoints: 
• 
Updated all radiological effectiveness endpoints from 
“Changes in” to “Assessment of change from baseline” and 
added at all available follow‐ups to integrate follow‐up until 
skeletal maturity. 
Subject Withdrawal or Discontinuation: 
• 
Compliance language for follow‐up updated to “Compliance 
with the required follow‐up schedule is essential” and 
adapted language to subjects should not be lost‐to‐follow‐up 
• 
Withdrawal of consent: Added after undergoing the Braive 
Procedure 
Potential Risks: 
• 
Examples of potential risks were removed from the potential 
risks section as all risks are covered in the separate risk 
analysis 
Reporting Adverse Events to Medtronic: 
• 
Corrected table number to 11‐4 for reporting AEs to 
Medtronic 
Statistical Design and Methods: 
• 
Removed reference to the 40 patients from sample size 
section 
• 
Removed: “The primary analysis will be based on the first 25 
patients who are treated with the Braive™ system and have 
reached to 12‐month follow up visit” 
Liability: 
• 
Updated Center for Medicare and Medicaid Services (CMS) 
IDE Study Criteria section 
3.0 
• 
Updated biannual follow‐up to “annual follow‐up until 
skeletal maturity” after 24 months throughout the document 
• 
Added to skeletal maturity “(defined as Risser 5)” throughout 
the document 
, 
Clinical Study 
Manager 
4.0 
Overall: 
• 
Juvenile added as inclusion criteria and in title 
• 
ISO14155:2011 updated to latest version of ISO14155 
throughout document 
, 
Clinical Study 
Manager 
 
, 

Page 87 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Study purpose updated to establish probable benefit and 
evaluate the safety and preliminary effectiveness of the 
Braive™ GMS when used in the treatment of JIS and AIS. 
• 
Local sponsor – Europe updated to Local sponsor – EU Legal 
Representative 
• 
Lead Principal Investigators added 
• 
Cobb angle designation updated to remove “major” 
• 
Primary objective and primary endpoint updated from 12 
months to 24 months 
• 
Safety objective updated to “secondary spinal surgery 
defined 
as 
treatment 
failure 
up 
to 
24 
months 
postoperatively.” 
• 
Safety endpoint updated to secondary spinal surgery defined 
as treatment failure up to 24 months postoperatively 
• 
Updated “patient(s)” to “subject(s)” where appropriate 
• 
Removed full titles of Appendices where appropriate 
throughout document, added statements that they will be 
provided separate from the CIP 
• 
Deleted list of Appendices and all Appendix numbers 
throughout the document 
Synopsis: 
• 
Prospective, multi‐center, single arm added to study type 
• 
External Organizations added 
• 
Indications updated: investigational in US and CA, CE marked 
in EU (within approved indication) 
• 
Investigation Purpose updated for HDE study 
• 
Sample size updated to include maximum number of 
subjects per site 
• 
Primary endpoint, safety endpoint and secondary endpoint 
updated to 24 months 
 
Secondary Endpoints 
 
• 
Updated endpoints to remove “Assessment of” 
• 
Updated secondary endpoint from 12 to 24 months post‐
operative 
• 
Updated definition for individual success 
• 
Added endpoint for change in shoulder imbalance 
• 
Updated the language and added levels to define total 
vertical thoracic spine height and total vertical spine height. 
• 
Updated neurological status collection timepoint from 
baseline and discharge to all available postoperative 
timepoints 
Sr. Clinical 
Research 
Specialist 
 

Page 88 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Updated adverse events to device and procedure related 
adverse events up to 24 months 
• 
Updated “reoperations/revisions/removals” to “secondary 
spinal surgeries” and added timeframe (24 months) 
 
Study Design 
 
• 
Added percent of total population each site can enroll with 
explanation of limiting subjects per site in order to mitigate 
bias 
• 
Updated rationale about outcome of bracing 
• 
Added definition of completion of the clinical study 
• 
Added reasoning for not implementing a control group 
Product Description 
 
• 
Updated Table 4: Braive Instrument Set CFNs to include CE 
Mark CFN 
• 
Added Table 5: Braive Licensing Disc 
• 
Added indications: investigational in US and CA, CE marked 
in EU (within approved indication) 
 
Route of Administration 
 
• 
Added Navigated Surgical Technique 
 
Packaging 
 
• 
Updated “unopened” to “intact” 
• 
Added statement that CE marked devices will be labelled in 
respective local language 
 
Intended Population 
 
• 
Added JIS 
• 
Deleted Risser score of 0‐2 
 
Equipment 
 
• 
Added statement that sites will be able to choose whether to 
implant the system non‐navigated or navigated following the 
respective surgical techniques 

Page 89 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Added name of software company 
 
Product Receipt and Tracking 
 
• 
Added sites as responsible for maintaining device 
accountability logs 
• 
Added navigated instruments and BRAIVE licensing Disc 
Added record maintenance requirement for CE marked 
devices 
Product Return 
 
• 
Added statement that investigational components where 
the packaging is not intact should be returned or disposed of 
appropriately 
• 
Added Braive Instrument Set and applicable geographies to 
unused investigational device return 
 
Exclusion Criteria 
 
• 
Updated pregnancy exclusion criteria to add “within first 12‐
months of the study” 
• 
Removed “pulmonary issue” 
• 
Updated “significant respiratory problems” to “severe 
chronic lung disease (e.g. asthma, bronchiectasis)” 
• 
Reformatted sentence structure for poor bone quality 
exclusion criteria 
 
Schedule of Events 
 
• 
Updated table number to Table 6 
• 
Updated Neurological Status in Table 6 to include 3, 6, 12, 18, 
24 months and annually 
• 
Moved Spirometry in Table 6 from discharge to 3 months 
• 
Updated “Adverse Events” to “Adverse Events and device 
deficiencies” in Table 6 and footnote 
• 
Updated footnote to “probable benefit” and 24 months 
• 
Added O‐Arm, StealthStation and Intraoperative image in 
Table 6 and footnote 
 
Enrollment 
 

Page 90 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Deleted procedures 
• 
Updated “Sample” to “The” Informed Consent and Assent 
forms 
• 
Added (enrollment log) 
Pre‐op 
 
• 
Added left hand X‐ray 
 
Surgery 
 
• 
Added 
O‐Arm 
3D 
projection 
images 
and 
StealthStation Images 
• 
Added Intraoperative images 
 
Discharge Assessment 
 
• 
Removed “Pulmonary Function (Spirometry) 
• 
Added “Study Deviations” 
 
Post‐operative Assessment at 3 months 
 
• 
New section; Split Post‐operative Assessment at 3 months 
and Post‐operative Assessment at 6, 12, 18, 24 months and 
annually into separate sections 
Added Neurological Status and Spirometry 
 
Post‐operative Assessment at 6, 12, 18, 24 months and 
annually 
 
• 
Removed “Study Deviations” from section title 
• 
Added Neurological Status 
• 
Removed “Pulmonary Function (Spirometry)” 
 
O‐Arm and StealthStation Image Acquisition 
 
• 
New section 
 
Intraoperative Image Acquisition 
 
• 
New section 
 

Page 91 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Subject Consent 
 
• 
Added the latest version of ISO 14155 
• 
IRB/EC/REB full spelling replaced with acronyms 
• 
Informed consent process updated from “source” to state 
must be documented in “subject’s medical records” 
• 
Added statement that signed copies of the ICF and assent 
form will also be provided to parent(s)/legal guardians 
• 
Removed “local law” 
 
Secondary effectiveness endpoints 
 
• 
New section 
 
Radiological effectiveness endpoints 
 
• 
Removed “Assessment of” from each endpoint 
• 
Added “except at 24 months” to “Change from baseline in 
Cobb angle at all available postoperative timepoints” 
 
Individual subject success 
 
• 
New section 
 
Safety Endpoint 
 
• 
Safety endpoint updated to “any secondary spinal surgery 
defined 
as 
treatment 
failure 
up 
to 
24 
months 
postoperatively.” 
 
Adverse Events 
 
• 
Updated reference to Table 7 
• 
Updated CEC responsibility 
 
Neurological Status 
 
• 
Updated timepoints for neurological status evaluation 
• 
Updated scale for evaluating neurological status 
• 
Added definition for neurological change and success for 
neurological status 

Page 92 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
Overcorrection 
 
• 
Removed overcorrection of 20 degrees or more being 
considered clinically significant 
• 
Added meaning of negative cobb angle 
 
Types of Subsequent Spinal Surgical Interventions 
 
• 
Updated definitions for revisions, removals, reoperations, 
and other. 
• 
Updated revisions to include two categories, preventative 
and non preventative 
• 
Added 
statement 
“Any 
subsequent 
spinal 
surgical 
intervention will be adjudicated by CEC to determine 
whether it is true treatment failure” 
 
Relatedness of Subsequent Spinal Surgical Interventions 
 
• 
Added “Spinal’ to section title 
• 
Moved statement “A subsequent spinal surgical intervention 
determined as having “possible,” “probable,” or “causal” 
relationship to the Braive™ GMS will be conservatively 
considered as being “related.”” for clarity 
 
 
Recording Data 
 
• 
Updated to “The investigator must ensure that the data 
reported in the eCRF and all other required study reports are 
accurate, complete and reported in a timely manner.” 
 
• 
Clarified discrepancies as “between eCRF and source 
documents” and need to be justified in “writing” 
• 
Added statement that data collected during subject phone 
calls will be considered as source data 
• 
Added information for completing remote visit source 
document worksheet 
• 
Moved statement “The Principal Investigator or an individual 
delegated by the Principal Investigator on the Delegation of 
Authority Log is responsible for documenting and entering 
data for the study on the eCRFs.” for clarity 

Page 93 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Updated “persons” to “site study staff” 
 
Deviation Handling 
 
• 
Removed additional word, “study” 
• 
Updated pregnancy example 
• 
Added COVID‐19 impact 
 
Reporting requirements for study deviations 
 
• 
Added “and Regulatory Authorities (if applicable)” 
• 
Added “Medtronic is responsible for reporting all study 
deviations to Regulatory Authorities as applicable.” 
 
Lost to follow up 
 
• 
Added “When subjects are lost to follow‐up the investigator 
will make efforts to confirm the vital status of the subject, as 
described in the informed consent.” 
 
Potential Risks 
 
• 
Radiation exposure risks added to CIP to meet ISO 
requirements 
 
Risk Minimization, Overall Mitigation Factors, During Surgery, 
During Post‐operative Care, Oversight of Safety, Warning and 
Precautions 
 
• 
New sections added. Risk assessment that existed under 
separate cover is now fully integrated into the CIP to meet ISO 
requirements 
 
Potential Benefits 
 
• 
Updated the primary benefits expected for the subjects 
treated with the Braive GMS 
• 
Added statement that information collected in this study 
may assist in the modification of the existing system, design 
of new products/therapies, and/or IFUs 
 

Page 94 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Risk‐Benefit Rationale 
 
• 
Updated risk‐benefit rationale 
• 
Added statement “All the risks with the device have been 
deemed acceptable and the benefits of participating in the 
study outweigh the risks.” 
 
Adverse Event Definitions/Classifications 
 
• 
Removed reference to ISO14155:2011 throughout section 
• 
Updated Adverse (AE) definition 
• 
Removed “Device Related Adverse Event or” from Adverse 
Device Effect and added note 
• 
Removed “Europe and Canada Reporting Only” from Device 
Deficiency and updated notes 
• 
Updated definition and note for Serious Adverse Event (SAE) 
• 
Updated name from “Serious, Device Related Adverse Event 
or Serious Adverse Device Effect” to Serious Adverse Effect 
(SADE) 
• 
Split “Unanticipated Serious Adverse Device Effect (USADE)” 
from Unanticipated Adverse Device Effect (UADE) and 
updated the definition 
• 
Added Serious Health Threat and definition 
• 
Removed 
MEDDEV 
2.7/3 
reference 
from 
relatedness 
• 
Added severity grading 
• 
Updated 
descriptions 
of 
revision, 
removal, 
reoperation, other and added supplemental fixation 
 
Reporting of Adverse Events 
 
• 
Updated table number to Table 8 and added “Adverse” to 
title 
• 
Updated Table 8 classification responsibilities and added 
expectedness 
 
Not reportable events 
 
• 
Changed “pre‐planned surgical procedure” to “elective or 
preventative medical procedure” 
• 
Removed 
“surgery”, 
“endoscopy”, 
“transfusion”, and “elective” from examples 

Page 95 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Replaced 
“expected 
surgical 
events” 
with 
“Unavoidable Adverse Events (UAE)” 
• 
Updated Table 11‐3 to Table 9. Updated title, event 
descriptions, and time frames 
• 
Added event description and timeframe for back pain and 
shoulder pain 
 
Device Deficiencies 
 
• 
Updated reference of Table 11‐4 to Table 10 
 
Reporting Adverse Events to Medtronic 
 
• 
Updated reference to Table 11‐4 to Table 10 
• 
Removed reference to 24‐month visit 
• 
Removed reference to MDD 93/42/EEC and MEDDEV 2.7/3 
• 
Removed statement “Adverse events will be followed until 
resolved or until study completion, whichever comes first.” 
 
Pregnancy Reporting 
 
• 
Updated to state “If the subject experiences untoward 
medical occurrences during pregnancy or at delivery, these 
should be recorded as an adverse event and reported.” 
• 
Added “If available, outcomes will be collected on both 
mother and child” 
Death 
 
• 
Added UADE 
• 
Removed “If the cause of death is unknown, “death” may
be 
reported 
as 
an 
adverse 
event.” 
 
Medical Monitor and Clinical Events Committee (CEC) 
 
• 
Clarified role of CEC 
• 
Deleted AE classification 
• 
Updated classification for secondary spinal surgical 
interventions to include whether the event is a treatment 
failure 
 
CRO / Core labs 
 

Page 96 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
New section 
 
Sample Size 
 
• 
Updated Table 13‐2 to Table 12 
• 
Updated calculations for sample sizes 
• 
Updated Table 12 with new calculations 
 
Analysis Populations and/or Subset 
 
• 
Updated safety failure to treatment failure 
 
Analysis of Subgroups 
• 
Removed the paragraph about the effect of investigational 
site on the primary outcome tested using an ANOVA model 
 
Safety Analysis 
 
• 
Removed “All the analyses will be conducted based on the 
CEC adjudication of relatedness and seriousness.” 
 
Secondary Safety Endpoint 
 
• 
Updated “all adverse events” to “device or procedure‐
related adverse events up to 24 months.” 
• 
Removed “from pre‐op to post‐op” from changes in 
Neurological Status 
• 
Updated “reoperations/revisions/removals” to “secondary 
spinal surgeries not defined as treatment failure up to 24 
months” 
 
 
Adverse Events 
 
• 
Added procedure‐related adverse events 
• 
Updated “revision, removal, reoperation” to “secondary 
spinal surgeries” 
• 
Updated “AEs related to the components of the surgical 
construct” to “device or procedure‐related AEs and device or 
procedure‐related SAEs” 
 

Page 97 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Subsequent Spinal Surgical Interventions 
 
• 
Update “Subsequent spinal surgical interventions and safety 
failures at the index level(s)” to “Subsequent spinal surgical 
interventions including those that are defined as treatment 
and those that are not defined as treatment failures” 
 
Statement of Compliance 
• 
Removed reference to ISO14155:2011 and MDD 93/42/EEC 
 
Medtronic Representative Role 
 
• 
Added statement that Medtronic personnel may assist with 
collecting image data from the StealthStation and O‐arm 
Monitoring 
 
• 
Added onsite or remotely 
 
Record Retention 
 
• 
Updated record retention requirements 
 
Suspension or Early Termination 
 
• 
Section split into Planned Study Closure and Early 
Termination or Suspension sections 
 
Planned Study Closure 
 
• 
New section 
 
Early Termination or Suspension 
 
• 
New section 
 
Records and Reports 
 
• 
New section, split responsibilities of investigators and 
Medtronic into two sections 
 

Page 98 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Responsibilities of the Investigator 
 
• 
New section; details Investigator records and reporting 
responsibilities applicable to US and Europe 
 
• 
Added table 13 and 14 
 
Responsibilities of Medtronic 
• 
New section; details Medtronic records and reporting 
responsibilities applicable to US and Europe 
• 
Added table 15 and 16 
 
Final Report 
 
• 
Added section 
 
Radiographic Review Core Lab, Software Development Lab, 
and Explant Analysis 
 
• 
Removed sections, included under CRO / Core Labs section 
 
Appendices 
 
• 
Removed section, provided under separate covers 
5.0 
Overall 
 
• 
Clarified which regulations and guidelines apply in the US, 
Europe and Canada. 
• 
Specified ISO14155:2020 version and Declaration of Helsinki 
2013 version. 
• 
Corrected typo for Software Development Lab from Stirling 
to Sterling 
• 
Specified that the safety objective/endpoint is the primary 
safety objective/endpoint 
• 
Added 
Observational 
Radiographic 
Objectives/endpoints 
• 
Clarified that skeletally maturity as defined by Risser 5 will be 
assessed by the imaging vendor 
• 
Added intra‐operative radiological assessment for Cobb 
angle to assess correction achieved on the table 
 
Clinical Study 
Manager 

Page 99 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Updated in/exclusion criteria (detailed changes can be found 
in that specific section below) 
• 
Added Physical Assessment and unscheduled visit to 
schedule of events 
• 
Moved spirometry assessment from 3 Months FU to 12 
Months FU visit since that is a more appropriate timepoint 
to assess this. 
• 
Clarified that eligibility report from imaging vendor must be 
received prior to surgery and extended the period for 
acquiring X‐ray images from 6 weeks to 3 months prior to 
surgery since that is considered acceptable by the steering 
committee. 
• 
Added Observational radiographic endpoints to Statistics 
section and updated analysis population from Intention to 
Treat to primary analysis population. 
• 
Updated 
the 
wording 
radiological 
to 
radiographic 
assessment throughout for consistency. 
 
 
Background 
 
• 
Corrected ‘  ̊’ to degrees for consistency 
 
Study Design 
 
• 
Clarified that failed conservative treatment is per 
investigator’s assessment. 
 
 
Product description 
 
• 
Updated table 4 to include commercially available Quick 
Connect Ratcheting Handle and Egg Handle 
• 
Generalized reference to IFUs instead of listing them all out. 
• 
Clarified that also intra‐operative imaging will be shared with 
Sterling for the patients who give consent for this. 
Clarified requirements for product accountability, storage 
and return that is also applies for CE marked devices provided 
free of charge but that it does not apply for CE marked 
devices obtained via the commercial route. Added the 
requirement to collect received by name, date of return and 
returned by name (including reason for return) 
 
 

Page 100 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
Subject enrollment 
 
• 
Added the use of a subject screening log 
 
In/Exclusion criteria 
 
• 
Combined skeletally immature with Sanders Score inclusion 
criterium 
• 
Clarified that failed conservative care is per investigator’s 
assessment 
• 
Clarified that Authorization to Use and Disclose Health 
Information only should be signed if applicable 
• 
Updated exclusion criterium to indicate that the subject 
should not become pregnant within the first 24 months of 
the study instead of 12 months. 
• 
Clarified that inadequate tissue coverage will be determined 
as per investigator’s assessment 
• 
Clarified that major psychiatric disorders/history of drug 
abuse patients are excluded if it interferes with the subject’s 
ability to comply with the study instructions or might 
confound study interpretation and that DSM‐5 can be used 
as a reference since it is not common in all regions to use this. 
 
 
Diagnostic tests 
 
• 
Added spirometry data collection requirements. 
 
Radiographic assessment 
 
• 
Clarified that images may be used for AE and DD analysis. 
• 
Added O‐arm 3D Projection Images, StealthStation DICOM, 
Intraoperative AP fluoroscopy since these are also collected 
and forwarded to the core lab. 
 
O‐arm and Stealth Station Image Acquisition and 
Intraoperative Image Acquisition 
 
• 
Clarified secondary use of the images. 
 
Assessment of Effectiveness 
 

Page 101 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
• 
Added definition for clinically significant overcorrection 
• 
Specified that additional analysis will be performed by 
comparing 
the 
postop 
measurements 
with 
the 
measurements prior to discharge. In addition, for Cobb 
angle, the measurement prior to discharge will also be 
compared with the intra‐operative measurement. These 
additional measurements of change are described in the 
Radiographic Evaluation Protocol. 
 
 
Subsequent Spinal Surgical Intervention 
 
• 
Clarified that subjects experiencing a treatment failure as 
assessed by the CEC will only be followed up for safety and 
radiographic imaging until skeletally mature since for the 
efficacy endpoints and neurological status the analysis will 
be carried forward. 
 
 
Deviation handling 
 
• 
Clarified that deviations for enrolled subject does not meet 
in/exclusion criteria only apply in case these criteria are 
assessed by the investigator and not the independent 
radiographic review core lab. 
 
 
Reporting Adverse Events to Medtronic 
 
Removed immediate (no later than 3 calendar days) ADE or 
Device Related AE reporting from investigator to Medtronic 
since there is no regulatory  requirement  to  report  it  
within  these timelines so it will now be covered by timely 
reporting. 
 
 
Analysis populations and/or subset 
 
• 
Changed Intent to Treat population to Primary Analysis 
population 
• 
Clarified that for treatment failure subjects also the 
neurological status will be carried forward 
• 
Added stratification of primary endpoint based on degree of 
baseline curve flexibility 
 

Page 102 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
Medtronic representative role 
 
• 
Added assisting with device data collection and device and 
tissue explant retrieval activities. 
 
 
Planned Study Closure 
 
• 
Removed requirement to send initial study closure letter to 
initiate study closure since usually study closure is initiated 
by scheduling the close out visits. 
 
 
Investigator and Medtronic records and reporting responsibilities 
 
• 
Added requirements for Canada and updated European 
requirements in alignment with local regulations. 
• 
Site specific deviations will be reported to the investigators 
on a periodic basis instead of quarterly 
• 
Final report will be signed by the coordinating investigators 
instead of all investigators as required per ISO14155:2020 
Final Report 
Final report will be signed by the coordinating investigators instead 
of lead principal investigators as required per ISO14155:2020 
 
6.0 
 
Overall 
 
• 
Removed Oracle Clinical from Remote Data Capture System 
to not be too prescriptive. 
• 
Added secondary endpoint to assess TL/L cobb angle 
• 
Added observational radiographic endpoint to assess PT 
cobb angle 
• 
Added Main Thoracic to cobb angle for clarity considering we 
are now also assessing PT and TL/L cobb angles. 
• 
Removed intra‐op cobb angle assessment since this will not 
be done as part of the study but only for future development 
purposes 
• 
Added that in case subjects do not undergo the Braive GMS 
procedure as defined in the CIP the Medtronic study 
manager should be contacted to determine whether subject 
should be exited or not. 
Title page 
, 
Clinical Study 
Manager 

Page 103 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
• 
Updated Medical expert contact details 
Background 
 
• 
Removed duplicate sentence 
Primary safety objective 
 
• 
Added clarification note that secondary spinal surgeries and 
subsequent 
spinal 
surgical 
interventions 
are 
used 
interchangeably. 
Duration 
 
• 
Updated enrollment period to approximately 18 months. 
Product description 
 
• 
Added BRAID Long 
• 
Added tensioner and threaded handle 
In/Exclusion Criteria 
 
• 
Clarified cobb angle to be main thoracic 
• 
Updated Consent/Assent language to indicate it should be 
obtained per local requirement 
• 
Added examples of spinal MRI abnormalities 
Schedule of Events 
 
• 
Removed O‐arm 3D projection images 
Enrollment and Subject Consent 
 
• 
Updated consent/assent language to make it more general 
and to align with country regulations. 
Neurological status 
 
• 
Removed pin prick assessment from sensory function and 
corrected to T1‐S1 assessment 
Overcorrection 
 
• 
Specified that clinically significant overcorrection must be 
reported as an ADE 
Subsequent spinal surgical interventions 
 
• 
Removed duplicate paragraphs/sections to make the 

Page 104 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
document leaner. 
• 
Updated definitions to make it more clear 
Recording data 
 
• 
Added that for instrument accountability the CRF will be 
the source. 
AE/DD definitions/classification 
 
• 
Added ISO14155:2020 references 
• 
Added 
Device 
and 
Procedure 
relatedness 
classification for CEC 
• 
Added date site became aware of the event as minimum 
requirement to be reported 
DMC 
 
• 
Frequency of meetings aligned with DMC charter 
 
CRO/Core labs 
• 
Clarified that Sterling Medical Devices is not part of the study 
but images from the subjects who give consent will be used 
for future software development 
Statistical Design and Methods 
 
Added that any additional interim analysis will be documented in the 
SAP 
7.0 
Overall 
• 
Documentation of decision to discontinue the BRAIVE 
program. The CIP has been updated accordingly to reflect the 
changes.  
• 
Enrollment stopped when 10 subjects were enrolled. 
• 
Decision to not renew EC certification for the Braive GMS into 
the European Market.  
• 
Relevant changes from most recent Clinical Investigation Plan 
Medtronic template version E have been implemented in the 
applicable sections. 
• 
Removed external vendors: Explant and NAMSA 
 
Study endpoints:  
• 
Updated study purpose and endpoints due to discontinuation 
of the BRAIVE program.  
• 
Main focus on device/procedure safety: Updated primary 
endpoint “The primary safety endpoint is any secondary 
 
Clinical Study 
Manager 

Page 105 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
spinal surgery defined as treatment failure up to 24 months 
postoperatively” to “device‐related adverse events up to 24 
month follow up”. 
• 
Main Thoracic Cobb angle is a secondary endpoint 
• 
Instrumented Cobb Angle added as an endpoint (already 
collected in previous CIP version) 
• 
Removal of the following endpoints: Individual Subject 
Success, PedsQL, shoulder imbalance endpoint, T1-L1 length, 
disc wedging angle and Neurological status.  
Schedule of Events 
• 
Visits windows were widened to allow the investigators to 
plan the patient visits according to their growth.  
• 
Updated Neurological Status (collected at preop and 
discharge) 
• 
Updated pulmonary function (collected at preop) 
• 
Updated PedsQL (collected at preop) 
• 
Risser score: mandatory from 24 months onwards  
 
Radiographic evaluation:  
• 
Radiographic images will be evaluated by investigators. This is 
including radiographic endpoints assessment and Risser score 
evaluation (to assess skeletal maturity). 
• 
Radiographic measures will be performed according to site 
standard of care (except for Risser score). 
• 
Radiographic Core Lab had been used for eligibility 
assessment for all patients enrolled in the study.  
 
Study committee/External organization 
• 
Removal of CEC review because this committee was assessing 
secondary spinal surgeries for the primary safety endpoint 
analysis, which was modified.  
• 
Explant analysis: the decision has been made that explanted 
device will be analyzed following Medtronic processes. The 
Histology lab and Analysis lab for explanted devices have been 
removed.  
• 
Removal of DMC, instead, a steering committee and 
Medtronic medical advisor will monitor the safety of 
investigational treatment. 
• 
Removal of Sterling Medical Devices reference for the 
software development.  
• 
Removal of imaging core lab MMI: Pre-Op radiographic 
measurements have been performed by MMI for subject 
eligibility assessment.  All other radiographic measurements 

Page 106 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
will be performed by the study site as site standard of care.  
 
Statistical design and Methods:  
• 
Adaptation of statistical analysis to updated endpoints 
• 
Adaptation of sample size due to enrollment stop 
• 
Removal of Per Protocol population analysis 
• 
Removal of subgroup analysis due to sample size 
 
Others 
• 
Unavoidable AE: Added non-serious Pneumothorax, 
Supplemental Oxygen, Blood loss less than 800cc as 
unavoidable AE.  
• 
Publication: due to limited data availability, publication 
strategy has been updated. 
 
 
 

Page 107 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
19. References 
 
1. Cheng JC, Castelein RM, Chu WC, Danielsson AJ, Dobbs MB, Grivas TB, et al. Adolescent idiopathic 
scoliosis. Nat Rev Dis Primers. 2015;1:15030. 
2. Grivas TB, Vasiliadis E, Mouzakis V, Mihas C, Koufopoulos G. Association between adolescent 
idiopathic scoliosis prevalence and age at menarche in different geographic latitudes. Scoliosis. 
2006;1:9. 
3. Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, et al. 2016 SOSORT 
guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis 
Spinal Disord. 2018;13:3. 
4. Charles YP, Daures JP, de Rosa V, Dimeglio A. Progression risk of idiopathic juvenile scoliosis during 
pubertal growth. Spine (Phila Pa 1976). 2006;31(17):1933‐42. 
5. Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. 
Lancet. 2008;371(9623):1527‐37. 
6. Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic 
scoliosis. N Engl J Med. 2013;369(16):1512‐21. 
7. Sanders JO, Newton PO, Browne RH, Katz DE, Birch JG, Herring JA. Bracing for idiopathic scoliosis: 
how many patients require treatment to prevent one surgery? J Bone Joint Surg Am. 
2014;96(8):649‐53. 
8. Richards BS, Bernstein RM, D'Amato CR, Thompson GH. Standardization of criteria for adolescent 
idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine 
(Phila Pa 1976). 2005;30(18):2068‐75; discussion 76‐7. 
9. Karol LA. Effectiveness of bracing in male patients with idiopathic scoliosis. Spine (Phila Pa 1976). 
2001;26(18):2001‐5. 
10. Newton PO, Ohashi M, Bastrom TP, Bartley CE, Yaszay B, Marks MC, et al. Prospective 10‐year 
follow‐up assessment of spinal fusions for thoracic AIS: radiographic and clinical outcomes. Spine 
Deform. 2020;8(1):57‐66. 
11. Danielsson AJ, Nachemson AL. Radiologic findings and curve progression 22 years after treatment 
for adolescent idiopathic scoliosis: comparison of brace and surgical treatment with matching 
control group of straight individuals. Spine (Phila Pa 1976). 2001;26(5):516‐25. 
12. Danielsson AJ, Nachemson AL. Back pain and function 23 years after fusion for adolescent idiopathic 
scoliosis: a case‐control study‐part II. Spine (Phila Pa 1976). 2003;28(18):E373‐83. 
13. Danielsson AJ, Romberg K, Nachemson AL. Spinal range of motion, muscle endurance, and back pain 
and function at least 20 years after fusion or brace treatment for adolescent idiopathic scoliosis: a 
case‐control study. Spine (Phila Pa 1976). 2006;31(3):275‐83. 
14. Gotze C, Liljenqvist UR, Slomka A, Gotze HG, Steinbeck J. Quality of life and back pain: outcome 16.7 
years after Harrington instrumentation. Spine (Phila Pa 1976). 2002;27(13):1456‐63; discussion 63‐4. 
15. Mariconda M, Galasso O, Barca P, Milano C. Minimum 20‐year follow‐up results of Harrington rod 
fusion for idiopathic scoliosis. Eur Spine J. 2005;14(9):854‐61. 
16. Akazawa T, Kotani T, Sakuma T, Minami S, Torii Y, Orita S, et al. Midlife changes of health‐related 
quality of life in adolescent idiopathic scoliosis patients who underwent spinal fusion during 
adolescence. Eur J Orthop Surg Traumatol. 2018;28(2):177‐81. 

Page 108 of 108 
BRAIVE IDE Study - Clinical Investigation Plan 
#MDT19009SD1901 
Version 7.0; 07 June 2023 
 
Medtronic Controlled Information 
This document is electronically controlled 
 
 
 
056-F275, v B Clinical Investigation Plan Template 
 
17. Sudo H, Ito M, Kaneda K, Shono Y, Abumi K. Long‐term outcomes of anterior dual‐rod 
instrumentation for thoracolumbar and lumbar curves in adolescent idiopathic scoliosis: a twelve to 
twenty‐three‐year follow‐up study. J Bone Joint Surg Am. 2013;95(8):e49. 
18. Lykissas MG, Jain VV, Nathan ST, Pawar V, Eismann EA, Sturm PF, et al. Mid‐ to long‐term outcomes 
in adolescent idiopathic scoliosis after instrumented posterior spinal fusion: a meta‐analysis. Spine 
(Phila Pa 1976). 2013;38(2):E113‐9. 
19. Marks MC, Bastrom TP, Petcharaporn M, Shah SA, Betz RR, Samdani A, et al. The Effect of Time and 
Fusion Length on Motion of the Unfused Lumbar Segments in Adolescent Idiopathic Scoliosis. Spine 
Deform. 2015;3(6):549‐53. 
20. Samdani AF, Ames RJ, Kimball JS, Pahys JM, Grewal H, Pelletier GJ, et al. Anterior vertebral body 
tethering for idiopathic scoliosis: two‐year results. Spine (Phila Pa 1976). 2014;39(20):1688‐93. 
21. Samdani AF, Ames RJ, Kimball JS, Pahys JM, Grewal H, Pelletier GJ, et al. Anterior vertebral body 
tethering for immature adolescent idiopathic scoliosis: one‐year results on the first 32 patients. Eur 
Spine J. 2015;24(7):1533‐9. 
22. Ames RJS, A.F.; Betz, R.R. Anterior Scoliosis Correction in Immature Patients with Idiopathic Scoliosis. 
Operative Techniques in Orthopaedics. 2016;26(4):247‐57. 
23. Hasler CC, Wietlisbach S, Buchler P. Objective compliance of adolescent girls with idiopathic scoliosis 
in a dynamic SpineCor brace. J Child Orthop. 2010;4(3):211‐8. 
24. Dolan LA, Wright JG, Weinstein SL. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J 
Med. 2014;370(7):681. 
25. Rowe D. THE SCOLIOSIS RESEARCH SOCIETY BRACE MANUAL: Introduction. 2003. Available from: 
Scoliosis Research Society (SRS) Website: https://www.srs.org/UserFiles/file/bracing‐ 
manual/section1.pdf. 
26. Price CT, M.F. A, Richards BS, d’Amato C. Alternative Treatments for Scoliosis. 2000. 
27. Crawford CH, 3rd, Lenke LG. Growth modulation by means of anterior tethering resulting in 
progressive correction of juvenile idiopathic scoliosis: a case report. J Bone Joint Surg Am. 
2010;92(1):202‐9. 
28. Sarlak AY, Atmaca H, Buluc L, Tosun B, Musaoglu R. Juvenile idiopathic scoliosis treated with 
posterior arthrodesis and segmental pedicle screw instrumentation before the age of 9 years: a 5‐ 
year follow‐up. Scoliosis. 2009;4:1. 
29. Newton PO, Kluck DG, Saito W, Yaszay B, Bartley CE, Bastrom TP. Anterior Spinal Growth Tethering 
for Skeletally Immature Patients with Scoliosis: A Retrospective Look Two to Four Years 
Postoperatively. J Bone Joint Surg Am. 2018;100(19):1691‐7.