VERITAS - A Study to Demonstrate the Value of Multiple Modalities Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
Phase: NA
Conditions: Chronic Pain, Back Pain
Sponsor: Boston Scientific Corporation

Form/Template 90702637 Rev/Ver AL 
VERITAS Study Protocol, 92125597, Rev/Ver E 
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A Study to Demonstrate the Value of Multiple Modalities using the Spectra 
WaveWriter™ Spinal Cord Stimulator System in the Treatment of 
Chronic Pain 
 
VERITAS Study  
 
CLINICAL INVESTIGATION PLAN 
 
A4064 
 
Sponsored By 
Boston Scientific Neuromodulation Corporation  
25155 Rye Canyon Loop 
Valencia, CA 91355 
United States of America 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 
 
 
 
 
 
 
 
 

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Contact Information 
Role 
Contact  
Clinical Contacts 
Megan Cease, PMP, CCRA 
Manager II, Clinical Research 
Boston Scientific Neuromodulation Corporation 
25155 Rye Canyon Loop 
Valencia, CA 91355  
Telephone: (661) 902-6615  
Fax: (661) 949-4592   
Email: megan.cease@bsci.com 
 
Roshini Jain  
Director, Clinical Sciences and Scientific Communications 
Clinical Research Department 
Boston Scientific Neuromodulation 
25155 Rye Canyon Loop 
Valencia, CA 91355 USA 
Telephone: (661) 949-4350 
Fax: (661) 949-4592 
Email: Roshini.jain@bsci.com 
Coordinating Principal 
Investigator 
James North, M.D. 
The Center for Clinical Research 
145 Kimmel Park Drive, Suite 330 
Winston-Salem, NC  27103 
 
 
 

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Original Release: June 30, 2017 
Current Version: 10 May 2019  
Revision History 
Revision 
Number 
Release Date 
Template 
number and 
version 
Section 
Change 
Reason for Change 
A 
June 30, 2017 
90702637 
Rev/Ver AH 
N/A 
N/A 
N/A – Internal use only 
B 
July 12, 2017 
90702637 
Rev/Ver AH 
N/A 
Administrative 
corrections 
Correction 
C 
September 18, 
2017 
90702637 
Rev/Ver AH 
5, 16, 
20 
Removed 
investigational 
sub-perception 
programming 
Programming per the 
approved Directions for 
Use 
D 
March 5, 2018 
90702637 
Rev/Ver AH 
All 
sections 
• Increased the 
number of sites 
• Updated the 
Indication For 
Use and study 
eligibility 
criteria  
• 
Increased the number 
of sites 
• 
Updated Indication 
For Use  
E 
May 10, 2019 
90702637 
Rev/Ver AL 
All 
sections 
• Updated the 
analysis 
• Updated study 
follow-up 
• Updated the analysis 
• Updated study follow-up 
 
 

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2. Protocol Synopsis 
VERITAS Study  
A Study to Demonstrate the Value of Multiple Modalities using the Spectra 
WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain 
Primary 
Objective 
To demonstrate the value of multiple modalities and sustained clinically 
significant pain relief in patients with chronic pain when using the 
Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) 
System. 
Secondary 
Objectives  
To determine the impact of Spectra WaveWriter SCS System on global 
patient outcomes including quality of life, patient preference, etc.   
Indication(s) for 
Use  
The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is 
indicated as an aid in the management of chronic intractable pain of the 
trunk and/or limbs, including unilateral or bilateral pain associated with 
the following: failed back surgery syndrome, Complex Regional Pain 
Syndrome (CRPS) Types I and II, intractable low back pain and leg 
pain. 
Device 
BSC Spectra WaveWriter™ SCS System 
Study Design 
Prospective, multi-center, open-label, single-arm study with an adaptive 
design 
Planned 
Number of 
Subjects 
Up to 64 activated subjects. 
Planned 
Number of 
Investigational 
Sites / Countries 
Up to 20 sites in the United States. 
Primary 
Endpoint 
Proportion of subjects with 50% or greater reduction from Baseline Visit 
in average overall pain intensity at 3 months post activation, with no 
increase in baseline average daily opioid medications used to treat pain. 

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VERITAS Study  
A Study to Demonstrate the Value of Multiple Modalities using the Spectra 
WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain 
Secondary 
Endpoints 
The following secondary endpoints will be evaluated. Assessments 
required for deriving each endpoint are denoted in parentheses. 
• Change in overall pain intensity from Baseline Visit to 3 months 
post activation Visit (VRS)  
• Percent Pain Relief in overall pain at 3 months post activation 
Visit (PPR) 
• Patient global impression of change at 3 months post activation 
Visit (PGI-C) 
• Clinician global impression of change at 3 mos. post activation 
Visit (CGI-C) 
• Treatment Satisfaction at 3 months post activation Visit (TSQM-
9m) 
• Change in disability from Baseline Visit to 3 months post 
activation Visit (ODIv2.1a) 
Exploratory 
Endpoints  
The following exploratory endpoints will be evaluated. Assessments 
required for deriving each endpoint are denoted in parentheses 
• Number of patient preferred modalities at 6 months, 9 months, 
and Year 1 post activation Visit (Preference Questionnaire) 
• Satisfaction with each modality at 3 months, 6 months, 9 months 
and Year 1 post activation Visits (Patient Remote Control) 
• Change in average overall pain intensity from Baseline Visit to 6 
months, 9 months and Year 1 post activation Visits (VRS) 
• Change in average low back pain intensity from Baseline Visit to 
3 months, 6 months, 9 months and Year 1 post activation Visits 
(VRS) 
• Change in average leg pain intensity from Baseline Visit to 3 
months, 6 months, 9 months and Year 1 post activation Visits 
(VRS) 
• Change in average overall pain intensity from Baseline Visit to 3 
months, 6 months, 9 months and Year 1 post activation Visits 
(NRS) 

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VERITAS Study  
A Study to Demonstrate the Value of Multiple Modalities using the Spectra 
WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain 
• Change in average low back pain intensity from Baseline Visit to 
3 months, 6 months, 9 months and Year 1 post activation Visits 
(NRS) 
• Change in average leg pain intensity from Baseline Visit to 3 
months, 6 months, 9 months and Year 1 post activation Visits 
(NRS) 
• Percent pain relief of overall pain at 6 months, 9 months and 
Year 1 post activation Visits (PPR) 
• Percent pain relief of low back pain at 3 months, 6 months, 9 
months and Year 1 post activation Visits (PPR) 
• Percent pain relief of leg pain at 3 months, 6 months, 9 months 
and Year 1 post activation Visits (PPR) 
• Clinician global impression of change at 6 months, 9 months and 
Year 1 post activation Visits (CGI-C) 
• Patient global impression of change at 6 months, 9 months and 
Year 1 post activation Visits (PGI-C) 
• Treatment satisfaction at 3 months, 6 months, 9 months and Year 
1 post activation Visits (TSQM-9m) 
• Change in quality of life from Baseline Visit to 3 months, 6 
months, 9 months and Year 1 post activation Visits (SF-36v2) 
• Change in disability from Baseline Visit to 6 months, 9 months 
and Year 1 post activation Visits (ODIv2.1a) 
Health 
Economics 
Endpoints 
• Economic value at Year 1 post activation (RUI, EQ-5D-5L, 
Concomitant Medications, Procedure Information) 
• Change in work-related productivity from Baseline to Year 1 
post activation (WPAI-SHP v2.0) 
• Change in Quality of life from Baseline Visit to 3 months, 6 
months, 9 months and Year 1 post activation (EQ-5D-5L) 
Safety 
Parameters 
Rates of occurrence of all device and procedure related non-serious 
adverse events, all serious adverse events, and unanticipated adverse 
events through the end of the study. 

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VERITAS Study  
A Study to Demonstrate the Value of Multiple Modalities using the Spectra 
WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain 
Follow-up 
Schedule 
Study events occur at the following time points: 
• Screening  
• Opioid Medication Lock Visit (Up to 35 days following 
Informed Consent) 
• Baseline Period (14 days) 
• Baseline Visit (0 - 7 days post Baseline Period) 
• Implant Procedures (up to 90 days post Baseline Visit)  
• Healing Period (0 - 28 days) 
• Activation Visit  (Day 0) 
• Programming Period (up to 70 days) 
• Programming Lock Visit (70 ± 14 days) 
• Evaluation Period  
• 3 Month Visit (90 + 14 days post Activation Visit) 
• 6-Month Visit (180 ± 30 days post Activation Visit) 
• 9-Month Visit (270 ± 30 days post Activation Visit) 
• Year 1 Visit (365 ± 30 days post Activation Visit) 
Study Duration Overall study duration is anticipated to take approximately 34 months 
from first patient enrollment to end of study close out activities. 
Key Inclusion 
Criteria 
IC1. 
Chronic pain of the trunk and/or limbs for at least 6 months  
IC2. 
No back surgery within 6 months prior to Screening 
IC3. 
Average overall pain intensity (leg and/or low back pain) of 6 or 
greater on a 0-10 numerical rating scale at Baseline Visit based 
on 7-day recall 
IC4. 
If taking prescription opioids for primary chronic pain complaint 
(low back and/or leg pain), must have been on a stable 
prescription (same drug(s) and dose(s)) 30 days prior to 
Screening 
IC5. 
Consumed an average total daily morphine equivalent of ≤200 
mg during the 30 days prior to Screening 

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VERITAS Study  
A Study to Demonstrate the Value of Multiple Modalities using the Spectra 
WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain 
IC6. 
Willing and able to comply with all protocol-required procedures 
and assessments/evaluations  
IC7. 
Baseline Oswestry Disability Index score ≥40 and ≤80 
IC8. 
22 years of age or older when written informed consent is 
obtained  
IC9. 
Eligible candidate for SCS from a psychological and psychiatric 
standpoint as determined within 180 days prior to Baseline Visit, 
per site’s routine screening process  
IC10. Able to independently read and complete all questionnaires and 
assessments provided in English 
IC11. If female of childbearing potential: not pregnant, as evidenced 
by a negative pregnancy test at Screening 
IC12. Subject signed a valid, IRB-approved informed consent form 
(ICF) provided in English 
Key Exclusion 
Criteria 
EC1. Average leg pain intensity is greater than average low back pain 
intensity as reported during Baseline Period 
EC2. Patient exhibits catastrophization based on physician evaluation 
(e.g., average overall daily pain intensity of 10 on a 0-10 
numerical rating scale, every day during the 7 days prior to 
Screening, based on patient recall) 
EC3. Radiographic evidence of spinal instability requiring fusion 
EC4. Primary pain complaint of vascular origin (e.g. peripheral 
vascular disease) 
EC5. Spinal pain secondary to neoplasm, infection, autoimmune 
disorder with spinal involvement, or a spinal metabolic disorder  
EC6. Visceral pain referred to the low back and/or legs 
EC7. Any pain-related diagnosis or medical/psychological condition 
that, in the clinician’s best judgment, might confound reporting 
of study outcomes (e.g. pelvic pain, anginal pain, chronic 
migraine, brain or spinal cord tumor) 
EC8. Require implantation of lead(s) in the cervical epidural space 

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VERITAS Study  
A Study to Demonstrate the Value of Multiple Modalities using the Spectra 
WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain 
EC9. Current systemic infection, or local infection in close proximity to 
anticipated surgical field, at Screening 
EC10. High surgical risk 
EC11. Body mass index ≥ 45 at Screening 
EC12. Terminal illness with anticipated survival < 12 months 
EC13. Current condition associated with risk of immunocompromise 
that might increase risk of infection during study duration  
EC14. Currently on any anticoagulant medications that cannot be 
discontinued during perioperative period 
EC15. Significant cognitive impairment at Screening that, in the opinion 
of the Investigator, would reasonably be expected to impair the 
study candidate’s ability to participate in the study 
EC16. Participating (or intends to participate) in another drug or device 
clinical trial that may influence the data that will be collected for 
this study 
EC17. Previous spinal cord stimulation trial or is already implanted with 
an active implantable device(s) (e.g. pacemaker, drug pump, 
implantable pulse generator) 
EC18. A female who is breastfeeding 
EC19. A female of childbearing potential planning to get pregnant 
during the course of the study or not using adequate 
contraception  
EC20. Plan to receive any massage or manipulation directly over the 
leads or by the anticipated location of the IPG or treatments that 
involve sudden jerking motions of the torso at any time during 
the course of the study 
EC21. A condition currently requiring or likely to require the use of MRI 
or diathermy 
EC22. Any injury or medical/psychological condition that might be 
significantly exacerbated by the implant surgery or the presence 
of an implantable stimulator or otherwise compromise subject 
safety 
EC23. Unable to operate the study device    

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VERITAS Study  
A Study to Demonstrate the Value of Multiple Modalities using the Spectra 
WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain 
Statistical Methods  
Primary 
Statistical 
Hypothesis 
Proportion of subjects with 50% or greater reduction from Baseline Visit 
in average daily overall pain intensity at 3 months is non-inferior to the 
Objective Performance Criteria (OPC) of 40%.   
H0:  πopc  -  πt > 0.20 
 
H1:  πopc  -  πt  < 0.20 
Where πt is the proportion of subjects with 50% or greater reduction 
from Baseline in average daily overall pain intensity at 3 mos. post 
activation with no increase in baseline average daily pain medications 
using Spectra WaveWriter. 
Statistical Test 
Method 
The 95% confidence interval of πopc - πt will be computed. The study 
will be considered a success if, using the Intent-To-Treat (ITT) analysis, 
the upper bound of the two-sided 95% confidence interval for the 
difference is less than 0.20.   
Sample Size 
Parameters 
Test significance level (α) 
           0.025 
1 or 2 sided test                            
1 
Difference in Response (ε) 
0.00 
Non-inferiority margin (δ) 
           0.20 
OPC                
 
 
0.40 (Kumar et al) 
Power (1- β)                                     0.90 
N 
 
 
 
 
58 
Attrition (%)                                     10 
N 
                                                64 
Interim 
Analysis 
The study will have a total of three looks, with two interim analyses at: 
 
• 18 activated subjects at 3-Month Visit: futility and effectiveness 
stopping 
• 45 activated subjects at 3-Month Visit: futility and effectiveness 
stopping 

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VERITAS Study  
A Study to Demonstrate the Value of Multiple Modalities using the Spectra 
WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain 
The adaptive design will use the Lan-DeMets group sequential method 
(Lan and DeMets 1983) with the O’Brien-Flemming α-spending 
function (O'Brien and Fleming 1979) and Pocock β-spending function 
(Pocock 1977). 
 
 
 

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3. Table of Contents 
1. 
TITLE PAGE  .......................................................................................................................1 
2. 
PROTOCOL SYNOPSIS .........................................................................................................4 
3. 
TABLE OF CONTENTS .......................................................................................................12 
3.1. Table of Figures .....................................................................................................16 
3.2. Table of Tables ......................................................................................................16 
4. 
INTRODUCTION ................................................................................................................17 
4.1. Chronic Intractable Pain ......................................................................................17 
4.2. Spinal Cord Stimulation .......................................................................................17 
5. 
DEVICE DESCRIPTION ......................................................................................................18 
6. 
STUDY OBJECTIVES .........................................................................................................18 
6.1. Primary Objective .................................................................................................18 
6.2. Secondary Objective .............................................................................................18 
7. 
STUDY ENDPOINTS ...........................................................................................................18 
7.1. Primary Endpoint .................................................................................................18 
7.2. Secondary Endpoints ............................................................................................18 
7.3. Exploratory Endpoints .........................................................................................19 
7.4. Health Economic Endpoints .................................................................................20 
7.5. Primary Safety Parameters ..................................................................................20 
8. 
STUDY DESIGN .................................................................................................................20 
8.1. Scale and Duration ................................................................................................20 
8.1.1. 
Treatment ..................................................................................................21 
8.2. Justification for the Study Design ........................................................................21 
9. 
SUBJECT SELECTION ........................................................................................................22 
9.1. Study Population and Eligibility ..........................................................................22 
9.2. Inclusion Criteria ..................................................................................................22 
9.3. Exclusion Criteria .................................................................................................23 
10. SUBJECT ACCOUNTABILITY .............................................................................................24 

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10.1. Point of Enrollment ...............................................................................................24 
10.2. Withdrawal ............................................................................................................25 
10.3. Subject Status and Classification .........................................................................25 
10.4. Enrollment Controls .............................................................................................26 
10.5. End-of-Study Action Plan ....................................................................................26 
11. STUDY METHODS .............................................................................................................26 
11.1. Data Collection ......................................................................................................26 
11.2. Study Candidate Screening ..................................................................................28 
11.2.1. Informed Consent .....................................................................................28 
11.2.2. Screening Period .......................................................................................28 
11.3. Opioid Medication Lock Visit (Up to 35 days following informed consent) ....28 
11.4. Baseline Period (14 days) ......................................................................................29 
11.5. Baseline Visit (0 – 7 days post Baseline Period) .................................................29 
11.6. Implant Procedures (Up to 90 days following the Baseline Visit) ....................29 
11.7. Healing Period (0 - 28 days following Implant Procedures) .............................30 
11.8. Activation Visit (Day 0) ........................................................................................30 
11.9. Programming Period (Up to 70 days following the Activation Visit) ...............30 
11.10. 
Programming Lock Visit (Day 70 + 14 days) .......................................30 
11.11. 
Evaluation Period ...................................................................................31 
11.12. 
3-Month Visit (90 + 14 days) ..................................................................31 
11.13. 
6-Month Visit (180 ± 30 days) ................................................................32 
11.14. 
9-Month Visit (270 ± 30 days) ................................................................33 
11.15. 
Year 1 Visit (365 ± 30 days) ...................................................................34 
11.16. 
Unscheduled Visit ...................................................................................35 
11.16.1. Revision or Replacement of Leads, Extensions and/or IPGs ...................35 
11.16.2. Interventional Pain Procedures .................................................................35 
11.17. 
Medication Requirements ......................................................................36 
11.18. 
Study Completion ...................................................................................36 
11.19. 
Source Documents ..................................................................................36 
12. STATISTICAL CONSIDERATIONS ......................................................................................37 
12.1. Endpoints ...............................................................................................................37 
12.1.1. Primary Endpoint ......................................................................................37 

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12.1.1.1. Hypotheses ...............................................................................37 
12.1.1.2. Sample Size ..............................................................................37 
12.1.1.3. Statistical Methods ...................................................................38 
12.1.2. Efficacy Endpoints ....................................................................................38 
12.1.3. Exploratory Endpoints ..............................................................................38 
12.2. General Statistical Methods .................................................................................38 
12.2.1. Analysis Sets .............................................................................................38 
12.2.2. Control of Systematic Error/Bias ..............................................................39 
12.2.3. Number of Subjects per Investigative Site ...............................................39 
12.3. Data Analyses ........................................................................................................39 
12.3.1. Interim Analyses .......................................................................................39 
12.3.2. Subgroup Analyses ...................................................................................39 
12.3.3. Justification of Pooling .............................................................................40 
12.3.4. Multivariable Analyses .............................................................................40 
12.3.5. Changes to Planned Analyses ...................................................................40 
13. DATA MANAGEMENT .......................................................................................................40 
13.1. Data Collection, Processing, and Review ............................................................40 
13.1.1. Electronic Questionnaires .........................................................................41 
13.1.2. Direct Data Upload ...................................................................................41 
13.2. Study Assessments .................................................................................................41 
13.2.1. Adverse Events .........................................................................................41 
13.2.2. Beck Depression Inventory (BDI-II) ........................................................41 
13.2.3. Concomitant Medications .........................................................................41 
13.2.4. Clinical Global Impression of Change (CGI-C) .......................................42 
13.2.5. Demography .............................................................................................42 
13.2.6. EQ-5D 5 Level (EQ-5D-5L) .....................................................................42 
13.2.7. Medical History ........................................................................................42 
13.2.8. Oswestry Disability Index Version 2.1a (ODI v2.1a) ..............................42 
13.2.9. Pain Intensity: NRS ..................................................................................42 
13.2.10. Pain Intensity: VRS ..................................................................................43 
13.2.11. Procedure Information ..............................................................................43 
13.2.12. Patient Global Impression of Change (PGI-C) .........................................43 
13.2.13. Percent Pain Relief (PPR) .........................................................................43 
13.2.14. Preference Questionnaire ..........................................................................43 
13.2.15. Programming Parameters ..........................................................................43 
13.2.16. Resource Utilization Inventory (RUI) ......................................................43 

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13.2.17. Short-Form Health Survey 36 Item (SF-36v2) .........................................44 
13.2.18. Therapy Rating .........................................................................................44 
13.2.19. Treatment Satisfaction Questionnaire for Medication – modified (TSQM-
9m) ............................................................................................................44 
13.2.20. Work Productivity (WPAI-SHP v2.0) ......................................................44 
13.3. Data Retention .......................................................................................................44 
14. AMENDMENTS ..................................................................................................................45 
15. DEVIATIONS .....................................................................................................................45 
16. DEVICE/EQUIPMENT ACCOUNTABILITY .........................................................................45 
17. COMPLIANCE ....................................................................................................................46 
17.1. Statement of Compliance ......................................................................................46 
17.2. Investigator Responsibilities ................................................................................46 
17.2.1. Delegation of Responsibility ....................................................................48 
17.3. Institutional Review Board ..................................................................................48 
17.4. Sponsor Responsibilities .......................................................................................48 
17.4.1. Role of Boston Scientific Representatives ...............................................49 
18. MONITORING ....................................................................................................................50 
19. POTENTIAL RISKS AND BENEFITS ...................................................................................50 
19.1. Anticipated Adverse Events .................................................................................50 
19.2. Anticipated Adverse Device Effects .....................................................................51 
19.3. Risks Associated with the Study Device(s) ..........................................................53 
19.4. Risks associated with Participation in the Clinical Study .................................53 
19.5. Possible Interactions with Concomitant Medical Treatments ..........................53 
19.6. Risk Minimization Actions ...................................................................................54 
19.7. Anticipated Benefits ..............................................................................................54 
19.8. Risk to Benefit Rationale ......................................................................................54 
20. SAFETY REPORTING .........................................................................................................55 
20.1. Reportable Events by investigational site to Boston Scientific .........................55 
20.2. Definitions and Classification ..............................................................................55 
20.3. Relationship to Study Device(s) ...........................................................................58 
20.4. Investigator Reporting Requirements .................................................................59 

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20.5. Boston Scientific Device Deficiencies ...................................................................60 
20.6. Reporting to Regulatory Authorities / IRBs / Investigators..............................61 
21. INFORMED CONSENT ........................................................................................................61 
22. SUSPENSION OR TERMINATION ........................................................................................62 
23.1 Premature Termination of the Study ..................................................................62 
23.1.1 
Criteria for Premature Termination of the Study ......................................62 
23.2 Termination of Study Participation by the Investigator or Withdrawal of IRB 
Approval ................................................................................................................63 
23.3 Requirements for Documentation and Subject Follow-up ................................63 
23.4 Criteria for Suspending/Terminating a Study Site ............................................63 
23. PUBLICATION POLICY ......................................................................................................64 
24. BIBLIOGRAPHY .................................................................................................................64 
25. ABBREVIATIONS AND DEFINITIONS .................................................................................66 
25.1. Abbreviations ........................................................................................................66 
 
3.1. Table of Figures 
Figure 8.1-1: VERITAS Study Design ................................................................................... 21 
 
3.2. Table of Tables 
Table 9.2-1: Inclusion Criteria ............................................................................................. 22 
Table 9.3-1: Exclusion Criteria ............................................................................................ 23 
Table 11.1-1: Data Collection Schedule .............................................................................. 27 
Table 11.17-1: Source Documentation Requirements ............................................................ 36 
Table 20.2-1: Safety Definitions ............................................................................................. 55 
Table 20.3-1: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event .................................................................................................................... 58 
Table 20.4-1: Investigator Reporting Requirements ............................................................... 59 
Table 27.1-1: Abbreviations ................................................................................................... 66 
 

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4. Introduction 
4.1. Chronic Intractable Pain 
Chronic intractable pain is often defined as pain persisting for at least 6 months which has 
not responded to conservative treatment(s). The pain may be due to current or past nerve 
injury and causes significant disability, reduced work productivity, reduced quality of life, 
and significant cost burden.   
The complexity of chronic pain and the diverse population it affects have resulted in varying 
results between the various treatment approaches including medications, physical therapy, 
stimulation etc. Early treatments for chronic pain typically include over the counter and 
prescription medications. Later treatments like physical therapy and interventional pain 
procedures (e.g. intraspinal injections, vertebroplasty, pulsed RF) are attempted, sometimes 
followed by chronic high dose opioids and back surgery, if indicated. If back surgery is 
unsuccessful in relieving the chronic pain, the patient can be labeled as having failed back 
surgery syndrome (FBSS). Spinal cord stimulation (SCS) is an option in well-selected 
patients with chronic low back and/or leg pain.    
4.2. Spinal Cord Stimulation 
SCS is effective for chronic intractable pain associated with a variety of conditions, 
including, but not limited to, FBSS ((Carter et al., 2004, Taylor et al., 2004), complex 
regional pain syndrome (Sears et al., 2011), and low back pain and leg pain (Cameron et al., 
2004). Spinal cord stimulation (SCS) is a less invasive treatment option for FBSS but has 
generally been reserved for patients who have failed multiple, and indeed all possible, repeat 
operations. With SCS, an implanted pulse generator (IPG) delivers electrical current to 
electrode(s) implanted in the epidural space. This current stimulates nerves and can be 
programmed to direct stimulation to the nerves innervating the painful location, resulting in a 
reduction of the intensity of that pain (Kumar et al., 2006). Before an SCS system is 
implanted, a patient often undergoes a screening trial with an electrode that is connected to 
an external stimulator that the patient wears outside of the body. The results of the screening 
trial can predict the patient’s outcome with an implanted system (Kumar et al., 2006).  
In SCS pain relief is realized when the nerves that innervate the painful region(s) are 
electrically stimulated (North et al., 1990). To increase the chance of success, the electrode 
contacts are programmed based on the patient feedback to various combinations of contact 
polarities (anodes and cathodes), pulse rate (or frequency), pulse amplitude (or current), and 
pulse width. 
Traditionally, Spinal Cord Stimulation (SCS) has relied on the understanding that to achieve 
pain relief, dorsal column stimulation-induced paresthesia has to be generated around the 
area of pain in order to successfully treat pain (North et al. 1991). However, recent studies 
indicate that effective pain relief may be obtained by employing stimulation without 
paresthesia (Van Buyten et al., 2012, De Ridder et al., 2010, Kapural et al 2015).  

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5. Device Description 
The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the 
management of chronic intractable pain of the trunk and/or limbs, including unilateral or 
bilateral pain associated with the following: failed back surgery syndrome, Complex 
Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. 
The System includes an Implantable Pulse Generator (IPG), External Trial Stimulator (ETS), 
Remote Control (RC), External Charger, and Clinician’s Programmer (CP) and a portfolio of 
lead options. The IPG is rechargeable and is recharged transcutaneously by a charging unit. 
The System is capable of providing multiple waveforms.  
 
The Spectra WaveWriter SCS System is approved by the Food and Drug Administration 
(FDA) and will be used per approved Directions for Use (DFU) in this study.    
6. Study Objectives  
6.1. Primary Objective 
The primary objective of this study is to demonstrate the value of multiple modalities and 
sustained clinically significant pain relief in patients with chronic pain when using the 
Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) System. 
6.2. Secondary Objective 
The secondary objective of this study is to determine the impact of Spectra WaveWriter SCS 
System on global patient outcomes including quality of life, patient preference, etc.   
7. Study Endpoints  
7.1. Primary Endpoint 
The primary endpoint is the proportion of subjects with 50% or greater reduction from the 
Baseline Visit in average overall pain intensity at 3 months post activation, with no increase 
in baseline average daily opioid medications used to treat pain. 
7.2. Secondary Endpoints 
The following secondary endpoints will be evaluated. Assessments required for deriving each 
endpoint are denoted in parentheses. 
• Change in overall pain intensity from Baseline Visit to 3 months post activation Visit 
(VRS)  
• Percent Pain Relief (PPR) in overall pain at 3 months post activation Visit (PPR) 

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• Patient global impression of change at 3 months post activation Visit (PGI-C) 
• Clinician global impression of change at 3 months post activation Visit (CGI-C) 
• Treatment Satisfaction at 3 months post activation Visit (TSQM-9m) 
• Change in disability from Baseline Visit to 3 months post activation Visit (ODIv2.1a) 
7.3. Exploratory Endpoints 
The following exploratory endpoints will be evaluated. Assessments required for deriving 
each endpoint are denoted in parentheses. 
• Number of patient preferred modalities at 6 months, 9 months and Year 1 post 
activation Visit (Preference Questionnaire) 
• Satisfaction with each modality at 3 months, 6 months, 9 months and Year 1 post 
activation Visits (Patient Remote Control) 
• Change in average overall pain intensity from Baseline Visit to 6 months, 9 months 
and Year 1 post activation Visits (VRS) 
• Change in average low back pain intensity from Baseline Visit to 3 months, 6 months, 
9 months and Year 1 post activation Visits (VRS) 
• Change in average leg pain intensity from Baseline Visit to 3 months, 6 months, 9 
months and Year 1 post activation Visits (VRS) 
• Change in average overall pain intensity from Baseline Visit to 3 months, 6 months, 9 
months and Year 1 post activation Visits (NRS) 
• Change in average low back pain intensity from Baseline Visit to 3 months, 6 months, 
9 months and Year 1 post activation Visits (NRS) 
• Change in average leg pain intensity from Baseline Visit to 3 months, 6 months, 9 
months and Year 1 post activation Visits (NRS) 
• Percent pain relief of overall pain at 6 months, 9 months and Year 1 post activation 
Visits (PPR) 
• Percent pain relief of low back pain at 3 months, 6 months, 9 months and Year 1 post 
activation Visits (PPR) 
• Percent pain relief of leg pain at 3 months, 6 months, 9 months and Year 1 post 
activation Visits (PPR) 
• Clinician global impression of change at 6 months, 9 months and Year 1 post 
activation Visits (CGI-C) 
• Patient global impression of change at 6 months, 9 months and Year 1 post activation 
Visits (PGI-C) 
• Treatment satisfaction at 3 months, 6 months, 9 months and Year 1 post activation 
Visits (TSQM-9m) 

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• Change in quality of life from Baseline Visit to 3 months, 6 months, 9 months and 
Year 1 post activation Visits (SF-36v2) 
• Change in disability from Baseline Visit to 6 months, 9 months and Year 1 post 
activation Visits (ODIv2.1a) 
7.4. Health Economic Endpoints 
The following Health Economic Endpoints will be included in this study. Assessments 
required for deriving each endpoint are noted in parentheses. 
• Economic value at Year 1 post activation (RUI, EQ-5D-5L, Concomitant Medications, 
Procedure Information) 
• Change in work-related productivity from Baseline to Year 1 post activation (WPAI-SHP 
v2.0) 
• Change in Quality of life from Baseline Visit to 3 months, 6 months, 9 months, Year 1 
post activation (EQ-5D-5L) 
7.5. Primary Safety Parameters 
Safety parameters include the rates of occurrence of all device and procedure related non-
serious adverse events, all serious adverse events, and unanticipated adverse events through 
the end of the study. 
8. Study Design 
The study is a prospective, multi-center, single-arm open-label study with an adaptive design. 
All participants will receive the Spectra WaveWriter Spinal Cord Stimulator (SCS) system 
and followed per the study schedule as shown in study schematic Figure 8.1-1.  
8.1. Scale and Duration 
The study will activate up to 64 subjects at up to 20 investigational sites in the United States. 
Enrollment is expected to take approximately 15 months and a subject’s participation in the 
study, from the point of enrollment until study completion, should last approximately 16 
months.   
The study is expected to last approximately 34 months from the first patient enrolled until the 
end of study close-out activities.    
 

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Figure 8.1-1: VERITAS Study Design 
 
8.1.1. Treatment  
All enrolled subjects who pass eligibility criteria will receive a trial. Subjects with a positive 
trial will proceed to receive permanent implant. Following permanent implant, all subjects’ 
device will be activated to provide therapy. 
8.2. Justification for the Study Design 
The study is a prospective, multi-center, open-label study with an adaptive design. The study 
is designed to demonstrate the value of multiple modalities and sustained clinically 
significant pain relief in patients with chronic pain when using the Boston Scientific Spectra 
WaveWriter SCS System. Additionally, the impact of the Spectra WaveWriter SCS System 
on global patient outcomes, quality of life and patient preference will also be evaluated.  
A prospective study design will eliminate the bias associated with case selection in a 
retrospective review and will ensure that identical procedures are followed for data capture 
and review.  
A multi-center design will minimize the impact on treatment outcome that may potentially 
result from differences in patient selection, regional differences in the patient demographic, 
and differences in investigator technique and patient management.   

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The primary endpoint is the proportion of subjects with 50% or greater reduction (responder 
rate) from the Baseline Visit in average overall pain intensity at 3 months post activation, 
with no increase in baseline average daily opioid medications used to treat pain. A 3 month 
endpoint was chosen as 3 months provides adequate time for a subject to have their 
programming parameters optimized.  
9. Subject Selection  
9.1. Study Population and Eligibility  
Study candidates will be drawn from the population of patients resident in pain management 
or surgical medical practices.  The study eligibility criteria are listed in Sections 9.2 and 9.3.  
9.2. Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 9.2-1) may be given consideration 
for inclusion in this clinical investigation, provided no exclusion criterion (see Section 9.3) is 
met.  
Table 9.2-1: Inclusion Criteria 
Clinical 
Inclusion 
Criteria 
IC1. Chronic pain of the trunk and/or limbs for at least 6 months  
IC2. No back surgery within 6 months prior to Screening 
IC3. Average overall pain intensity (leg and/or low back pain) of 6 or 
greater on a 0-10 numerical rating scale at Baseline Visit based on 
7-day recall 
IC4. If taking prescription opioids  for primary chronic pain complaint 
(low back and/or leg pain), must have been on a stable prescription 
(same drug(s) and dose(s)) 30 days prior to Screening 
IC5. Consumed an average total daily morphine equivalent of ≤200 mg 
during the 30 days prior to Screening 
IC6. Willing and able to comply with all protocol-required procedures 
and assessments/evaluations  
IC7. Baseline Oswestry Disability Index (ODI) score ≥40 and ≤80 
IC8. 22 years of age or older when written informed consent is 
obtained  
IC9. Eligible candidate for SCS from a psychological and psychiatric 
standpoint as determined within 180 days prior to Baseline Visit, 
per site’s routine screening process  
IC10. Able to independently read and complete all questionnaires and 
assessments provided in English 

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IC11. If female of childbearing potential: not pregnant, as evidenced by a 
negative pregnancy test at Screening 
IC12. Subject signed a valid, IRB-approved informed consent form (ICF) 
provided in English 
Abbreviations: Spinal Cord Stimulation (SCS), Directions for Use (DFU), Milligram (mg), Institutional Review 
Board (IRB), Informed Consent Form (ICF) 
9.3. Exclusion Criteria 
Subjects who meet any one of the following criteria (Table 9.3-1) will be excluded from this 
clinical study. 
Table 9.3-1: Exclusion Criteria 
Clinical 
Exclusion 
Criteria 
EC1. Average leg pain intensity is greater than average low back pain 
intensity as reported during Baseline Period 
EC2. Patient exhibits catastrophization based on physician evaluation 
(e.g., average overall daily pain intensity of 10 on a 0-10 
numerical rating scale, every day during the 7 days prior to 
Screening, based on patient recall) 
EC3. Radiographic evidence of spinal instability requiring fusion 
EC4. Primary pain complaint of vascular origin (e.g. peripheral 
vascular disease) 
EC5. Spinal pain secondary to neoplasm, infection, autoimmune 
disorder with spinal involvement, or a spinal metabolic disorder  
EC6. Visceral pain referred to the low back and/or legs 
EC7. Any pain-related diagnosis or medical/psychological condition 
that, in the clinician’s best judgment, might confound reporting 
of study outcomes (e.g. pelvic pain, anginal pain, chronic 
migraine, brain or spinal cord tumor) 
EC8. Require implantation of lead(s) in the cervical epidural space 
EC9. Current systemic infection, or local infection in close proximity 
to anticipated surgical field, at Screening 
EC10. High surgical risk 
EC11. Body mass index ≥ 45 at Screening 
EC12. Terminal illness with anticipated survival < 12 months 
EC13. Current condition associated with risk of immunocompromise 
that might increase risk of infection during study duration  

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EC14. Currently on any anticoagulant medications that cannot be 
discontinued during perioperative period 
EC15. Significant cognitive impairment at Screening that, in the 
opinion of the Investigator, would reasonably be expected to 
impair the study candidate’s ability to participate in the study 
EC16. Participating (or intends to participate) in another drug or device 
clinical trial that may influence the data that will be collected for 
this study 
EC17. Previous spinal cord stimulation trial or is already implanted 
with an active implantable device(s) (e.g. pacemaker, drug 
pump, implantable pulse generator) 
EC18. A female who is breastfeeding 
EC19. A female of childbearing potential planning to get pregnant 
during the course of the study or not using adequate 
contraception  
EC20. Plan to receive any massage or manipulation directly over the 
leads or by the anticipated location of the IPG or treatments that 
involve sudden jerking motions of the torso at any time during 
the course of the study 
EC21. A condition currently requiring or likely to require the use of 
MRI or diathermy 
EC22. Any injury or medical/psychological condition that might be 
significantly exacerbated by the implant surgery or the presence 
of an implantable stimulator or otherwise compromise subject 
safety 
EC23. Unable to operate the study device 
Abbreviations: Implantable Pulse Generator (IPG), Magnetic Resonance Imaging (MRI). 
10. Subject Accountability 
10.1. Point of Enrollment 
A subject will be considered enrolled in the study when the Informed Consent Form (ICF) is 
signed. All enrolled and activated subjects will be included in the study analyses. 
If device implantation is unsuccessful, the subject will be followed for 2 weeks post 
implantation attempt to assess for procedure related adverse events.   

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10.2. Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) shall be accounted for and documented. If a subject withdraws from the 
clinical investigation, the reason(s) shall be reported. If such withdrawal is due to problems 
related to investigational device safety or performance, the investigator shall ask for the 
subject’s permission to follow his/her status/condition outside of the clinical study.   
While study withdrawal is discouraged, subjects may withdraw from the study at any time, 
with or without reason and without prejudice to further treatment. In all cases of withdrawal 
or discontinuation, the Investigator will make all reasonable efforts to determine the reason 
for the subject’s withdrawal. Subjects may be discontinued from the study for the various 
reasons, such as: 
• 
Withdrawal of consent 
• 
A safety concern defined by the Principal Investigator and/or Boston Scientific 
Neuromodulation (e.g., adverse event) 
• 
Study non-compliance 
• 
Inadequate use of device that may impact study outcomes Subject did not meet 
inclusion criteria or met an exclusion criterion after signing informed consent 
• 
Surgical intervention that affects the Implantable Pulse Generator (IPG) and/or leads 
• 
Lost to follow-up 
• 
Death of the subject 
A subject is considered lost-to-follow-up after 3 unsuccessful contact attempts have been 
made to reach the subject (including those who relocate but cannot be transferred to another 
participating site). Staff at the participating site should make a good faith effort to contact the 
subject with three documented communication attempts, at least one of which must be in 
writing, sent via a traceable method to inform the subject that the device must programmed 
per standard of care with commercially approved settings.  
Data collected up to the point of subject withdrawal or lost to follow-up may be used for 
study analysis in accordance with applicable regulations.  
Withdrawn subjects will be followed per the End of Study Action Plan as described in 
Section 10.5.  
10.3. Subject Status and Classification 
Subjects who provide written informed consent but do not meet all of the study eligibility 
criteria will not be implanted or activated. These subjects will be deemed as “enrolled but not 
activated” and their reason for ineligibility will be documented.  
Enrolled subjects who are not activated will not count towards the enrollment cap. Subjects 
who sign consent, meet all eligibility criteria, undergo permanent implant and are activated 
cannot be replaced.  

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10.4. Enrollment Controls 
The overall enrollment in the study will be capped at 64 activated subjects. Per site 
enrollment will be capped initially at 10 activated subjects. The initial cap of 10 activated 
subjects at any one site can be increased based upon written communication of sponsor 
approval. 
The study will implement a formal Enrollment Communication Plan. The plan will outline 
the specific activities, as well as the nature and timing of communications to investigators in 
order to minimize the risk of enrollment beyond the protocol-specified enrollment caps 
determined by the statistical analysis plan. 
10.5. End-of-Study Action Plan 
When each subject completes the 1-Year Visit or withdraws, the subject exits the study and 
ends study participation. Subjects may continue to use their system per the applicable 
Directions for Use and will be followed according to standard of care.   
If the study is terminated early due to sponsor discretion or due to the discovery of an 
unexpected, significant, or unacceptable risk/safety concern regardless of how far along the 
subject has reached in their study follow-up, subjects will be followed according to standard 
of care. Sites will have 30 days to notify all subjects of study closure.  
If device implantation is unsuccessful, the subject will be followed for 2 weeks post 
implantation attempt to assess for procedure related adverse events. If the device is 
explanted, the subject will be followed for 30 days post explant to assess for related adverse 
events.   
Device related adverse events and/or deficiencies occurring after study participation, 
withdrawal from the study, or after the specified timeframe following unsuccessful trials, 
implant failures, and explants, should be reported to BSN Patient Care at: 866-360-4747. 
Such complications should not be captured as adverse events in the study.  
11. Study Methods 
11.1. Data Collection 
There are a number of different study assessments required at each visit. The data collection 
schedule is provided in Table 11-1. Full descriptions for all assessments are provided in 
Section 13. 
 
 
 
 

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     Table 11.1-1: Data Collection Schedule 
  
Screening 
Opioid 
Medication   
Lock Visit 
Baseline 
Period  
Baseline 
Visit  
Implant 
Procedures  
(Trial and 
Permanent) 
Healing Period (0-28 days) 
Activation 
Visit  
Programming 
Period 
Programming 
Lock Visit 
Evaluation 
Period 
3-Month 
Visit  
6-Month 
Visit 
9-Month 
Visit 
1-Year 
Visit 
 
End of 
Study  
Unscheduled 
Visit 
  
Up to 35 
days  
14 days 
post-
Medication 
Lock 
  
Up to 90 
days post-
Baseline 
Visit 
Day 0 
Up to 70 days 
post-
Activation 
Visit 
70  ± 14 days 
90 +  14 
days 
180 ± 30 
days 
270 ± 30 
days 
365 ± 30 
days 
  
Informed Consent (ICF) 
X 
  
  
  
  
  
  
  
  
  
  
  
  
  
Inclusion/Exclusion Criteria 
Evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demography 
  
  
  
X 
  
  
  
  
  
  
  
  
  
  
Medical History 
  
  
  
X 
  
  
  
  
  
  
  
  
  
  
Beck Depression Inventory 
(BDI-II) 
 
 
 
X 
 
 
 
 
 
X 
 
 
X 
 
Oswestry Disability Index 
(ODI v2.1a) 
  
  
  
X 
  
  
  
  
  
X 
X 
X 
X 
  
Short Form Health Survey 
36 item (SF-36v2) 
  
  
  
X 
  
  
  
  
  
X 
X 
X 
X 
  
EQ-5D-5L 
 
 
 
X 
 
 
 
 
 
X 
X 
X 
X 
 
Resource Utilization 
Inventory (RUI) 
 
 
 
X 
 
 
 
 
 
X 
X 
X 
X 
 
Work Productivity (WPAI-
SHP v2.0) 
 
 
 
X 
 
 
 
 
 
X 
X 
X 
X 
 
Pain Intensity (NRS) 
 
 
 
X 
 
 
 
 
 
X 
X 
X 
X 
 
Pain Intensity (VRS) 
 
 
 
X 
 
 
 
 
 
X 
X 
X 
X 
 
Procedure Information 
  
  
  
  
X₸ 
  
  
  
  
  
  
  
  
X** 
End of Trial Assessment 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Programming 
Parameters*** 
  
  
  
  
 X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Therapy Rating 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Clinician Global Impression 
of Change (CGI-C) 
  
  
  
  
  
  
  
  
  
X 
X 
X 
X 
  
Patient Global Impression of 
Change (PGI-C) 
  
  
  
  
  
  
  
  
  
X 
X 
X 
X 
  
Percent Pain Relief (PPR) 
  
  
  
  
  
  
  
  
  
X 
X 
X 
X 
  
Preference Questionnaire 
  
  
  
  
  
  
  
 
 
X 
X 
X 
X 
  
Treatment Satisfaction 
Questionnaire (TSQM-9m) 
  
  
  
  
  
  
  
  
  
X 
X 
X 
X 
  
Concomitant Medications  
(opioid pain medications) 
  
X 
  
X 
X 
X 
  
 X 
  
X 
X 
X 
X 
X 
Adverse Event (AE) 
X¥ 
X¥ 
X¥ 
X¥ 
X¥ 
X¥ 
X¥ 
X¥ 
X¥ 
X¥ 
X¥ 
X¥ 
X¥ 
X¥ 
  
  
  
  
  
Opioid Medications Locked 
  
  
  
  
  
**For unscheduled visits where procedures are performed. 
***Only when device programming is performed. 
₸ The device will remain off until the Activation Visit. 
¥ A follow up neurological assessment may be performed to determine if neurological deficit is noted.  
  
  
  
  
  
  

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11.2. Study Candidate Screening  
Subjects’ eligibility for the study will be assessed based on study Inclusion and Exclusion 
criteria listed in Sections 9.2 and 9.3, respectively. Subjects who have provided informed 
consent and who have been determined to not meet all eligibility requirements will be 
withdrawn. 
11.2.1. Informed Consent 
Written Informed Consent must be obtained for all patients who are potential study 
candidates.  Study candidates will be asked to sign the Informed Consent form before any 
study-specific tests or procedures are performed.   
• The context of the study must be fully explained to the patient and patients 
must be given an opportunity to ask questions and have those questions 
answered to their satisfaction.   
• Study personnel should explain to each potential participant that even if he or 
she agrees to participate in the study and signs an informed consent form, 
further testing might demonstrate that he or she is not eligible for the study.   
• Written informed consent must be recorded appropriately by means of the 
subject’s dated signature.   
• The consent process must be documented in the subject’s medical chart. 
Research study candidates in the State of California will also be provided with the California 
Experimental Patient’s Bill of Rights 
11.2.2. Screening Period  
Subjects undergo screening related procedures to determine eligibility for the study. It may 
take up to the end of Baseline Period to complete all eligibility requirements. 
All enrolled subjects who are women of child-bearing potential must undergo a pregnancy 
test at screening. Women with positive pregnancy test results will be withdrawn from the 
study. The results of the test result must be documented in the subject’s medical chart.  
Subjects taking prescription opioids for primary chronic pain complaint (low back and/or leg 
pain), whose pain medications are not stable for 30 days prior to informed consent, will be 
withdrawn. However these subjects may be re-consented/rescreened once 30 days have 
passed since the last change.  
Any adverse event occurring after the subject is enrolled (i.e. signing the Informed Consent 
Form) will be documented.  
11.3. Opioid Medication Lock Visit (Up to 35 days following informed consent) 
The in-office Opioid Medication Lock Visit will occur within 35 days following informed 
consent, after completion of some screening requirements as described in Section 11.2. At 
this visit, the subject’s opioid pain medications will be locked, with no change in 
type/dose/route/frequency, until the 3-Month post-Activation Visit.  

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At this visit (or during the screening period), the investigator will convert the subject’s opioid 
medication prescriptions from PRN to a fixed dose, as needed.  
11.4. Baseline Period (14 days) 
The Baseline Period will last for 14 consecutive days following the Medication Lock Visit. 
At the end of the Baseline Period, subjects will return to the clinic for their Baseline Visit.  
Subjects are to not make any changes to their opioid pain medications during this period.  
11.5. Baseline Visit (0 – 7 days post Baseline Period)  
At the Baseline Visit, subjects will return to the clinic to complete all screening requirements. 
Any adverse since the last study visit will be collected.  
The following assessments, as outlined in Table 11.1-1, will be conducted: 
• Demographics 
• Medical history  
• Beck Depression Inventory (BDI-II) 
• Oswestry Disability Index (ODIv2.1a) 
• Short Form Health Survey 36 (SF-36v2) 
• EQ-5D 5-Level 
• Resource Utilization Inventory (RUI) 
• Work Productivity (WPAI-SHP v2.0) 
• Pain Intensity: VRS 
• Pain Intensity: NRS 
Subjects that meet all study criteria will be scheduled for the device implant procedures (trial 
and permanent implant of the SCS system). If a subject fails to meet all the eligibility criteria, 
they will be withdrawn from the study. 
End of Visit Information: 
• Subjects should be reminded not to make any changes to their opioid medications. 
11.6. Implant Procedures (Up to 90 days following the Baseline Visit) 
Subjects will have up to 90 days following the Baseline Visit to receive their Spectra 
WaveWriter System. Subjects will undergo a trial procedure per standard of care. Following 
a successful trial, i.e. at least 50% pain reduction in their overall pain as compared with 
Baseline, the subject will proceed to permanent implantation. Subjects with an unsuccessful 
implant procedure will be followed for 2 weeks for procedure related adverse events then 
withdrawn from the study. Acute opioid pain medications may be taken. 

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11.7. Healing Period (0 - 28 days following Implant Procedures) 
The subject’s device will remain inactivated (device OFF) for up to 28 days following the 
permanent implantation procedure to allow for healing. Acute opioid pain medications may 
be taken during this period. No additional scheduled assessments will be completed during 
this period.  
11.8. Activation Visit (Day 0) 
At the Activation Visit, the subject’s Spectra WaveWriter SCS System will be activated. Any 
adverse events since the last study visit will be collected.  
Subjects must stop taking acute opioid pain medications, as applicable, and are not to make 
any changes to their opioid pain medications up to the 3-Month Visit.  
Information regarding programming parameters will be documented. To aid in programming 
it is recommended that thoracic and/or lumbar imaging is obtained at this visit or up to 7 days 
prior to the visit to show the position(s) of the study device lead(s). In the event of suspected 
lead migration, imaging may be performed to document lead positions. 
End of Visit Information:  
• Subjects will receive instructions on the use of the device including the Remote 
Control and charging system. 
• Subjects should be instructed to evaluate all programs saved on the Remote 
Control prior to their next visit as applicable.   
• Subjects are to contact the site in an event that any additional intervention is 
warranted, to report a complaint and/or a suspected adverse event, 
reprogramming, etc. 
• Subjects should be reminded not to make any changes to their opioid pain 
medications.  
11.9. Programming Period (Up to 70 days following the Activation Visit) 
Following device activation, subjects’ device will be optimized to achieve effective therapy 
during the Programming Period of up to 70 days post-activation.  
During this period, subjects may return as many times as needed (unscheduled visits) for 
optimization of programming.  
Information regarding programming parameters and device information may be collected and 
documented. 
11.10. 
Programming Lock Visit (Day 70 + 14 days) 
At the Programming Lock Visit, subjects will return to the clinic to have their programs 
locked. Any adverse events since the last study visit will be collected.  

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It is recommended that their final settings be documented in the study records. No further 
changes to the subjects programs such as electrode configuration will be allowed except to 
resolve a device and/or stimulation-related AE.  
At this Visit, subjects will choose their preferred programs (or modalities) to be evaluated 
during the Evaluation Period. Subjects’ choice will be documented.   
Information regarding programming parameters and device information may be collected and 
documented. 
End of Visit Information:  
• Subjects will receive instructions on the use of the device including the Remote 
Control and charging system, as needed.  
• Subjects should be instructed to evaluate their preferred programs (or modalities) 
prior to their next visit.   
• Subjects are to contact the site in an event that any additional intervention is 
warranted, to report a complaint and/or a suspected adverse event, 
reprogramming, etc. 
• Subjects should be reminded not to make any changes to their opioid medications. 
11.11. 
Evaluation Period  
During the Evaluation Period, subjects will evaluate each of the programs (or modalities) 
previously chosen at the Programming Lock Visit.    
11.12. 
3-Month Visit (90 + 14 days)  
During the 3-Month Visit, subjects will return to the clinic for study evaluations and 
programming. Any adverse events since their last study visit will be collected.  
The following assessments will be completed as summarized in Table 11.1-1: 
• Beck Depression Inventory (BDI-II) 
• Oswestry Disability Index version 2.1a (ODI v2.1a) 
• Short Form Health Survey 36 items (SF-36 v2) 
• EQ-5D 5-Level 
• Resource Utilization Inventory (RUI) 
• Work Productivity (WPAI-SHP v2.0) 
• Pain Intensity: VRS 
• Pain Intensity: NRS 
• Clinical Global Impression of Change (CGI-C) 
• Patient Global Impression of Change (PGI-C)  
• Percent Pain Relief (PPR) 

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• Preference Questionnaire 
• Treatment Satisfaction Questionnaire for Medication - modified (TSQM-9m) 
Following completion of assessments, subjects’ device will be programmed as needed and 
programming information may be collected. 
• In the event of suspected lead migration or to aid programming the subject’s device, 
imaging may be performed to document lead position. 
• Any additional instructions related to charging of the device and/or use of Remote 
Control may be provided. 
End of Visit Information:  
• Subjects will receive instructions on the use of the device including the Remote 
Control and charging system, as needed.  
• Subjects are to contact the site in an event that any additional intervention is 
warranted, to report a complaint and/or a suspected adverse event, 
reprogramming, etc. 
• Changes to opioid pain medications are allowed up to End of Study Visit. 
11.13. 
6-Month Visit (180 ± 30 days)  
During the 6-Month Visit, subjects will return to the clinic for study evaluations and 
programming. Any adverse events since their last study visit will be collected.  
The following assessments will be completed as summarized in Table 11.1-1: 
• Oswestry Disability Index version 2.1a (ODI v2.1a) 
• Short Form Health Survey 36 items (SF-36 v2) 
• EQ-5D 5-Level 
• Resource Utilization Inventory (RUI) 
• Work Productivity (WPAI-SHP v2.0) 
• Pain Intensity: NRS 
• Pain Intensity: VRS 
• Clinical Global Impression of Change (CGI-C) 
• Patient Global Impression of Change (PGI-C)  
• Percent Pain Relief (PPR) 
• Preference Questionnaire 
• Treatment Satisfaction Questionnaire for Medication - modified (TSQM-9m) 
Following completion of assessments, subjects’ device will be programmed as needed and 
programming information may be collected. 

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• In the event of suspected lead migration or to aid programming the subject’s device, 
imaging may be performed to document lead position. 
• Any additional instructions related to charging of the device and/or use of Remote 
Control may be provided. 
End of Visit Information:  
• Subjects will receive instructions on the use of the device including the Remote 
Control and charging system, as needed.  
• Subjects are to contact the site in an event that any additional intervention is 
warranted, to report a complaint and/or a suspected adverse event, 
reprogramming, etc. 
• Changes to opioid pain medications are allowed up to End of Study Visit. 
11.14. 
9-Month Visit (270 ± 30 days)  
During the 9-Month Visit, subjects will return to the clinic for study evaluations and 
programming. Any adverse events since their last study visit will be collected.  
The following assessments will be completed as summarized in Table 11.1-1: 
• Oswestry Disability Index version 2.1a (ODI v2.1a) 
• Short Form Health Survey 36 items (SF-36 v2) 
• EQ-5D 5-Level 
• Resource Utilization Inventory (RUI) 
• Work Productivity (WPAI-SHP v2.0) 
• Pain Intensity: NRS 
• Pain Intensity: VRS 
• Clinical Global Impression of Change (CGI-C) 
• Patient Global Impression of Change (PGI-C)  
• Percent Pain Relief (PPR) 
• Preference Questionnaire 
• Treatment Satisfaction Questionnaire for Medication - modified (TSQM-9m) 
Following completion of assessments, subjects’ device will be programmed as needed and 
programming information may be collected.  
• In the event of suspected lead migration or to aid programming the subject’s device, 
imaging may be performed to document lead position. 
• Any additional instructions related to charging of the device and/or use of Remote 
Control may be provided. 
 

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End of Visit Information:  
• Subjects will receive instructions on the use of the device including the Remote 
Control and charging system, as needed.  
• Subjects are to contact the site in an event that any additional intervention is 
warranted, to report a complaint and/or a suspected adverse event, 
reprogramming, etc. 
11.15. 
Year 1 Visit (365 ± 30 days)  
During the 1 Year Visit, subjects will return to the clinic for study evaluations and 
programming. Any adverse events since their last study visit will be collected.  
The following assessments will be completed as summarized in Table 11.1-1: 
• Beck Depression Inventory (BDI-II) 
• Oswestry Disability Index version 2.1a (ODI v2.1a) 
• Short Form Health Survey 36 items (SF-36 v2) 
• EQ-5D 5-Level 
• Resource Utilization Inventory (RUI) 
• Work Productivity (WPAI-SHP v2.0) 
• Pain Intensity: NRS 
• Pain Intensity: VRS 
• Clinical Global Impression of Change (CGI-C) 
• Patient Global Impression of Change (PGI-C)  
• Percent Pain Relief (PPR) 
• Preference Questionnaire 
• Treatment Satisfaction Questionnaire for Medication - modified (TSQM-9m) 
Following completion of assessments, subjects’ device will be programmed as needed and 
programming information may be collected. 
• In the event of suspected lead migration or to aid programming the subject’s device, 
imaging may be performed to document lead position. 
• Any additional instructions related to charging of the device and/or use of Remote 
Control may be provided. 
The 1 Year Visit is the End of Study Visit and End of Study Action Plan (ESAP) will be 
followed as described in Section 10.5.  

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11.16. 
Unscheduled Visit 
Subjects may have as many unscheduled visits as required for device-related in-office or 
procedure visits (e.g., optimization of programming during the programming period) or for 
evaluation of possible adverse events and if applicable, re-positioning, replacement or 
explant of a device component. Unscheduled visit information will be captured, as 
applicable. 
11.16.1. Revision or Replacement of Leads, Extensions and/or IPGs 
During the course of the study, it is possible that leads may be placed incorrectly, migrate, or 
malfunction and require repositioning or replacement. It is also possible that the extensions 
or splitters or IPG may be uncomfortable or malfunction and may require repositioning or 
replacement. The decision to reposition or replace any device component will be made by the 
investigator and only if the subject agrees.  Subjects not agreeing to a recommended lead 
revision will be withdrawn from the study but will be included in the intent-to-treat and 
safety analyses. Subjects agreeing to revision will continue on study and will be followed 
according to the original study schedule. Effectiveness data from these subjects will be 
included in the intent to treat analysis. Lead revisions/replacements for the purpose of 
correcting for migration and/or malfunction must be performed as soon as is reasonably 
possible following determination of the need for revision/replacement.  
The investigator should notify Boston Scientific prior to any study procedures. Any 
replacements or revisions performed during the course of the study should be recorded in the 
EDC system, including information about the procedure, device, and/or adverse event if 
applicable.   
Information on assessing revisions or replacements of leads, extensions or IPGs as adverse 
events is described in Section 20. 
11.16.2. Interventional Pain Procedures 
No interventional pain procedures to treat the SCS-targeted pain are allowed through the 3-
Month Visit.  Procedures associated with the SCS device (e.g. IPG Revision, Lead revision, 
CSF leak interventions and interventions associated with SCS procedure related adverse 
event management) are allowed.  Excluded procedures include, but are not limited to, the 
following: 
•         Epidural steroid injection 
•         Facet joint injection 
•         Selective nerve root block 
•         Radiofrequency ablation 
•         Spine surgery (e.g., discectomy, vetebroplasty, fusion) 

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11.17. 
Medication Requirements 
Opioid Medication Lock Period (Medication Lock visit to 3-Month Visit):  
Investigators/Subjects will not be allowed to change opioid pain medications from the 
Medication Lock visit until completion of the 3-Month Visit. Type/dose/route must remain 
unchanged. 
The use of acute opioid pain medication for procedural discomfort is allowed during the 
Procedures and Healing Period and in the event of the revision or replacement of leads, 
extensions and/or IPG, per site’s routine care. 
Opioid Medication Open Period (3-Month Visit to End of Study visit) 
Investigators/Subjects may change opioid pain medications during the pain medication open 
period, from the 3-Month Visit to the 1-Year, End of Study Visit as needed.  
11.18. 
Study Completion 
All activated subjects permanently implanted will be followed through completion of the 1-
Year Visit or study withdrawal. The End of Study Action Plan (see Section 10.5) defines the 
actions to be taken when the subject reaches the end of their study participation.  
11.19. 
Source Documents 
Table 11.17-1 summarizes all source data requirements for this study. Any information first 
captured on an electronic data collection platform or within the EDC system on eCRF 
evaluations, assessments or questionnaires, not initially documented in another record, is 
considered the source documentation.  
Table 11.17-1: Source Documentation Requirements 
Requirement 
Disposition 
Hospital records and/or clinical and office charts 
including the evidence of but not limited to 
inclusion/exclusion criteria, informed consent, 
procedures, exams, SCS System procedure(s) 
and devices used, evaluations, health economic 
assessments, laboratory results, medications, 
assessment of adverse events. 
Retained at investigational site 
Assessments and questionnaires  
Retained at investigational site and/or 
electronic data collection platform/EDC 
Programming information 
Retained at investigational site and/or 
electronic data collection platform/EDC 
Imaging films/prints documenting lead(s) 
location  
Retained at investigational site 

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12. Statistical Considerations 
12.1. Endpoints 
12.1.1. Primary Endpoint 
The primary endpoint for this study is the proportion of subjects with 50% or greater 
reduction from Baseline Visit in average overall pain intensity at 3 months post activation 
with no increase in baseline average opioid medications used to treat pain. 
The percentage reduction of overall pain intensity will be assessed on a scale of 0-100% 
based on the Percent Pain Relief (PPR) questionnaire. Opioids will be calculated for each 
subject based on Concomitant Medications.   
Opioid prescription dose will be calculated as milligram morphine-equivalent (MME) based 
on the method described by McPherson (Mcpherson 2009).  
12.1.1.1. Hypotheses 
The primary statistical hypothesis in this study is that the proportion of subjects with 50% or 
greater reduction from Baseline Visit in average daily overall pain intensity at 3 months post 
activation is non-inferior to an Objective Performance Criteria (OPC) of 40%.   
H0:  πopc -  πt ≥ 0.20 
H1:  πopc -  πt < 0.20 
Where πt is the proportion of subjects with 50% or greater reduction from Baseline in 
average daily overall pain intensity at 3 months post activation with no increase in baseline 
average daily opioid pain medications using Spectra WaveWriter. πopc is the responder rate of 
an OPC based on Kumar paper (Kumar 2008).  
12.1.1.2. Sample Size  
The required sample size for this study was calculated based on the following assumptions: 
Test significance level (α) 
             0.025 
1 or 2 sided test                                        1 
Difference in Response (ε) 
0.00 
Non-inferiority margin (δ) 
             0.20 
OPC  
              
 
 
0.40 (Kumar et al) 
Power (1- β) 
                                       0.90 
N 
 
 
 
 
58 
Attrition (%) 
                                       10 
N 
                                                    64 

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Therefore, a total of 64 activated subjects are required.  
12.1.1.3. Statistical Methods 
The 95% confidence interval of πopc  -  πt will be computed. The study will be considered a 
success if, using the Intent-To-Treat (ITT) analysis, the upper bound of the two-sided 95% 
confidence interval for the difference is less than 0.20.   
For the primary endpoint, statistical testing will be performed to determine if the overall pain 
responder rate is superior to the OPC of this study.  
The statistical test will be a Fisher’s Exact test for a single proportion.  
12.1.2. Efficacy Endpoints 
The following secondary endpoints will be evaluated. Assessments required for deriving each 
endpoint are denoted in parentheses.  
• Change in overall pain intensity from Baseline Visit to 3 months post activation Visit 
(VRS).  
• Percent Pain Relief (PPR) in overall pain at 3 months post activation Visit (PPR) 
• Patient global impression of change at 3 months post activation Visit (PGI-C) 
• Clinician global impression of change at 3 months post activation Visit (CGI-C) 
• Treatment Satisfaction at 3 months post activation Visit (TSQM-9m) 
• Change in disability from Baseline Visit to 3 months post activation Visit (ODIv2.1a) 
12.1.3. Exploratory Endpoints 
A number of exploratory endpoints are included in this study to explore the effect of 
treatment on additional outcomes.  
The exploratory endpoints are intended to generate hypotheses for future studies. 
Consequently, no correction for multiple testing will be performed for the exploratory 
endpoints. All exploratory endpoints will be clearly identified as such in study reports. 
12.2. General Statistical Methods 
12.2.1. Analysis Sets 
• Intent-to-Treat (ITT) Population:  All subjects who receive the study device and are 
activated.   
• Per Protocol (PP) Population:  All subjects who receive the study device, with no major 
protocol deviations.  

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• Safety Population: All subjects who sign the IRB-approved written Informed Consent 
form  
12.2.2. Control of Systematic Error/Bias 
Selection of patients will be made from the Investigator's usual patient load. All patients 
meeting the inclusion/exclusion criteria and having signed the Informed Consent Form will 
be eligible for participation in the study. The reasons for exclusion, for subjects who sign an 
informed consent form but are not implanted, will be indicated in EDC. Boston Scientific 
will report to the ethic committee any evidence of fraud, including deliberate tampering with 
the selection of subjects. 
12.2.3. Number of Subjects per Investigative Site 
In order to enroll up to 64 subjects, up to 20 investigative sites will be included. The number 
of activated subjects at each site will capped at 10 subjects per site. The initial cap of 10 
activated subjects at any one site can be increased based upon written communication of 
sponsor approval. 
12.3. Data Analyses 
All statistical analyses will be done using the SAS System software, version 8.2 or later 
(Copyright © 2000 SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513, 
USA. All rights reserved). Additional details on these analyses can be found in the Statistical 
Analysis Plan. 
12.3.1. Interim Analyses  
This study will have a total of 3 looks, with two interim analyses at: 
• 18 activated subjects at 3-Month Visit: futility and effectiveness stopping45 activated 
subjects at 3-Month Visit: futility and effectiveness stopping 
The adaptive design will use the Lan-DeMets group sequential method (Lan and DeMets 
1983) with the O’Brien-Flemming α-spending function (O'Brien and Fleming 1979) and 
Pocock β-spending function (Pocock 1977). 
All interim analysis decision will proceed according to pre-specified decision rules, detailed 
in the Statistical Analysis Plan. 
12.3.2. Subgroup Analyses 
Results will be summarized for the following subgroups: 
• Opioid user (Yes/No) 
• Gender (male, female, intersex) 
• Number of back surgeries (0 vs. 1 or more) 

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• Primary Pain Diagnosis 
• Study region or center 
• Severity of pain score at Baseline (> 7, < 7) 
12.3.3. Justification of Pooling 
Analyses will be performed using data pooled across various sites/institutions. Multivariate 
analysis techniques, including contingency tables and logistic regression for binary outcomes 
and analysis of variance for continuous measures, will be used to assess differences among 
study sites to justify pooling data across sites. 
12.3.4. Multivariable Analyses 
Analysis of covariance will be performed to assess the effects of possible covariates on 
primary endpoint and some secondary endpoints as necessary. All details will be provided in 
the Statistical Analysis Plan (SAP). 
12.3.5. Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the analyses will be 
documented in an amended Statistical Analysis Plan approved prior to performing the 
analyses. Changes from the planned statistical methods after performing the analyses will be 
documented in the clinical study report along with a reason for the deviation. 
13. Data Management 
13.1. Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system.  
The clinical database will reside on a production server hosted by EDC System. All changes 
made to the clinical data will be captured in an electronic audit trail and available for review 
by the sponsor or its representative. The associated RAVE software and database have been 
designed to meet regulatory compliance for deployment as part of a validated system 
compliant with laws and regulations applicable to the conduct of clinical studies pertaining to 
the use of electronic records and signatures. Database backups are performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data 
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be issued to the site for appropriate response. Site staff will be responsible for resolving all 
queries in the database.  
13.1.1. Electronic Questionnaires 
Questionnaires in electronic form may be collected directly using an electronic data 
collection platform at the clinical site (e.g. iPad). After completion by the subject or a 
clinician, data from the electronic questionnaires are transmitted directly into the EDC 
system. 
13.1.2. Direct Data Upload 
For quality assurance purposes and validation, technical data on the SCS device will be 
collected using direct data upload to a secure BSC server. BSC Field personnel, who assist in 
programming the device settings per routine care, will upload the device files to a secure 
server stored in a restricted location at BSC. 
Device files will also be uploaded into the EDC system. 
13.2. Study Assessments 
13.2.1. 
Adverse Events 
Adverse event evaluation will be conducted to identify adverse events occurring during the 
study and classify them in regards to seriousness, relationship to the implant procedure 
and/or device, action taken and outcome. Safety events will be reported as specified in Table 
20.4-1. 
All device and procedure related non-serious adverse events, all serious adverse events, and 
unanticipated adverse events will be collected from the time of consent through the end of 
the study.   
13.2.2. 
Beck Depression Inventory (BDI-II) 
BDI-II measures the intensity, severity, and depth of depression. It includes a long form of 21 
questions, each evaluating a specific depression symptom (e.g., sadness, pessimism, 
irritability, loss of energy, concentration difficulty, indecisiveness, changes in sleep pattern, 
fatigue, etc.). 
13.2.3. 
Concomitant Medications  
All opioid pain-related medications will be collected throughout the study in order to obtain a 
full record of medication-related resource utilization. Information will include medication 
name, dates of prescription, indication or purpose, dose, frequency, and route of 
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13.2.4. 
Clinical Global Impression of Change (CGI-C) 
CGI-C is a seven-point scale that requires the clinician to assess how much the subject’s 
condition has improved or worsened relative to the subject’s enrollment in the study. The 
clinician will rate the subject’s change as: very much improved; much improved; minimally 
improved; no change; minimally worse; much worse; or very much worse. 
13.2.5. 
Demography 
Demographic information will include date of birth, gender, and race/ethnicity.   
13.2.6. 
EQ-5D 5 Level (EQ-5D-5L) 
EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in 
order to provide a simple, generic measure of health for clinical and economic appraisal.  
Applicable to a wide range of health conditions and treatments, it provides a simple 
descriptive profile and a single index value for health status that can be used in the clinical 
and economic evaluation of health care as well as in population health surveys.     
EQ-5D-5L is comprised of a descriptive system and a visual analog scale. The descriptive 
system measures quality of life along five dimensions, including mobility, self-care, usual 
activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from 
which subjects are asked to select one. The visual analog scale is used to record the subject’s 
self-rated health on a 20cm vertical line with endpoints labeled ‘the best health you can 
imagine’ and ‘the worst health you can imagine’.    
13.2.7. 
Medical History 
Medical history will include medical and procedural history relating to pain management, 
onset of chronic pain, all pain-related diagnoses and medical/psychological conditions, 
medication use etc.   
13.2.8. 
Oswestry Disability Index Version 2.1a (ODI v2.1a) 
ODI v2.1a assesses the degree of subject disability due to pain, measuring the impact of pain 
on activities of daily living. ODI v2.1a is composed of 10 questions that describe the pain 
and its impact on daily life on a 0 - 5 scale, with higher values indicating the more severe 
impact. 
13.2.9. 
Pain Intensity: NRS 
Pain Intensity: NRS is a questionnaire that assesses the intensity of the subject’s pain 
intensities, including overall, leg, and low back pain over the past 7 days. Pain intensity is 
expressed on a 0 – 10 numerical rating scale (NRS), where 0 indicates “no pain” and 10 
indicates “pain as bad as you can imagine” as self-reported by the subject.  

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13.2.10. 
Pain Intensity: VRS 
Pain Intensity: VRS is a questionnaire that verbally assesses the intensity of the subject’s 
pain intensities, including overall, leg, and low back pain over the past 7 days. This is done 
based on a clinician interview (e.g. study personnel such as physician or study coordinator) 
with the subject.  
Pain intensity is expressed on a 0 – 10 verbal rating scale (VRS), where 0 indicates “no pain” 
and 10 indicates “pain as bad as you can imagine”, verbally reported by the subject to study 
personnel.  
13.2.11. 
Procedure Information 
General information will be collected regarding the SCS procedures performed during the 
study, including implant, explant and revision procedures. 
13.2.12. 
Patient Global Impression of Change (PGI-C) 
PGI-C is a seven-point scale that requires the subject to assess how much their condition has 
improved or worsened relative to their baseline. Subjects will rate themselves as: very much 
improved; much improved; minimally improved; no change; minimally worse; much worse; 
or very much worse. 
13.2.13. 
Percent Pain Relief (PPR) 
PPR is a questionnaire assessing how much of the subject’s low back pain and leg pain has 
been relieved by the SCS treatment. Pain relief is expressed as a percentage from 0 – 100%. 
13.2.14. 
Preference Questionnaire 
The Preference Questionnaire assesses the subjects’ preference for treatment based on the 
options offered during the study. 
13.2.15. 
Programming Parameters 
Standard information regarding the programming parameters used to program the subject’s 
IPG, as well as measurements taken using the device (e.g. contact impedances) will be 
collected from the Clinician Programmer (CP).   
13.2.16. 
Resource Utilization Inventory (RUI) 
Health-related resource utilization data will be collected to support the health economic 
analyses. Resource utilization categories include: office/hospital visits, diagnostic tests, and 
non-surgical procedures.  

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13.2.17. 
Short-Form Health Survey 36 Item (SF-36v2) 
The SF-36v2 measures subjects’ functional health and well-being from their own point of 
view.  SF-36v2 is comprised of 36 questions spanning eight health domains: physical 
functioning, role-physical, bodily pain, general health, vitality, social functioning, role-
emotional, and mental health. All health domain scales contribute to the scoring of two 
component summary measures: physical health and mental health. 
13.2.18. 
Therapy Rating 
The Remote Control has a therapy rating feature. Subjects may be instructed to perform 
therapy ratings at a frequency that may be up to daily. Information regarding therapy ratings 
will be collected from the Clinical Programmer, as applicable.  
13.2.19. 
Treatment Satisfaction Questionnaire for Medication – modified 
(TSQM-9m) 
TSQM-9 is a 9-item instrument validated for the assessment of subjects’ satisfaction with a 
medication across three domains: effectiveness, convenience, and global satisfaction. TSQM-
9m is a slightly modified version developed for this study in which the term ‘medication’ is 
substituted for ‘device’ to be applicable with a medical device treatment.    
13.2.20. 
Work Productivity (WPAI-SHP v2.0) 
WPAI:SHP v2.0 assesses the amount of absenteeism, presenteeism, and daily activity 
impairment attributable to a specific health problem. The specific health problem in this 
study is chronic pain. WPAI:SHP v2.0 consists of six questions addressing the subject’s 
employment status, true work status, productivity while working, and ability to carry out 
regular daily activities. 
13.3. Data Retention 
The Principal Investigator or his/her designee or Investigational site will maintain, at the 
investigative site, all essential study documents and source documentation that support the 
data collected on the study subjects in compliance with ICH/GCP guidelines. Documents 
must be retained for at least 2 years after the last approval of a marketing application or until 
at least 2 years have elapsed since the formal discontinuation of the clinical investigation of 
the product. These documents will be retained for a longer period of time by agreement with 
BSC or in compliance with other country/regional/local regulations.  
The Principal Investigator or his/her designee will take measures to ensure that these 
essential documents are not accidentally damaged or destroyed. If for any reason the 
Principal Investigator or his/her designee withdraws responsibility for maintaining these 
essential documents, custody must be transferred to an individual who will assume 
responsibility and BSC must receive written notification of this custodial change. Sites are 
required to inform Boston Scientific in writing where paper or electronic files are maintained 
in case files are stored off site and are not readily available. 

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14. Amendments  
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Appropriate approvals (e.g., IRB) 
of the revised protocol must be obtained prior to implementation. 
15. Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor 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, and those deviations which affect 
the scientific integrity of the clinical investigation. Such notice shall be given as soon as 
possible, but no later than 5 working days after the emergency occurred, or per prevailing 
local requirements, if sooner than 5 working days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using the EDC system. Sites 
may also be required to report deviations to the IRB, per local guidelines and government 
regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including site re-training, or site termination) will be put 
into place by the sponsor. 
Adherence to medication lock requirements will be assessed from the Medication Lock Visit 
through the 3-Month Visit. If a change to a medication(s) occurs, or subjects do not take 
medications as specified at the Medication Lock Visit, a protocol deviation will be issued.  
Adherence to programming lock requirements will be confirmed at all study follow-up visits, 
from the Programming Lock Visit through the 3-Month Visit. A protocol deviation will be 
issued if programming changes are made at any time other than required for replacement or 
revision procedures or to resolve a device and/or stimulation-related AE.  
A Protocol Deviation will not be issued if a subject does not evaluate all programs or if a 
subject does not perform Remote Control therapy ratings, as applicable. 
16. Device/Equipment Accountability 
Commercially approved Spectra WaveWriter SCS Systems are used in this study per the 
Directions for Use; no investigational devices are used.  

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17. Compliance 
17.1. Statement of Compliance 
This study will be conducted in accordance with 21 CFR 50 and 56, ISO 14155: Clinical 
Investigation of Medical Devices for Human Subjects – Good Clinical Practice, the relevant 
parts of the ICH Guidelines for Good Clinical Practices, ethical principles that have their 
origins in the Declaration of Helsinki, and pertinent individual country laws and regulations. 
The study shall not begin until the required approval/favorable opinion from the IRB and/or 
regulatory authority has been obtained, if appropriate. Any additional requirements imposed 
by the IRB or regulatory authority shall be followed, if appropriate.  
17.2. Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the Clinical Investigational 
Plan/Protocol, ISO 14155, applicable Code of Federal Regulations, ethical principles that 
have their origins in the Declaration of Helsinki, any conditions of approval imposed by the 
reviewing IRB, and prevailing local and/or country laws and/or regulations, whichever 
affords the greater protection to the subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following:  
• Prior to beginning the study, sign the Clinical Study Agreement and comply with the 
Investigator responsibilities as described in such Agreement.   
• Prior to beginning the study, sign the Investigational Plan/Protocol signature page 
documenting his/her agreement to conduct the study in accordance with the protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the site team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical study. 
• Report protocol deviations to the sponsor, IRB and/or regulatory authorities, as required 
by the protocol, IRB guidelines, and/or national/regulatory regulations. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical 
investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 

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• Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event as applicable per the protocol and observed device deficiency. 
• Report to the sponsor, per the protocol requirements, all SAEs and device deficiencies 
that could have led to a SADE and potential/USADE or UADE. 
• Report to the IRB and regulatory authorities any SAEs and device deficiencies that could 
have led to a SADE and potential/USADE or UADE, if required by the national 
regulations or this protocol or by the IRB, and supply BSC with any additional requested 
information related to the safety reporting of a particular event. 
• Maintain device disposition records and ensure that the device components are used only 
by authorized/designated users and in accordance with this protocol and Directions for 
Use. 
• Allow the sponsor to perform monitoring and auditing activities, and be accessible to the 
clinical research monitor or auditor and respond to questions during monitoring visits or 
audit(s). 
• Allow and support regulatory authorities and the IRB when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 
• Inform the subject of the nature and possible cause of any adverse events experienced. 
• As applicable, provide the subject with necessary instructions on proper use, handling, 
storage, and return of the device. 
• Inform the subject of any new significant findings occurring during the clinical study, 
including the need for additional medical care that may be required. 
• Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment. 
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical study are provided with some 
means of showing their participation in the clinical study, together with identification and 
compliance information for concomitant treatment measures (contact address and 
telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical study. 

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• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical study while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical study. 
• Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical study is appropriately performed and documented, where applicable. 
17.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the Principal Investigator is responsible for providing 
appropriate training and adequate supervision of those to whom tasks are delegated. The 
investigator is accountable for regulatory violations resulting from failure to adequately 
supervise the conduct of the clinical study.  
17.3. Institutional Review Board 
Prior to gaining Approval-to-Enroll status, the investigational site will provide to the sponsor 
documentation verifying that their IRB is registered or that registration has been submitted to 
the appropriate agency, as applicable according to national/regulatory requirements.   
A copy of the written IRB approval of the protocol (or permission to conduct the study) and 
Informed Consent Form, must be received by the sponsor before recruitment of subjects into 
the study. Prior approval must also be obtained for other materials related to subject 
recruitment or which will be provided to the subject. 
Annual IRB approval and renewals will be obtained throughout the duration of the study as 
required by local/country or IRB requirements. Copies of the Investigator’s reports and the 
IRB continuance of approval must be provided to the sponsor.  
17.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC. Only authorized BSC personnel or a BSC 
representative including, but not limited to Contract Research Organization (CRO) will have 
access to these confidential records. Authorized regulatory personnel have the right to inspect 
and copy all records pertinent to this study. Study data collected during this study may be 
used by BSC for the purposes of this study, publication, and to support future research and/or 
other business purposes. All data used in the analysis and reporting of this study will be 
without identifiable reference to specific subject name. 
Boston Scientific will keep subjects’ identifiable health information confidential in 
accordance with all applicable laws and regulations. Boston Scientific may use subjects’ 
health information to conduct this research, as well as for additional purposes, such as 
overseeing and improving the performance of its device, new medical research and proposals 
for developing new medical products or procedures, and other business purposes. 

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Information received during the study will not be used to market to subjects; subject names 
will not be placed on any mailing lists or sold to anyone for marketing purposes.  
17.4.1. Role of Boston Scientific Representatives 
Boston Scientific personnel can provide technical support to the investigator and other health 
care personnel (collectively HCP) as needed during implant, testing required by the protocol, 
and follow-ups. Support may include HCP training, addressing HCP questions, or providing 
clarifications to HCPs concerning the operation of BSC equipment/devices (including 
programmers, analyzers, and other support equipment). 
At the request of the investigator and while under investigator supervision, BSC personnel 
may operate equipment during implant or follow-up, assist with the conduct of testing 
specified in the protocol, and interact with the subject to accomplish requested activities.  
Typical tasks may include the following: 
• Interrogating the device or programming device parameters to investigator-requested 
settings as well as operating investigational equipment. 
• Performing device testing using a programmer to obtain thresholds and impedance 
measurements. 
• Clarifying device behavior, operation or diagnostic output as requested by the 
investigator or other health care personnel. 
• Assisting with the collection of study data from programmers and other equipment. 
• Provide programming reports directly from the clinician programmer. 
• Provide technical expertise/support to subjects during office visits and/or during 
teleconference calls/electronic communications with the principal investigator or their 
delegated site staff and the subject.  
In addition, BSC personnel may perform certain activities to ensure study quality. These 
activities may include the following. 
• Observing testing or medical procedures to provide information relevant to protocol 
compliance. 
• Reviewing collected data and study documentation for completeness and accuracy. 
Boston Scientific personnel will not do the following:  
• Practice medicine 
• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject without the approval and 
presence of the investigator 
• Independently collect critical study data (defined as primary or secondary endpoint data) 
• Enter data in electronic data capture systems or on paper case report forms 

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18. Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the clinical research monitor verifies that 
study records are adequately maintained, that data are reported in a satisfactory manner with 
respect to timeliness, adequacy, and accuracy, and that the Principal Investigator continues to 
have sufficient staff and facilities to conduct the study safely and effectively. The Principal 
Investigator/institution guarantees direct access to original source documents by BSC 
personnel, their designees, the IRB, and appropriate regulatory authorities. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by the IRB and/or appropriate regulatory authorities. It is important that the 
Principal Investigator and relevant study personnel are available during on-site monitoring 
visits or audits and that sufficient time is devoted to the process. 
19. Potential Risks and Benefits 
19.1. Anticipated Adverse Events  
The following anticipated adverse events (AE) have been identified for this study. 
Very Common: 
• Minor bruising 
• Post-operative pain and swelling 
Common: 
• Nausea associated with anesthesia 
Less Common: 
• Infection such as cellulitis or subcutaneous abscess 
• Pain  
Uncommon: 
• Swelling  
• Worsened back pain 
Rare: 
• Abnormal healing or failure to heal 
• Allergic, immune, or inflammatory response or reaction to medication or surgical 
materials 

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• Death 
• Deep vein thrombosis/thrombophlebitis 
• Depression due to unmet expectations of treatment 
• Dural tear with or without CSF leak  
• Headache 
• Hematoma of a serious type, e.g. an epidural hematoma resulting in paralysis 
• Hemorrhage requiring transfusion 
• Infection that is severe or life-threatening, such as epidural abscess, meningitis or sepsis 
• Nerve injury, which can result in symptoms such as tingling, numbness, pain, loss of 
bladder or bowel control, weakness, or paralysis 
• Pneumothorax, Pneumocephalus, or injury to other tissues during surgery 
• Pulmonary embolism 
• Radiation exposure (harm from this is rare) 
• Respiratory arrest, e.g. apnea during surgical procedure 
• Risks associated with anesthesia and any type of surgery, e.g. exposure to biohazardous 
materials 
19.2. Anticipated Adverse Device Effects  
The risks summarized below are anticipated during use of SCS as described in this protocol. 
The risks listed include those associated with the procedure to implant the SCS device 
system, the presence of the device (whether activated or not) within the body, and the use of 
SCS stimulation1. Potential risks not already identified may exist. 
The following anticipated adverse device effects (ADE) have been identified for the SCS 
device.  
Very Common: 
• Minor bruising 
Common: 
• Additional surgical procedure such as explant, revision, or reimplantation  of the 
leads, extensions, or IPG, or revision of the IPG pocket 
• Pain, including pain at IPG  
                                                 
1 Note that some of these symptoms may be resolved or reduced by current steering, changing stimulation 
parameters, or by repositioning of the lead. 

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• Stimulation in non-target areas, which can include undesired sensations of pain, 
pressure, or numbness 
• Undesired sensations at stimulation target areas, which can include feelings of pain, 
pressure, numbness, or dislike of paresthesia  
• Overstimulation of tissue, which can include feeling sensations such as jolts or 
shocks, and potential injuries arising from this causing distraction or loss of muscle 
control (e.g. fall) 
Less Common: 
• Infection, such as cellulitis or subcutaneous abscess  
Uncommon: 
• Discomfort, which can include minor tenderness, uncomfortable awareness of the 
device, or anxiety 
• Skin erosion, including pressure sores, over the device 
• Swelling, including seroma, at the IPG site or other locations 
• Weight gain or loss 
Rare: 
• Abnormal healing or failure to heal 
• Allergic, immune, or inflammatory response or reaction to the presence of the device 
or its materials 
• Burns due to charger misuse 
• Death 
• Dural tear with or without Cerebrospinal Fluid (CSF) leak 
• Error during implantation of device, e.g. faulty connection of extension to the IPG, 
which can lead to additional surgery 
• Headache 
• Hematoma of a serious type, e.g. an epidural hematoma resulting in paralysis 
• Hemorrhage requiring transfusion 
• Inability to change stimulation, e.g. the remote control stops working 
• Infection that is severe or life-threatening, such as epidural abscess, meningitis or 
sepsis 
• Muscle spasms 
• Musculoskeletal stiffness 

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• Nausea 
• Nerve injury arising from the electrodes, which can result in symptoms such as 
unintended tingling, numbness, pain, loss of bladder or bowel control, weakness, or 
paralysis 
• Pneumothorax, pneumocephalus, or injury to other tissues during surgery  
• Seizure 
• Stimulation-related symptoms in other body systems, e.g. changes to urinary function, 
priapism 
• Tissue damage at implant site from exposure to MRI 
19.3. Risks Associated with the Study Device(s)  
There are no known incremental risks associated with the study device above those of 
market-available products.  
19.4. Risks associated with Participation in the Clinical Study 
The subject might find it difficult, uncomfortable, or tiresome to complete study visits, 
evaluate the device, and/or questionnaires. 
19.5. Possible Interactions with Concomitant Medical Treatments 
No possible interactions have been identified for use of the SCS system concomitant with 
any specific medications. However, there may be some risk that is unknown. 
The following medical treatments should not be used while the SCS lead remains implanted. 
Magnetic Resonance Imaging (MRI). The subject should not be exposed to Magnetic 
Resonance Imaging (MRI). Exposure to this diagnostic technology may result in 
dislodgement of the Stimulator or lead(s), heating of the Stimulator, damage to the 
Stimulator electronics and/or voltage induction through the leads or Stimulator which can 
cause an uncomfortable or “jolting” sensation. 
Diathermy. SCS subjects should not have any form of diathermy either as treatment for a 
medical condition or as part of a surgical procedure. The high energy and heat generated by 
diathermy can be transferred through the stimulator system, causing tissue damage at the lead 
site and, possibly, severe injury or death. The Stimulator, whether it is turned on or off, may 
be damaged. 
Implanted Stimulation Devices. Spinal cord stimulators may interfere with the operation of 
implanted sensing stimulators such as pacemakers or cardioverter defibrillators. The effects 
of implanted stimulation devices on neurostimulators are unknown. 
Medical Devices/Therapies. The following medical therapies or procedures may turn 
stimulation off or may cause permanent damage to the Stimulator, particularly if used in 
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• Lithotripsy 
• Electrocautery (See “Instructions for the Physician” in the Information for the 
Prescriber Manual) 
• External defibrillation 
• Radiation therapy 
• Ultrasonic scanning 
• High-output ultrasound 
19.6. Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject 
selection criteria, close monitoring of the subject's physiologic status during research 
procedures and/or follow-ups and by promptly supplying BSC with all pertinent information 
required by this protocol. 
19.7. Anticipated Benefits 
The reported benefit of the Spectra WaveWriter SCS System may include: 
• Reduction in the intensity of chronic low back pain 
• Reduction in the intensity of chronic leg pain 
• Reduction in overall chronic low back and leg pain 
• Improvement in physical functioning (disability) 
• Improvement in sleep 
• Improvement in quality of life 
• Improvement in depression 
• Reduction in pain-related medication use  
• Reduction in the occurrence of side-effects of pain-related medications accompanied 
by reduction in opioid use (e.g. sleep disturbances, constipation, reduction in mental 
acuity) 
19.8. Risk to Benefit Rationale 
The risk evaluation for the Spectra WaveWriter SCS System determined that all hazards 
attributed to the Spectra WaveWriter SCS System and overall remaining residual risks after 
implementations of the required mitigations have been evaluated. Based on the risk 
evaluation results, the benefit provided by the Spectra WaveWriter SCS System to treat 
chronic intractable pain of the trunk and limbs outweighs the remaining residual risk. As the 

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overall residual risk meets BSN’s criteria, the Spectra WaveWriter SCS System is acceptable 
for use in a clinical setting. 
20. Safety Reporting 
20.1. Reportable Events by investigational site to Boston Scientific 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories: 
• All Serious Adverse Events 
• All Investigational Device Deficiencies  
• Unanticipated Adverse Device Effects  
• Non-serious device and/or procedure related adverse events 
• New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Any AE event required by the protocol, experienced by the study subject after informed 
consent and once considered enrolled in the study (as defined in study subject classification 
section), whether during or subsequent to the procedure, must be recorded in the eCRF. 
Underlying diseases are not reported as AEs unless there is an increase in severity of 
frequency during the course of the investigation. Death should not be recorded as an AE, but 
should only be reflected as an outcome of ONE (1) specific SAE (see Table 20.2-1 for AE 
definitions). 
Refer to Section 19 for the known risks associated with the study device(s). 
20.2. Definitions and Classification 
Adverse event definitions are provided in Table 20.2-1. Administrative edits were made on 
the definition of serious adverse event from ISO 14155 and MEDDEV 2.7/3 for clarification 
purposes. 
Table 20.2-1: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Any untoward medical occurrence, unintended disease or injury, or any untoward 
clinical signs (including an abnormal laboratory finding) in subjects, users or other 
persons, whether or not related to the investigational medical device.  
NOTE 1: This includes events related to the investigational medical device or 
comparator. 

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Table 20.2-1: Safety Definitions 
Term 
Definition 
Ref: MEDDEV 
2.7/3  
 
 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to 
the investigational medical device.  
Adverse Device 
Effect (ADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 
2.7/3  
Adverse event related to the use of an investigational medical device 
NOTE 1: This includes any adverse event resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, the implantation, the 
installation, the operation, or any malfunction of the investigational medical 
device. 
NOTE 2: This definition includes any event resulting from use error or intentional 
abnormal use of the investigational medical device. 
Serious Adverse 
Event (SAE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 
2.7/3  
Note: This definition meets the reporting objectives and requirements of ISO 14155 
and MEDDEV 2.7/3. 
Adverse event that: 
a) Led to death, 
b) Led to  serious deterioration in the health of the subject as defined by either: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient hospitalization or prolongation of existing 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) Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a procedure 
required by the clinical investigational plan, without a serious deterioration in health, 
is not considered a serious adverse event.  
Serious Adverse 
Device Effect 
(SADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 
2.7/3  
Adverse device effect that has resulted in any of the consequences characteristic of a 
serious adverse event. 
 
Unanticipated 
Adverse Device 
Effect (UADE) 
 
Ref: 21 CFR Part 
812 
 
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 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.   
Device Deficiency 
 
Ref: ISO 14155 
 
An inadequacy of an investigational medical device related to its identity, quality, 
durability, reliability, safety or performance. This may include malfunctions, use 
error, or inadequacy in the information supplied by the manufacturer. 
 

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Table 20.2-1: Safety Definitions 
Term 
Definition 
Ref: MEDDEV 
2.7/3  
Abbreviations: IRB=Institutional Review Board 
 
Underlying diseases are not reported as AEs unless there is an increase in severity or 
frequency during the course of the investigation. Death should not be recorded as an AE, but 
should only be reflected as an outcome of a specific SAE.  
Any AE experienced by the study subject after informed consent, whether during or 
subsequent to the procedure, must be recorded in the eCRF. 
Refer to Section 19 for the known risks associated with the study device(s). 
NOTES: 
1. For the purposes of this study, hospitalization is defined as any in-patient admission.  
2. Hospitalizations occurring for the purpose of performing a planned procedure as per 
routine care such as implant procedures, or follow-up visits, are not to be reported as 
a SAE. However, complications or adverse events that occur during the planned 
procedure should be reported as (S)AEs if they meet the protocol specified 
definitions.  
3. Elective/planned hospitalization(s) need not be reported as an SAE. However, 
complications or adverse events that occur during an elective/planned hospitalization, 
should be reported as (S)AEs if they meet the protocol specified definitions.  
4. In the event of subject death during the conduct of the study, efforts should be made 
to perform an autopsy.  
5. Sensations or side effects that occur during the programming session should not be 
reported as AEs. However, undesired sensations or side effects caused by the final 
programming parameters (including active contact, pulse width, frequency, and 
amplitude) that persist or occur after the completion of the programming should be 
reported as AEs. 
6. Lack of efficacy/decreased therapeutic response should not be reported as AEs. 
Clinical sequelae, other than pain, that occur as a result of lack of efficacy/decreased 
therapeutic response should be reported as AEs 
7. Clinically significant worsening of the pattern of intensity or distribution of Baseline 
pain symptoms should be reported as an AE.  
8. Device deficiencies, including, but not limited to device/lead migrations, which are 
not associated with an adverse clinical outcome should only be reported as device 
deficiencies.  However, if a device deficiency precipitates an AE, the AE should be 
reported in the Adverse Event eCRF and the device deficiency should be documented 
in the Device Deficiency eCRF.  

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20.3. Relationship to Study Device(s) 
The Investigator must assess the relationship of the AE to the study device or procedure. See 
criteria in Table 20.3-1.  
Table 20.3-1: Criteria for Assessing Relationship of Study Device or Procedure to 
Adverse Event 
Classification 
Description 
Not Related 
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 serious 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 serious event can be attributed to another cause (e.g., an underlying 
or concurrent illness / clinical condition, an effect of another device, drug, or 
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; 
- In order to establish the non-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.   
Unlikely Related 
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. 
Possibly Related 
The relationship with the use of the investigational 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. 
Probably Related 
The relationship with the use of the investigational device seems relevant and/or the 
event cannot reasonably explained by another cause, but additional information may 
be obtained. 
Causal Relationship 
The serious event is associated with the investigational device or with 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 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; 

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- the serious 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 serious 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; 
- In order 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. 
Abbreviations: IRB=Institutional Review Board 
 
The Investigator must assess the potential relationship of all adverse events to the study 
device and study procedure. All study device related adverse events will be assessed 
according to their relationship to one of the following sub-categories: 
• Device Hardware-Related AEs: AEs that can reasonably be attributed to the mere 
physical presence of the device or to deficiency of the device (i.e., an allergic 
response to device materials).  
• Stimulation-Related AEs: AEs that can reasonably be attributed to the effects of 
stimulation. A relationship to stimulation may be determined by demonstrating a 
predictable response to the alternating between stimulation-on and stimulation-off 
settings.  However, a relationship to stimulation may also be reported without 
demonstrating a predictable response to the alternating between the stimulation-on 
and stimulation-off settings if in the opinion of the Investigator the AE is potentially 
related to stimulation.  
20.4. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 20.4-1. 
Table 20.4-1: Investigator Reporting Requirements
Event Classification 
Communication Method  
Communication Timeline post-market 
studies**  
(MEDDEV 2.12/2: GUIDELINES ON A 
MEDICAL DEVICE VIGILANCE 
SYSTEM) 
Unanticipated Adverse Device 
Effect    
 
Complete AE eCRF page 
with all available new and 
updated information.  
• Within 1 business day of first becoming 
aware of the event. 
• Terminating at the end of the study 
Serious Adverse Event  
Complete AE eCRF page 
with all available new and 
updated information.  
• Within 10 business days after becoming 
aware of the event or as per local/regional 
regulations. Reporting required through the 
end of the study 

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Table 20.4-1: Investigator Reporting Requirements
Event Classification 
Communication Method  
Communication Timeline post-market 
studies**  
(MEDDEV 2.12/2: GUIDELINES ON A 
MEDICAL DEVICE VIGILANCE 
SYSTEM) 
Provide all relevant source 
documentation (unidentified) 
for reported event upon 
request of the sponsor. 
• When documentation is available 
Serious Adverse Device Effects 
Complete AE eCRF page 
with all available new and 
updated information. 
• Within 2 business days of first becoming 
aware of the event or as per local/regional 
regulations. 
• Reporting required through the end of the 
study 
Provide all relevant source 
documentation (unidentified) 
for reported event 
• When documentation is available 
Device Deficiencies (including 
but not limited to failures, 
malfunctions, and product 
nonconformities) 
Note:  Any Investigational 
Device Deficiency that might 
have led to a serious adverse 
event if a) suitable action had 
not been taken or b) 
intervention had not been made 
or c) if circumstances had been 
less fortunate is considered a 
reportable event.  
Complete Device Deficiency 
eCRF with all available new 
and updated information.  
• Within 2 business days of first becoming 
aware of the event.  
• Reporting required through the end of the 
study 
Adverse Device Effects 
Complete AE eCRF page, 
which contains such 
information as date of AE, 
treatment of AE resolution, 
assessment of seriousness 
and relationship to the 
device.  
• In a timely manner  (e.g. recommend 
within 30 business days) after becoming 
aware of the information 
• Reporting of Adverse events which are 
device/procedure related will be required 
through the end of the study.  
Abbreviations: AE=adverse event; CRF=case report form; IDE=Investigational Device Exemption; UADE=unanticipated adverse device effect 
20.5. Boston Scientific Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, 
product nonconformities, and inadequacy in the information supplied by the manufacturer) 
will be documented and reported to BSC. If possible, the device(s) should be returned to 
BSC for analysis. Instructions for returning the investigational device(s) will be provided to 
study sites. If it is not possible to return the device, the investigator should document why the 

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device was not returned and the final disposition of the device. Device failures and 
malfunctions should also be documented in the subject’s medical record. 
 Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not adverse events. However, an adverse event that results from a 
device failure or malfunction should be recorded as an adverse event on the appropriate 
eCRF. 
20.6. Reporting to Regulatory Authorities / IRBs / Investigators 
BSC is responsible for reporting adverse event information to all participating Principal 
Investigators and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the IRB, and regulatory authorities of 
UADE and SAE as required by local/regional regulations. 
21. Informed Consent 
Subject participation in this clinical study is voluntary. Informed Consent is required from 
each subject. The Investigator is responsible for ensuring that Informed Consent is obtained 
prior to the use of any devices, study-required procedures and/or testing, or data collection.  
The obtaining and documenting Informed Consent must be in accordance with the principles 
of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and local IRB 
and/or regulatory authority body, as applicable. The ICF must be accepted by Boston 
Scientific (BSC), and approved by the site’s IRB, or central IRB, if applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative site’s IRB. Any modification requires acceptance from BSC prior to use of the 
form. The ICF must be in a language understandable to the subject. Privacy language shall be 
included in the body of the form or as a separate form, as applicable.   
The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the process,  
• include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 
• use native language that is non-technical and understandable to the subject, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 

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• ensure important new information is provided to new and existing subjects throughout the 
clinical study.  
The ICF shall always be signed and personally dated by the subject under the applicable 
laws, rules, regulations and guidelines and by the investigator and/or an authorized designee 
responsible for conducting the informed consent process. The original signed ICF will be 
retained by the site and a copy of the signed and dated document and any other written 
information must be given to the subject.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory body 
according to their requirements (e.g., FDA requirement is within 5 working days of learning 
of such an event). Any violations of the informed consent process must be reported as 
deviations to the sponsor and local regulatory authorities (e.g. IRB), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB. The new version of the ICF must be approved by the 
IRB. Acceptance by Boston Scientific is required if changes to the revised ICF are requested 
by the site’s IRB. The IRB will determine the subject population to be re-consented. 
Study personnel should explain that even if a subject agrees to participate in the study and 
signs an Informed Consent form, screening procedures may demonstrate that the subject is 
not a suitable candidate for the study. 
22. Suspension or Termination 
23.1 Premature Termination of the Study 
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or administrative reasons and reasons 
related to protection of subjects. Investigators, associated IRBs, and regulatory authorities, as 
applicable, will be notified in writing in the event of study termination. 
23.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
• The occurrence of unanticipated adverse device effects that present a significant or 
unreasonable risk to subjects enrolled in the study. 
• An enrollment rate far below expectation that prejudices the conclusion of the study.  

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• A decision on the part of Boston Scientific to suspend or discontinue development of the 
device. 
23.2 Termination of Study Participation by the Investigator or Withdrawal of IRB 
Approval 
Any investigator or IRB in the VERITAS Study may discontinue participation in the study or 
withdrawal approval of the study, respectively, with suitable written notice to Boston 
Scientific. Investigators, associated IRBs, and regulatory authorities, as applicable, will be 
notified in writing in the event of these occurrences. 
23.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating sites by Boston Scientific. The 
IRB and regulatory authorities, as applicable, will be notified. Detailed information on how 
enrolled subjects will be managed thereafter will be provided.  
In the event an IRB terminates participation in the study, participating investigators, 
associated IRBs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be provided 
by Boston Scientific. 
In the event a Principal Investigator terminates participation in the study, study responsibility 
will be transferred to another investigator, if possible. In the event there are no opportunities 
to transfer Principal Investigator responsibility; detailed information on how enrolled 
subjects will be managed thereafter will be provided by Boston Scientific. 
The Principal Investigator or his/her designee must return all study-related documents and 
products to Boston Scientific, unless this action would jeopardize the rights, safety, or 
welfare of the subjects. 
23.4 Criteria for Suspending/Terminating a Study Site 
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a study 
site at any time after the study initiation visit if no subjects have been enrolled or if the site 
has multiple or severe protocol violations/noncompliance without justification and/or fails to 
follow remedial actions. 
In the event of termination of site participation, all study-related products, as applicable, will 
be returned to BSC unless this action would jeopardize the rights, safety or well-being of the 
subjects. The IRB and regulatory authorities, as applicable, will be notified. All subjects 
enrolled in the study at the site will continue to be followed according to the protocol and the 
end of study action plan. The Principal Investigator at the site must make provision for these 
follow-up visits unless BSC notifies the investigational site otherwise. 
BSC may also consider transferring active subjects from the site that is being closed to 
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 Possible reasons for suspending/terminating a study center include: 
• 
Persistent non-compliance with protocol; 
• 
Repeated failure to complete CRFs in a timely manner; 
• 
Failure to obtain written Informed Consent; 
• 
Failure to report UADE within 1 business day after “becoming aware date” and 
SAE within 2 business days after becoming aware date to BSC; 
• 
Loss of study product inventory; 
• 
Failure to enroll subjects. 
23. Publication Policy 
BSC requires disclosure of its involvement as a sponsor or financial supporter in any 
publication or presentation relating to a BSC study or its results. BSC will submit study 
results for publication (regardless of study outcome) following the conclusion or termination 
of the study. Boston Scientific Corporation adheres to the Contributorship Criteria set forth in 
the Uniform Requirements of the International Committee of Medical Journal Editors 
(ICMJE; http://www.icmje.org). In order to ensure the public disclosure of study results in a 
timely manner, while maintaining an unbiased presentation of study outcomes, BSC 
personnel may assist authors and investigators in publication preparation provided the 
following guidelines are followed. 
• All authorship and contributorship requirements as described above must be followed. 
• BSC involvement in the publication preparation and the BSC Publication Policy should 
be discussed with the Coordinating Principal Investigator(s) at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  
24. Bibliography 
Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 
20-year literature review. J Neurosurg. 2004 Mar;100(3 Suppl Spine):254-67.    
Carter ML. Spinal cord stimulation in chronic pain: a review of the evidence. Anaesth 
Intensive Care. 2004 Feb;32(1):11-21. 
De Ridder D, Vanneste S, Plazier M, van der Loo E, Menovsky T. Burst spinal cord 
stimulation: toward paresthesia-free pain suppression. Neurosurgery. 2010 May;66(5): 
986-90. 
Kapural et al., Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to 
Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic 

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Back and Leg Pain The SENZA-RCT Randomized Controlled Trial., Anesthesiology, 
V 123 • No 4 
Kumar K, Hunter G, and Demeria D. Spinal cord stimulation in treatment of chronic benign 
pain: challenges in treatment planning and present status, a 22-year experience. 
Neurosurgery. 2006 Mar;58(3):481-46; discussion 481-96. 
Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, 
Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. The effects 
of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of 
the prospective randomized controlled multicenter trial of the effectiveness of spinal 
cord stimulation. Neurosurgery. 2008 Oct;63(4):762-70; discussion 770. 
Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, 
Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. Spinal cord 
stimulation versus conventional medical management for neuropathic pain: a 
multicentre randomised controlled trial in patients with failed back surgery syndrome. 
Pain. 2007 Nov;132(1-2):179-88. 
K. Lan and D. DeMets, "Discrete sequential boundaries for clinical trials," Biometrika, vol. 
70, no. 3, pp. 659-663, 1983.  
McPherson ML. Demystifying opioid conversion calculations: a guide for effective dosing. 
Bethesda: American Society of Health-System Pharmacists; 2009. 
North RB. Spinal cord stimulation for intractable pain: long-term follow-up. J Spinal Disord. 
1990 Dec;3(4):356-61. 
North RB, Ewend MG, Lawton MT, and Piantadosi S. “Spinal cord stimulation for chronic, 
intractable pain: superiority of “multi-channel” devices”, Pain. 1991 Feb;44(2);119-30 
North, R.B., et al., Spinal cord stimulation versus repeated lumbosacral spine surgery for 
chronic pain: a randomized, controlled trial. Neurosurgery, 2005. 56(1): p. 98-106; 
discussion 106-7. 
P. O'Brien and T. Fleming, "A multiple testing procedure for clinical trials.," Biometrics, vol. 
35, pp. 459-466, 1979.  
S. Pocock, "Group sequential methods in the design and analysis of clinical trials," 
Biometrika, vol. 64, no. 2, pp. 191-199, 1977. 
Sears NC, Machado AG, Nagel SJ, Deogaonkar M, Stanton-Hicks M, Rezai AR, & 
Henderson J M. Long-term outcomes of spinal cord stimulation with paddle leads in 
the treatment of complex regional pain syndrome and failed back surgery syndrome. 
Neuromodulation. 2011 Jul-Aug;14(4):312-18; discussion 318. 
Taylor RS, Taylor RJ, Van Buyten JP, Buchser E, North R, Bayliss S. The cost effectiveness 
of spinal cord stimulation in the treatment of pain: a systematic review of the 
literature. J Pain Symptom Manage. 2004 Apr;27(4):370-8. 
Van Buyten JP, Al-Kaisy A, Smet I, Palmisani S, Smith T. High-frequency spinal cord 
stimulation for the treatment of chronic back pain patients: results of a prospective 

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multicenter European clinical study. Neuromodulation. 2013 Jan-Feb;16(1):59:65; 
discussion 65-6. 
25. Abbreviations and Definitions  
25.1. Abbreviations 
Abbreviations are shown in Table 27.1-1.  Detailed definitions or descriptions are provided 
in applicable sections of the protocol. 
Table 27.1-1: Abbreviations 
Abbreviation/Acronym 
Term 
ADE 
Adverse device effect 
AE 
Adverse event 
BSC 
Boston Scientific Corporation 
BSN 
Boston Scientific Neuromodulation 
CGI-C  
Clinical Global Impression of Change 
CFR 
Code of Federal Regulations 
CRPS 
Complex Regional Pain Syndrome  
CP 
Clinician programmer 
CRF 
Case report form 
CRO 
Contract research organization 
DFU 
Directions for use 
eCRF 
Electronic case report form 
ESAP 
End of study action plan 
FBSS 
Failed back surgery syndrome 
FDA 
Food and Drug Administration 
GCP 
Good clinical practice 
HCP 
Health care personnel 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
IPG 
Implantable pulse generator 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
Mg 
Milligram 
MRI 
Magnetic Resonance Imaging 
NRS 
Numerical rating scale 
ODI 
Oswetry Disability Index 
PGI-C 
Patient Global Impression of Change 
PPR 
Percent pain relief 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SCS 
Spinal cord stimulation 
SF-36v2 
Short Form 36 Health Survey ver 2 
TSQM-9m 
Treatment Satisfaction Questionnaire for Medication - modified  

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Table 27.1-1: Abbreviations 
Abbreviation/Acronym 
Term 
UADE 
Unanticipated adverse device effect 
VRS 
Verbal rating scale