Novapak Prospective Observational Clinical Trial
Conditions: Nasal Airway Obstruction
Sponsor: Medtronic Surgical Technologies

Novapak Prospective Observational Clinical Trial  
Clinical Investigation Plan Version A 
24-Oct-2022 
NCT05747014 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
© 2024 Medtronic. No use of any Medtronic trademark may be made except to identify the product or 
services of the company or as otherwise authorized in writing by Medtronic. All rights reserved. 

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  Novapak Prospective Observational Clinical Trial 
Clinical Investigation Plan Identifier Novapak 
Study Product Name Novapak Nasal Sinus Packing and Stent 
Sponsor/Local Sponsor Medtronic ENT 
6734 Southpoint Drive North 
Jacksonville, FL 32216 
 
Canada (Local Sponsor): 
Medtronic Canada ULC 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
1-905-460-3800 
Document Version A 
Version Date October 24, 2022 
Document Reference Number MDT22031 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 
 
 
 

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Table of Contents 
Table of Contents ...................................................................................................................... 2 
1. 
Glossary .............................................................................................................................. 6 
2. 
Synopsis ............................................................................................................................. 9 
3. 
Introduction ..................................................................................................................... 12 
3.1 Background ........................................................................................................................ 12 
3.2 Purpose .............................................................................................................................. 13 
4. 
Objectives and/or Endpoints ........................................................................................... 14 
4.1 Objectives .......................................................................................................................... 14 
4.1.1 
Primary Objective(s) ............................................................................................................ 14 
4.1.2 
Secondary Objective(s) ....................................................................................................... 15 
5. 
Study Design .................................................................................................................... 16 
5.1 Duration ............................................................................................................................. 16 
5.2 Rationale ............................................................................................................................ 16 
5.3 Study Oversight .................................................................................................................. 16 
6. 
Product Description.......................................................................................................... 16 
6.1 General .............................................................................................................................. 16 
6.2 Dosage Form and Route of Administration ............................................................................. 18 
6.3 Manufacturer ...................................................................................................................... 19 
6.4 Packaging ........................................................................................................................... 19 
6.5 Intended Population ............................................................................................................ 20 
6.6 Equipment .......................................................................................................................... 20 
6.7 Product Use ........................................................................................................................ 21 
6.8 Product Training Materials .................................................................................................... 22 
6.9 Product Storage .................................................................................................................. 22 
6.10 Product Return .................................................................................................................... 22 
6.11 Product Accountability ......................................................................................................... 22 
7. 
Study Site Requirements ................................................................................................. 22 
7.1 Investigator/Investigation Site Selection ................................................................................ 22 
7.2 Study Site Activation............................................................................................................ 23 
7.3 Role of the Sponsor Representatives ..................................................................................... 24 
8. 
Selection of Subjects ........................................................................................................ 24 

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8.1 Study Population ................................................................................................................. 24 
8.2 Subject Enrollment .............................................................................................................. 24 
8.3 Inclusion Criteria ................................................................................................................. 25 
8.4 Exclusion Criteria................................................................................................................. 25 
9. 
Study Procedures ............................................................................................................. 25 
9.1 Schedule of Events .............................................................................................................. 26 
9.2 Data Collection .................................................................................................................... 27 
9.3 Scheduled Follow-up Visit Windows ...................................................................................... 27 
9.4 Subject Screening ............................................................................................................... 28 
9.5 Prior and Concomitant Medications/Therapies ........................................................................ 28 
9.6 Subject Consent .................................................................................................................. 28 
9.7 Enrollment .......................................................................................................................... 30 
9.8 Surgical Procedure .............................................................................................................. 31 
9.9 Scheduled Follow-up Visits ................................................................................................... 31 
9.10 Unscheduled Follow-up Visits ............................................................................................... 32 
9.11 SNOT-22 Questionnaires ...................................................................................................... 32 
9.12 Irrigation Compliance .......................................................................................................... 32 
9.13 Assessment of Efficacy ........................................................................................................ 32 
9.14 Assessment of Safety .......................................................................................................... 33 
9.15 Recording Data ................................................................................................................... 33 
9.16 Deviation Handling .............................................................................................................. 34 
9.17 Subject Exit, Withdrawal or Discontinuation ........................................................................... 35 
9.17.1 
Study Exit ............................................................................................................................. 35 
9.17.2 
Study Completed ................................................................................................................. 36 
9.17.3 
Lost to Follow-up ................................................................................................................ 36 
9.17.4 
Subject Chooses to Exit (i.e. Revokes Consent) .................................................................. 36 
9.17.5 
Investigator Withdraws Subject .......................................................................................... 36 
10. 
Risks and Benefits ........................................................................................................ 37 
10.1 Potential Risks .................................................................................................................... 37 
10.2 Risk Minimization ................................................................................................................ 39 
10.3 Potential Benefits ................................................................................................................ 39 
10.4 Risk-Benefit Rationale .......................................................................................................... 40 

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10.5 Risk Determination .............................................................................................................. 40 
11. 
Adverse Events and Device Deficiencies ...................................................................... 40 
11.1 Adverse Events ................................................................................................................... 40 
11.2 Device Deficiency ................................................................................................................ 41 
11.3 Processing Updates and Resolution ....................................................................................... 41 
11.4 Definitions/Classifications ..................................................................................................... 41 
11.5 Reporting of Adverse Events ................................................................................................ 45 
11.5.1 
Adverse Event and Device Deficiency Classification ........................................................... 45 
11.5.2 
Adverse Event and Device Deficiency Reporting Requirements ........................................ 46 
11.6 Subject Death ..................................................................................................................... 48 
11.6.1 
Death Classification and Reporting ..................................................................................... 49 
11.7 Product Complaint Reporting ................................................................................................ 49 
12. 
Data Review Committees ............................................................................................. 49 
12.1 Clinical Events Committee Review ......................................................................................... 49 
12.2 Data Monitoring Committee .................................................................................................. 49 
13. 
Statistical Design and Methods .................................................................................... 49 
13.1 General Aspects of Analysis .................................................................................................. 49 
13.2 Interim Analysis .................................................................................................................. 50 
13.3 Primary Objective(s) ............................................................................................................ 50 
13.4 Secondary Objective(s) ........................................................................................................ 50 
13.5 Sample Size Determination .................................................................................................. 50 
13.6 Minimization of Bias ............................................................................................................. 50 
14. 
Ethics ............................................................................................................................ 51 
14.1 Statement(s) of Compliance ................................................................................................. 51 
15. 
Study Administration .................................................................................................... 52 
15.1 Monitoring .......................................................................................................................... 52 
15.2 Data Management ............................................................................................................... 52 
15.3 Direct Access to Source Data/Documents .............................................................................. 53 
15.4 Confidentiality ..................................................................................................................... 53 
15.5 Clinical Trial Agreement ....................................................................................................... 54 
15.6 Liability/Warranty/Insurance Information .............................................................................. 54 
15.6.1 
Warranty ............................................................................................................................. 54 

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15.6.2 
Insurance (Canada) ............................................................................................................. 54 
15.6.3 
Insurance (US) ..................................................................................................................... 54 
15.6.4 
Subject Compensation ........................................................................................................ 54 
15.7 CIP Amendments ................................................................................................................ 54 
15.8 Record Retention ................................................................................................................ 54 
15.8.1 
Investigator Records ........................................................................................................... 55 
15.8.2 
Sponsor Records ................................................................................................................. 56 
15.9 Reporting Requirements ...................................................................................................... 56 
15.9.1 
Investigator Reports ............................................................................................................ 56 
15.9.2 
Sponsor Reports .................................................................................................................. 59 
15.10 
Publication and Use of Information ................................................................................ 60 
15.10.1 
Publication Committee ................................................................................................... 60 
15.10.2 
Management of Primary, Secondary, and Ancillary Publications ................................... 61 
15.10.3 
Criteria for Determining Authorship ............................................................................... 61 
15.10.4 
Transparency ................................................................................................................... 62 
15.11 
Suspension or Early Termination ................................................................................... 62 
15.11.1 
Planned Study Closure .................................................................................................... 62 
15.11.2 
Early Termination or Suspension .................................................................................... 62 
15.11.3 
Procedures for Termination or Suspension .................................................................... 63 
16. 
References .................................................................................................................... 64 
17. 
Appendices ................................................................................................................... 70 
18. 
Version History ............................................................................................................. 70 
 

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1. 
Glossary 
 
Term 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ASADE 
Anticipated Serious Adverse Device Effect 
BIPP 
Bismuth iodoform paraffin paste  
CEC 
Clinical Event Committee 
CFR 
Code of Federal Regulation 
CIP 
Clinical Investigation Plan 
CRO 
Clinical Research Organization 
CRS 
Chronic rhinosinusitis 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DD 
Device Deficiency 
DMC 
Data Monitoring Committee 
DoH 
Declaration of Helsinki 
DTL 
Delegated Task List 
eCRF 
Electronic Case Report Form 
EC/IRB/REB/Ethics Board 
Ethics Committee 
ENT 
Ear, nose, and throat  
ESS 
Endoscopic sinus surgery 
FAL 
Foreseeable Adverse Event List  

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Term 
Definition 
FD 
Financial Disclosure 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act 
FEDS 
Functional endoscopic dilation sinus surgery  
FESS 
Functional endoscopic sinus surgery 
GCP 
Good Clinical Practice 
HCL 
Hydrochloric acid 
HIPAA 
Health Insurance Portability and Accountability 
Act 
IB 
Investigator Brochure 
IC 
Informed Consent 
ICH 
International Conference of Harmonization 
IRB 
Institutional Review Board 
IFU 
Instructions For Use 
MDD 
Medical Device Directive 
MedDRA 
Medical Dictionary for Regulatory Activities 
MHLW 
Ministry of Health, Labour, and Welfare 
MN 
Minnesota 
MW 
Molecular weight 
NP 
Nasal polyposis or Nasal polyps 
NSR 
Non-Significant Risk 
OR 
Operating room 
PETG 
Polyethylene terephthalate glycol 
PHI 
Protected Health Information 

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Term 
Definition 
QoL 
Quality of Life 
RA 
Regulatory Authority 
REB 
Research Ethics Board 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SBS 
Solid Bleached Sulfate 
SC 
Steering Committee 
SNOT-22 
Sino-Nasal Outcome Test-22  
SR 
Significant Risk 
SID 
Subject Identification 
UAE 
Unavoidable Adverse Event 
US 
United States 
USP Grade 
United States Pharmacopeial Convention 
Standard 
 
Device Trademarks 
Novapak™ is a trademark of Medtronic Xomed, Jacksonville, FL, USA.  
 
 

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2. 
Synopsis 
Title 
Novapak Prospective Observational Clinical Trial 
Clinical Study Type 
Prospective, Observational, Case-Series, Post-Market, Clinical Trial  
Product Name 
Novapak Nasal Sinus Packing and Stent 
CS3600 and CS3900 
Sponsor  
Medtronic ENT 
6743 Southpoint Drive North; MS SS-54  
Jacksonville, FL 32216 
All funding for this study will be the responsibility of this sponsor. 
Local Sponsor 
Medtronic Canada ULC 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
1-905-460-3800 
Indication under 
investigation  
The Novapak Nasal Sinus Packing and Stent is intended for use in 
patients undergoing nasal/sinus surgery as a space-occupying stent 
to: 
• 
Separate tissue or structures compromised by surgical trauma. 
• 
Separate and prevent adhesions between mucosal surfaces in the 
nasal cavity. 
• 
Control minimal bleeding following surgery or trauma by 
tamponade effect, blood absorption, and platelet aggregation. 
• 
Act as an adjunct to aid in the natural healing process. 
Novapak Nasal Sinus Packing and Stent is indicated for use as a nasal 
packing to treat epistaxis. 
This study will be conducted in accordance with these indications. 
Investigation Purpose 
Obtain clinical data on the safety and effectiveness of the Novapak 
device under use as intended in the device indications. 
Product Status 
This study will be conducted in geographies where the Novapak 
device is commercially released.  
Primary Objective(s) and/or 
Endpoint(s)s 
The primary objective is to assess the safety of the Novapak Nasal 
Sinus Packing and Stent device used as indicated post-operatively in 
patients undergoing nasal/sinus surgery by: 
• 
Collecting all AEs directly attributed to the device and/or those 
that cannot be determined; and calculating a point estimate and 
confidence interval 
• 
Collecting all AEs and calculating an overall rate and safety profile 
for the device 
Secondary Objective(s) 
and/or Endpoint(s) 
The secondary objectives are to confirm device effectiveness during 
the procedure, 2 weeks and 1-month post treatment. 

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Study Design 
Prospective, observational, multi-site, non-controlled, non-
randomized, case-series, with a 2 week and 1-month follow-up in 
adults undergoing nasal/sinus surgery with Novapak Nasal Sinus 
Packing and Stent device used as indicated post-operatively 
Sample Size 
This study will include a minimum of 75 subjects. 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
1. Subject is at least 18 years of age. 
2. Subject undergoing nasal/sinus surgery with the intended need 
for nasal sinus packing (i.e., Novapak). 
3. After being informed of the nature of the study; the subject 
understands, agrees to its provisions, is willing to participate and 
provide written consent.  
4. Mentally stable and able to follow the instructions for self-
assessment/questionnaire completion. 
Exclusion Criteria 
1. Subject has a shellfish allergy. 
2. Subject has known bleeding disorder or prescribed 
anticoagulants. 
3. Subject has craniofacial abnormalities that may interfere with 
access to the sinuses. 
4. Subject is immunocompromised (e.g., taking immunosuppressive 
medication). 
5. Subject is participating in another investigational device, biologic, 
or drug study and has not completed the primary endpoint(s) or if 
there is a potential for clinical interference beyond the primary 
endpoint. 
Study Procedures and 
Assessments 
Visit 
Procedure 
Data Collection 
Pre-Surgery 
Inform subject about 
the study requirements 
Ask shellfish allergy 
questions  
Schedule surgery 
Consent document 
signed 
SNOT-22 (subject) 
Surgical 
Procedure 
(Day 0) 
 
Endoscopic exam 
Lund- Mackay Scores  
Lund-Kennedy Scores 
(baseline) 
Functional Endoscopic 
Sinus Surgery 
Other interventions if 
bleeding more than 
minimal 
 
Procedural Details 
Boezaart Surgical Field 
Grading Scale77 (pre-
packing) 
Boezaart Surgical Field 
Grading Scale77 (post-
packing)  

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Collect Adverse Events 
and/or device 
deficiencies 
Question: Bleeding 
controlled post 
packing?  
Day 1, 2, 3… 
Daily Irrigations 
Subject records 
volume / date 
Subject records any 
Adverse Events 
Day 14 (-2, +5) 
Office Visit 
Endoscopic exam 
Observe for residual 
product (remove) 
Debride Adhesions (if 
necessary) 
Review Subject 
Irrigations Records 
 
SNOT-22 (subject) 
Lund-Kennedy Scores 
Question: residual 
product?  
Score Adhesions 
(Valentine method44) 
Question: Bleeding 
controlled?  
Collect Adverse Events 
and/or device 
deficiencies 
Day 30 (-2, 
+12) 
Office Visit 
Endoscopic exam 
Debride Adhesions (if 
necessary) 
 
SNOT-22 (subject) 
Lund-Kennedy Scores 
Score Adhesions 
(Valentine method44)  
Collect Adverse Events 
and/or device 
deficiencies 
Safety Assessments 
Collect all AE observations and characterize those that are device 
related. 
 Statistics 
1. All continuous variables summarized as the number of subjects, 
means, standard deviations, medians, minimums, maximums, and 
interquartile ranges. 
2. Categorical variables will be summarized as frequencies and 
percentages.  
3. Analyses of the primary and secondary endpoints will be 
descriptive. 
 

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3. 
Introduction 
3.1 Background 
Chronic rhinosinusitis (CRS) affects millions of people each year,1,2 a condition defined as symptoms 
lasting for more than 12 weeks without complete resolution and with or without nasal polyps. 
Symptoms include inflammation of the nose and the paranasal sinuses with either nasal discharge or 
nasal blockage, obstruction, or congestion, with or without facial pain and/or pressure with or without 
reduction or loss of smell.3  In most cases, medical management is sufficient to relieve the symptoms, 
and if that should fail, surgical procedures are well-established. Approximately 250,000 sinus procedures 
are performed each year in the US to relieve acute rhinosinusitis (ARS) or CRS, most commonly known as 
functional endoscopic sinus surgery (FESS).1-3 
Dressing and packing devices in the ear, nose, and throat (ENT) and other procedures such as FESS are 
commonly used to absorb fluids during or after surgery, to improve and maintain hemostasis, to allow 
wounds to heal postoperatively, and/or when local measures have proven unsuccessful in controlling 
minor or severe epistaxis (bleeding). Dressings and packing products are some of the most common 
products used in surgeries. These types of dressing and packing products are placed in the affected area 
by physicians until sufficient pressure exists to tamponade the bleeding.4-11 The use of chitosan as a 
packing material has revealed several favorable biological properties (i.e., biocompatibility, 
biodegradability, low toxicity, and mucoadhesiveness), thus making this polymer a promising substrate 
for biomaterial medical devices. The general safety of chitosan has been found quite satisfactory in 
recent review articles.11-23 
Other efficacious and well-tolerated options are gauze, synthetic sponge packs, and balloon packing, 
which are the most conservative approaches to controlling any kind of bleeding.  Some products such as 
gauze or sponges can be coated with an antibiotic or a product such as bismuth iodoform paraffin paste 
(BIPP) to prevent infection.8-10,24-26  Variances in the devices (i.e. size, shape, attachment of a string) have 
been made to allow for convenient access to certain parts of the anatomy.  For example, standard gauze 
or sponges are used to treat bleeding in the anterior nasal area; however, epistaxis originating in the 
posterior nasal source would indicate the need for long ties attached to the gauze pack or sponges for 
easy removal.  An alternative device to posterior packing is a balloon catheter which can be inserted into 
the nasopharynx via the nostrils and inflated with sterile water.27,28  Over time, the balloon deflates and 
the volume drops, therefore it can remain in the cavity for up to 72 hours.  Most gauze and sponges 
used in patients with CRS or other procedures are removed within 48 hours, depending on the extent of 
the bleeding.5,6,24,29,30 
No consensus has been established about nasal splint or nasal packing choices and intranasal stay of 
nasal splints after surgery.31 Researchers have observed no difference in pain and the perception of 
nasal fullness or complications such as synechia, infection, hematoma, or perforations when nasal 
splints remained in place for 3, 5, or 7 days.31-33 Some data have suggested superior performance of 

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bioabsorbable (dissolvable) packs compared with non-absorbable packs with respect to patient comfort. 
For hemostasis and wound healing, variation in performance metrics makes interstudy comparison 
difficult.34-36 Weber (2001 and 2009) and Zhao (2013) confirm that <3 days of intranasal stay of nasal 
packing is non-influential on the surgical outcome and non-functional for prevention of adhesions. 32,33,37 
In order for wound healing to take place, a minimum of 5 to 7 days and up to 2 weeks with appropriate 
changing of dressing is recommended in other studies.38-40  
Medtronic Xomed has developed a nasal sinus stenting / packing material for use in post-sinus surgery, 
including ESS. Many new biomaterials have been developed to control hemostasis, reduce adhesion 
formation, and improve healing.  Several biomaterials are used for post-surgical nasal packing in the 
field of otorhinolaryngology including those that contain chitosan.41-44 Chitosan is a kind of natural 
polysaccharide that is widely exploited for biomedical applications due to its good biocompatibility, low 
immunogenicity and specific biological activities.45 Chitosan is derived from the shells of crustaceans 
(e.g., crab, shrimp), and has demonstrated biocompatibility and high biodegradability, including being 
easily excreted in the urine.12,14,21,42,43,45-47 Used for post-surgical nasal packing in the field of 
otorhinolaryngology, chitosan has been developed to control hemostasis and reduce adhesion 
formation and improve healing.12,15-18,20-22,41-43 Chitosan-based in situ gelling systems have already gained 
much attention as smart biomaterials in the development of several biomedical applications, such as for 
drug delivery systems and regeneration medicine.14,21,23,45,48  
Products made from chitosan have shown good hemostatic control and improved healing in animal and 
human studies. 28,41,42,44,49-54 Absorbable dressings for ENT surgery made with chitosan are Hemopore® 
Hemostatic Bioresorbable Nasal Dressing (Stryker Neuro Spine ENT, Kalamazoo, MI, USA), PosiSep™ and 
PosiSep™ X Intranasal Splints (Hemostasis, LLC, Saint Paul, MN, USA), and XeroGel® (Entellus Medical™, 
Plymouth, MN, USA).  Other non-chitosan-derived absorbable nasal dressings are MeroGel® Nasal 
Dressing and Sinus Stent (Anika Therapeutics, Inc., Bedford, MA, USA; Medtronic Xomed, Jacksonville, 
FL, USA), MeroPak® Bioresorbable Nasal Packing and Sinus Stent (Medtronic Xomed, Jacksonville, FL, 
USA), Nasastent® (Arthrocare Corporation, Austin, TX, USA), Surgicel® Original Absorbable Hemostat, 
Ethicon US, LLC, a J&J company, Cincinnati, OH, USA), Oxycel (Woundcare, Worcester, England), 
Stammberger Sinu-Foam® (Arthrocare ENT Corporation, Austin, TX, USA and Remscheid, Germany) Surgi 
shield (D. med, Seoul, South Korea), and NasoPore® (Stryker Neuro Spine ENT, Kalamazoo, MI, USA). It is 
important to note that in the literature, the term absorbable has been typically used interchangeably 
with the term dissolvable though most of these dressings do not absorb into local tissue. 
 
3.2 Purpose 
Medtronic, Inc. is sponsoring the Novapak Nasal Sinus Packing and Stent Study, a prospective, 
observational, multi-site, non-controlled, non-randomized, case-series, investigational, clinical study. 
The purpose of this study is to assess the safety of the Novapak Nasal Sinus Packing and Stent device 

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used as indicated post-operatively in patients undergoing nasal/sinus surgery. In addition, this study will 
observe some key measures of device effectiveness from the physician and subject perspective. 
The Novapak Nasal Sinus Packing and Stent study is being conducted as a non-significant risk post-
market investigational study in the US and Canada in accordance with Canadian local regulations and 
ISO 14155:2020 in support of EU MDR regulatory submission for a CE Mark. 
4. 
Objectives and/or Endpoints 
4.1 Objectives 
The study is being conducted to support the safety profile of the Novapak Nasal Sinus Packing and Stent 
device used as indicated post-operatively in patients undergoing nasal/sinus surgery. 
4.1.1 Primary Objective(s) 
The primary objectives of this study are to assess the safety profile of the Novapak Nasal Sinus Packing 
and Stent device used as indicated post-operatively in patients undergoing nasal/sinus surgery. 
4.1.1.1 Primary Study Endpoint(s) 
The study endpoints for safety will be: 
1) the statistical analysis of designated primary safety endpoint AEs that are directly attributable to 
the device and/or for which direct cause cannot be determined  
2) the rate of all AEs as defined below. Refer to Section 13 for more details regarding endpoint 
analysis. The data resulting from this study will be summarized in a final report generated by the 
Study Sponsor. 
4.1.1.1.1 
Primary Device Safety Endpoints 
The primary safety endpoint is an assessment of all AEs that are directly attributable to the device 
and/or for which cause cannot be determined, and that meet the definition of designated primary safety 
endpoint AEs (see section 11.4) that will be used to determine the point estimate and its confidence 
interval. This endpoint will be analyzed by calculating the point estimate with a confidence interval of its 
rate.  All AEs will be collected for each subject from time of treatment until their study completion. 
Study completion for each subject is the time point at which the 30-day follow-up visit is completed, 
outstanding AE follow-up (if any) has been concluded, and a Study Exit CRF has been completed.  For 
subjects who withdrew or were lost to follow-up, study completion will be the date of withdrawal or the 
date the subject meets the definition of lost to follow-up.  Refer to Section 13 for how missing data will 
be handled. 
4.1.1.1.2 
Secondary Safety Endpoint 
The secondary safety endpoint is the tabulation of all AEs (both device related AEs used in the primary 
safety endpoint and all other AEs) for the overall AE rate to establish a safety profile for use of the 

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Novapak device.  All AEs will be collected for each subject from time of treatment until their study 
completion. Study completion for each subject is the time-point at which the 30-day follow-up visit is 
completed, outstanding AE follow-up (if any) has been concluded, and a Study Exit CRF has been 
completed.  For subjects who withdrew or were lost to follow-up, study completion will be the date of 
withdrawal or the date the subject meets the definition of lost to follow-up.  Refer to Section 13 for how 
missing data will be handled. 
4.1.2 Secondary Objective(s) 
The secondary objectives of this study will gather data to support the effectiveness of Novapak’s 
inherent features and claims of performance: 
Adhesions – Sinus packing devices act as a space occupying stent to prevent raw tissues from contact 
and forming unwanted, obstructive tissue connections known as synechia or adhesions. This study will 
collect the number of adhesions observed by endoscopic examination as well as a grade of the 
adhesions based on the percentage of vertical height of the middle turbinate taken up by the adhesion. 
This data will be compared to historical data related to adhesions post sinus surgery. 
Control of bleeding – Sinus packing devices control bleeding by absorption and pressure on the bleeding 
surfaces known as the tamponade effect. Chitosan a component of Novapak also has hemostatic 
properties. This study will collect data related to post-operative bleeding. Since bleeding can be 
different for each subject and based on the extent of tissue trauma; a baseline observation immediately 
post-surgery using the Boezaart Surgical Field Grading Scale will be collected. After the packing is 
applied the surgical field will be graded again.  In addition, any residual bleeding will be observed and 
noted at the subject visits. 
Aid in healing – Novapak acts as an adjunct to aid in the natural healing process by providing a moist 
environment for the tissues during the proliferation phase of wound healing. In addition, the chitosan 
component within Novapak has hemostatic properties and is antibacterial to reduce unwanted 
microbial action which could lead to inflammation. The physician will grade the sinuses before surgery 
and then at each subject visit using the Lund-Kennedy scoring system.  In addition, the subjects will 
provide sinus health responses to the SNOT-22 questionnaire prior to surgery and again at each subject 
visit. 
Novapak is a dissolvable sinus packing device that under normal use with daily irrigation will be 
eliminated from the sinuses without the need for removal from the physician. An observation of residual 
Novapak will be done by the physician at each subject visit.  These observations will be compared to the 
subject’s compliance to daily irrigation.  

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5. 
Study Design 
Prospective, observational, multi-site, non-controlled, non-randomized, case-series, with adult subjects 
undergoing nasal/sinus surgery and using Novapak Nasal Sinus Packing and Stent device used as 
indicated post-operatively with 14-day and 30-day follow-up visits. The study is expected to be 
conducted at up to 5 study sites located in the US and/or Canada.  A minimum of 75 subjects will be 
enrolled in the study and one device is expected to be used per subject. Study sites that enroll faster 
than others will be allowed to do so in order to maintain an adequate enrollment rate; however, there is 
a site maximum enrollment of 60% (45 subjects) of the total enrollment. No known factors have been 
foreseen that may compromise the outcome of the clinical study or interpretation of the results. 
5.1 Duration 
The expected total study duration is approximately 9 months, based upon the following assumptions: 5 
months for subject enrollment, 1 month for last subject follow-up, and 3 months for data cleaning, 
analysis, and final report distribution.  The duration of individual subject participation will vary based on 
timing of study site enrollment procedures, review of eligibility criteria, and scheduling sinus surgery; 
however, at a minimum, participation of an individual subject will be at least 1 month. 
Site activation and initiation activities may take approximately 3 months prior to any subject enrollment 
but this may vary per site. 
5.2 Rationale 
This study is being conducted to support the safety and treatment effectiveness profile of the Medtronic 
Novapak Nasal Sinus Packing and Stent device as a post-surgical space-occupying stent for use in 
patients undergoing nasal/sinus surgery. The data from this study will support the claims stated in the 
product labeling related to adhesion prevention, control of minimal bleeding and acting as adjunct to aid 
in the natural healing process. 
The single-arm prospective design was chosen as the best option for obtaining the desired data. We 
rejected designs that use an inappropriate control device that is either non-dissolving, dissolves at a 
different rate or consistency, or a no treatment arm without packing. 
5.3 Study Oversight 
The study will utilize our internal ENT Medical Director, to advise on the scientific content of the study 
and provide input for the execution.  
6. 
Product Description 
6.1 General  
The Medtronic Novapak device is a single-use, nasal packing and stent for use following sinus surgery to 
prevent adhesions, control mild bleeding, and provide a level of antibacterial effectiveness. Novapak is 

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composed of formulated chitosan and cellulose ingredients that is lyophilized (freeze dried under 
vacuum) in a sponge form. The sponge can be compressed for insertion into anatomy and can be cut to 
size. 
The Novapak Nasal Sinus Packing and Stent device will be used within intended use as described in the 
IFU (document M977497A001 C) product labeling which is cleared under US FDA 510k regulations 
(K202623) and as per Health Canada License 103651 for Canada. 
The device is sterile, single-use, with duration of use at 7-14 days with adequate irrigation within a single 
surgery. No long-term use of the device is considered or indicated. 
Shelf-life is determined by the packaging materials and the materials of the device(s) and components 
within the device(s). The device and packaging are expected to be stable over extended periods of time. 
The Chitosan HCL material is derived from the exoskeleton (shell) of shellfish specifically from snow crab 
(Chinoecetes opilio).  The shells are deproteinized, decalcified and deacetylated; the final product 
Chitosan HCL is deemed non-viable.   
The Novapak sponge is intended for use in patients undergoing nasal/sinus surgery as a space occupying 
packing and is intended for single use for 7-14 days with adequate irrigation. Novapak is also an invasive 
non-implantable device (Table 1). 
Table 1: Materials in Contact with Tissues and/or Body Fluids 
Device 
Use 
Invasive/ 
Non-
invasive 
Implantable/ 
Non-
implantable 
Duration 
of use 
Contact 
with 
Body 
Body 
Contact 
Materials 
CS3600 
Novapak, 
standard 
Single use / 
dissolvable 
Invasive 
Non-
implantable 
7-14 
days 
with 
adequate 
irrigation 
Yes 
Nasal 
cavity 
Chitosan HCL;  
Cellulose – sponge 
scaffolding  
CS3900 
Novapak, 
firm 
Single use / 
dissolvable 
Invasive 
Non-
implantable 
7-14 
days 
with 
adequate 
irrigation 
Yes 
Nasal 
cavity 
Chitosan HCL;  
Cellulose – sponge 
scaffolding  
 
Novapak hydrates with sterile saline and forms a gel. The sponge dissolves within the nasal cavity with 
daily irrigation and natural mucus flow over several days.  Residence time is typically 7-14 days with 
adequate irrigation.  Alternately, the dressing may be removed through gentle aspiration at the 
discretion of the physician.  Figure 1 depicts the Novapak Sponge (8 cm long by 1.8 cm wide and 1.3 cm 
tall).  

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Figure 1: Novapak Sponge (photo of 2 sponges) 
 
Class of Device: Class I sterile (US FDA); Class II (Canada); Class III sterile (EU MDR) 
Device Identifier: 20643169662241 (for CFN CS3600-10), 20643169662227 (for CFN CS3600-2), 
20643169662258 (for CFN CS3900-10), 20643169662234(for CFN CS3900-2) 
Device CFNs: Novapak Standard (CS3600); Novapak Firm (CS3900) 
Device or therapy or technology group the device belongs to: ENT Tissue Health 
The study will be conducted using the products/components described in the table below. Instructions 
for use of the devices used in this study are provided in their respective manuals or IB. As a fully 
commercially released medical device, Novapak has undergone required verification and validation 
testing as well as biocompatibility testing in accordance with ISO 10993-1:2018. 
Table 2: System Product / Component Information 
Model Number 
(CFN)  
Component (Manufacturer) 
Investigational or Market-released 
CS3600 
Novapak Standard 
Market released 
CS3900 
Novapak Firm 
Market released 
6.2 Dosage Form and Route of Administration 
The Novapak Nasal Sinus Packing and Stent is applied to the internal nasal passages by direct insertion 
through the nasal opening. It may be compressed and or folded to a thin sheet and trimmed before 
insertion to fit an individual anatomy. It will absorb body fluids in the immediate area of insertion and 
should be hydrated with sterile surgical irrigation fluid (i.e., Saline) to fully form the sponge.   

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6.3 Manufacturer 
The following table contains the manufacturer details. 
Table 3: Manufacturer Contact Details 
Name of the Device  
Medtronic Novapak Nasal Sinus Packing and Stent 
Legal Manufacturer 
Medtronic ENT 
6743 Southpoint Dr. North 
Jacksonville, FL 32216 USA 
6.4 Packaging 
The primary packaging for each Novapak Nasal Sinus Packing and Stent device consists of a 
thermoformed PETG tray sealed to a non-porous foil lid. These sealed tray assemblies are packaged and 
sold in SBS paperboard cartons in packs of two or ten devices for both the standard and firm device 
formulation. A SBS paperboard insert is used to organize and protect the trays within the sales unit 
carton. Each sealed tray and sales unit carton is labeled with a paper-based adhesive label printed with 
resin-based black ink. Each sales unit carton includes a paper instruction for use (IFU) document and is 
sealed closed with a blank, paper-based adhesive label. 
Study product is available commercially and as such, current labeling for the study product and 
reference/technical manual(s) where clinical indications and contraindications for use and any cautions 
and warnings can be found in the Instructions for Use provided with the devices. 

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Figure 2 Example of Product Inner Label 
 
6.5 Intended Population 
The Medtronic Novapak nasal packing and stent is indicated for use in adults following sinus surgery to 
prevent adhesions, control mild bleeding, and provide a level of antibacterial effectiveness. 
6.6 Equipment 
The following equipment must be available at each study site to support study activities: 
• 
Nasal Endoscope (used for physician examination of the subject sinus tissues) 
No monitoring, maintenance or calibration is required for a nasal endoscope. 
 
The Novapak Nasal Sinus Packing and Stent device is commercially available; therefore, devices used in 
this study will be taken from the stock shelves of each individual site. In this study, the devices are being 
used according to their cleared indications. Disposition management of all device inventories by 
investigational sites will be in accordance with their respective operating policies, this protocol and 
applicable regulatory agency regulations.  

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6.7 Product Use 
The Medtronic Novapak Cellulose/Chitosan stent (sponge) is provided as a dry sponge which can be 
compressed to fit into anatomy and can be hydrated (before or after insertion) with saline.  The stent 
shall degrade and dissolve away within 1-2 weeks (CS3600 ~1 week, CS3900 ~2 weeks) via bio-erosion 
into a gel.  Novapak sponge (CS3600 & CS3900) is manufactured using a lipolyzed process. Packaged 
product is sterilized via E-Beam. Medtronic Xomed Jacksonville facility controls inventory storage, and 
release.  
The Novapak material provides stenting of the middle meatus of the nasal cavity by physically 
separating the tissue surfaces (See anatomy in Figure 3) and preventing adhesion formation. The 
Novapak material controls minimal bleeding and oozing of the debrided mucosal surfaces via 
tamponade effect, blood absorption and platelet aggregation as a result of material application. The 
hemostatic properties are a known characteristic of chitosan materials.12,28,44,54-65 The Novapak material 
provides a moist environment which aids in the healing process post-surgery. In addition, Novapak has 
demonstrated a level of antibacterial effectiveness during in vitro testing.14,42,66-72  The main component 
in Novapak is Chitosan HCL, which is a cationic biopolymer with inherent properties that make it 
antimicrobial. The gel forms an antibacterial barrier at the wound site, thus preventing both bacterial 
growth on the device and the penetration of microbes.73 The method of elimination of the Novapak 
material is via hydrolysis during irrigation, and is expelled from the body via swallowing and ingestion or 
through the nares. 
 
 
Figure 3: Anatomy of Application Site 
 

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6.8 Product Training Materials 
This device is intended for use by healthcare practitioners trained in the treatment described in the 
indications for use. No specific device use training is required or expected for the healthcare 
practitioners participating in this study. 
6.9 Product Storage 
Since Novapak is a commercially released product, it is the responsibility of the investigator to correctly 
handle, and store, products maintained at the study site according to the IFU. 
6.10 Product Return 
No product will be returned to Medtronic. 
6.11 Product Accountability 
Product delivery: 
Commercially available product supply will be managed in a manner consistent with other market-
released products. 
Product receipt and tracking:  
All products used in this study will be market released in the geographies they are used. If there are 
additional local requirements related to the  Novapak Nasal Sinus Packing and Stent device beyond what 
is collected by Medtronic on the eCRF, this is the Investigator’s responsibility and should be recorded in 
the subject’s medical records, but will not be collected by Medtronic (e.g., national registration card 
number, identification code linked to names and contact information, log of all subjects enrolled in the 
study, lot or batch number).  
7. 
Study Site Requirements 
7.1 Investigator/Investigation Site Selection 
All investigators managing the subject’s sinus and upper airway health must be qualified practitioners 
and experienced in the diagnosis and treatment of subjects with sinus disease. All ENT physicians must 
be experienced and/or trained in the handling of Medtronic Novapak. 
The role of the principal investigator is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety and well-being of the subjects 
involved in the clinical investigation. 
The principal investigator shall: 
• 
Be qualified by education, training, and experience to assume responsibility for the proper conduct 
of the clinical investigation 

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• 
Be experienced in the field of otorhinolaryngology, sinus surgery and the application nasal sinus 
packing and stenting (e.g., use of Medtronic Novapak) 
• 
Disclose potential conflicts of interest, including financial, that interfere with the conduct of the 
clinical investigation or interpretation of results 
• 
Be able to demonstrate that the proposed investigational study site: 
− Has an adequate pool of eligible subjects within the recruitment period 
− Has one or more qualified investigators, a qualified investigational study site team and adequate 
facilities for the foreseen duration of the clinical investigation 
Study site personnel training will be completed and documented prior to participation in this study. 
7.2 Study Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train study site personnel on 
the clinical investigation plan, informed consent, and on data collection and reporting tools. If new 
members join the study site team, they will receive training on the applicable study requirements 
relevant to their role before contributing to the study. 
Prior to performing study related activities, all regulatory requirements shall be fulfilled, including, but 
not limited to the following:  
• 
IRB/REB approval (and voting list, as required by local law) of the current version of the CIP and IC.  
• 
RA approval or notification (as required per local law)  
• 
Fully executed CTA  
• 
Financial disclosure (if applicable)  
• 
CV of investigators and key members of the investigation study site team (as required). The 
signature on the CV must be dated within 3 years prior to the date of activation of the study site.   
• 
Documentation of delegated tasks 
• 
Documentation of study training.  
 
Additional requirements imposed by local regulations, the IRB/REB and RA shall be followed, if 
appropriate.  
In addition, all participating study site staff must be trained on the current version of the CIP as well as 
on the applicable study requirements depending on their role and must be delegated by the principal 
investigator to perform study related activities.   
Medtronic will provide each study site with documentation of study site/investigator readiness; this 
letter must be received prior to performing study related activities. 

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7.3 Role of the Sponsor Representatives 
In addition to performing monitoring and auditing activities, sponsor representatives may provide 
support at the study site as required for the study under supervision of the Principal Investigator, 
including: 
• 
Provide study training relevant and pertinent to the involvement of personnel conducting study 
activities and investigator responsibilities 
• 
Technical support at the site visits under the supervision of a study investigator, but no data entry, 
shall be performed by Medtronic personnel or their representatives at study sites 
Sponsor representatives that provide study support will be documented on the site’s Sponsor Technical 
Support list. 
8. 
Selection of Subjects 
8.1 Study Population 
A sample size was selected that is adequate to assess the safety and treatment effectiveness of the 
Medtronic Novapak Nasal Sinus Packing and Stent device. The sample size is not based on a formal 
power calculation; however, results from no fewer than 75 subjects and one device used per subject are 
expected to provide sufficient evidence that the Medtronic Novapak does not introduce new 
complications or increase severity or likelihood of occurrence of existing complications in this 
population. It is anticipated that there may be subjects who will not receive nasal packing for any reason 
after enrollment (including withdrawal prior to treatment).  Based on literature, it is expected that an 
average of one sinus per subject will be treated. Thus, if all 75 subjects have one sinus treated, data will 
be collected for approximately 75 sinuses. Note: all sinuses requiring treatment will be treated, 75 
sinuses are the minimum number required for the protocol, but additional sinus data is likely.  
In relationship to this unilateral or bilateral treatment, the number of devices used could be one or two 
per subject. Therefore, total product used in this study would be a minimum of 70 if a single device is 
used, to approximately 150 if two devices are used per subject. Note: Physicians are free to modify the 
size and shape of the device to fit in a unique individual anatomy. 
8.2 Subject Enrollment 
Enrollment of the subject will occur after the subject is screened for eligibility, informed of the study 
requirements and the subject signs the informed consent. 
When a subject and the principal investigator or authorized designee, as required, have personally 
signed and dated the IC, the subject is considered a subject enrolled in the study. The date the subject 
signed the IC and data protection authorization if applicable must be documented in the subject’s 
medical records.  
Subjects will be recruited from the practices and clinics of the participating Study Investigators or from 
other non-investigator Otolaryngologist or Rhinologist physician referrals. Potential subjects will have 

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the need to undergo nasal/sinus surgery using a space-occupying stent. Subjects may continue their 
medical therapy regimen (antibiotics, steroids, nasal sprays, etc) per their treating physician.  
All subjects will be screened for study eligibility. A qualified member of the investigational site’s research 
team will review the inclusion and exclusion criteria to screen each subject. 
There will be no minimum number of subjects enrolled at a site, no site will enroll greater than 60% (45 
subjects) of the total enrollment goal. This numerical goal is to ensure a diversity of experience and 
surgical techniques throughout the study, while allowing flexibly of enrollment based on eligible 
populations of subjects. 
Subjects will be considered enrolled into the study when they have: 
• 
Been informed of the study design, objectives, risks and benefits 
• 
Met the eligibility criteria 
• 
Confirmed interest in participation by signing a written Informed Consent and Research 
Authorization Form 
8.3 Inclusion Criteria 
• 
Subject is at least 18 years of age. 
• 
Subject has the need to undergo nasal/sinus surgery with the intended need for nasal sinus packing 
(i.e., Novapak). 
• 
After being informed of the nature of the study; the subject understands, agrees to its provisions, is 
willing to participate and provide written consent.  
• 
Mentally stable and able to follow the instructions for self-assessment/questionnaire completion. 
8.4 Exclusion Criteria 
• 
Subject has a shellfish allergy. 
• 
Subject has known bleeding disorder or prescribed anticoagulants. 
• 
Subject has craniofacial abnormalities that may interfere with access to the sinuses. 
• 
Subject is immunocompromised (e.g., taking immunosuppressive medication). 
• 
Subject is participating in another investigational device, biologic, or drug study and has not 
completed the primary endpoint(s) or if there is a potential for clinical interference beyond the 
primary endpoint. 
9. 
Study Procedures 
The subjects will encounter the following procedures during their participation in the study: 
• 
Lund-MacKay Scores (pre-surgical history) 
• 
Lund-Kennedy Score (pre-surgery, 14, 30) 
• 
SNOT-22 questionnaire (pre-surgery, 14, 30) 

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• 
Endoscopic Exams (day 0, 14, 30) 
• 
Functional Endoscopic Sinus Surgery (day 0) 
• 
Insertion of the Novapak device in the nasal cavity (day 0) 
• 
Post – Surgical Daily saline irrigations (day 1 through day 14 + longer if prescribed by physician) 
• 
Debridement of adhesions at day 14 and/or day 30 (if necessary) 
• 
Removal of residual product at day 14 (if necessary) 
A patient needing sinus surgery with the use of dissolvable packing would encounter all or most of these 
procedures during the course of treatment. 
 
9.1 Schedule of Events 
Table 4: Planned Visits, Procedural Events and Data Collection 
Visit 
Procedure 
Data Collection 
Pre-Surgery  
Inform subject about the study 
requirements 
Ask shellfish allergy questions 
Schedule Surgery 
Consent document signed 
SNOT-22 (subject) 
Day 0 
 
Endoscopic exam 
Lund-MacKay Scores 
Lund-Kennedy Scores (baseline) 
Functional Endoscopic Sinus Surgery 
Other interventions if bleeding more 
than minimal 
 
Procedural Details  
Boezaart Surgical Field Grading Scale 
(pre-packing) 
Boezaart Surgical Field Grading Scale 
(post-packing) 
Question: Bleeding controlled post 
packing?  
Collect Adverse Events and/or Device 
Deficiencies 
Day 1, 2, 3… 
Daily Irrigations 
Subject records volume / date 
Subject records any Adverse Events 
Day 14 (-2, +5) 
Office Visit 
Endoscopic exam 
Observe for residual product 
(remove) 
Debride Adhesions (if necessary) 
Review Subject Irrigations Records 
 
SNOT-22 (subject) 
Lund-Kennedy Scores 
Question: residual product?  
Score Adhesions (Valentine method) 
Question: Bleeding controlled? Collect 
Adverse Events and/or Device 
Deficiencies 
Day 30 (-2, +12) 
Office Visit 
Endoscopic exam 
Debride Adhesions (if necessary) 
SNOT-22 (subject) 
Lund-Kennedy Scores 

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Review Subject Irrigations Records 
 
Score Adhesions (Valentine method) 
Collect Adverse Events and/or Device 
Deficiencies 
9.2 Data Collection 
Please refer to the Case Report Form Instructions for details regarding directions on completing CRFs, 
allowable data on CRFs, and source document requirements.  Table 5 shows the schedule on which CRFs 
are to be completed by designated investigational personnel. 
Table 5: Schedule for Completion of CRFs 
CRF 
Phase of Protocol 
 
Enrollment/ 
Screening 
Procedure 
Follow Up  
Other 
Screening/Baseline 
X 
 
 
 
Application 
 
X 
 
 
Visit 1 / Visit 2 
 
 
X 
 
Adverse Event 
 
X* 
X* 
X* 
Device Deficiencies 
 
X* 
X* 
X* 
Study Exit 
X* 
X* 
X* 
X* 
Protocol Deviation Form 
X* 
X* 
X* 
X* 
*Adverse Events, Device Deficiencies, Protocol Deviations, and Study Exit CRFs should be completed at any time point in 
which the corresponding events occur. 
9.3 Scheduled Follow-up Visit Windows 
After receiving notice of successful implantation/device application, Medtronic will provide the target 
dates and windows for each subject’s visits to the study site if applicable. Should a subject miss a visit or 
the visit fall outside the pre-specified window, a study deviation must be reported, and the original 
follow-up schedule maintained for subsequent visits.  
Data analyses include follow-up visits, regardless of whether the visit occurs within the window.   
Therefore, a late visit is preferred over a missed visit but must be accompanied by a deviation report. 
Follow-up visit windows are listed in Table 6 and are based on days post-implant.  

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Table 6: Data collection and study procedure requirements at subject visits 
Study Follow-up 
Visit 
Window (Calculated days post-surgery) 
Window Start 
(days post-surgery) 
Target 
(days post-surgery) 
Window End 
(days post-surgery) 
1.  Day 14 (-2, +5) 
12 
14 
19 
2.  Day 30 (-2, +12) 
28 
30 
42 
9.4 Subject Screening 
All subjects that are considered for the study should be screened based on the inclusion/exclusion 
criteria. The reason for non-eligibility, as determined by the Investigator should also be recorded on 
appropriate eligibility eCRF. The screening information serves as a method for Medtronic to assess 
selection bias in the trial and other reasons for subject rejection (e.g., subject with a known shellfish 
allergy). Additional shellfish allergy criteria questions have been added to determine the potential 
subjects’ eligibility based on their previous exposure risk to shellfish and other organisms containing the 
tropomyosin protein. If the potential subject is completely naïve to shellfish allergic status the site 
primary investigator will assess the risk based on responses to screening questions and may either 
include, exclude or test the subject for shellfish allergy potential. 
9.5 Prior and Concomitant Medications/Therapies 
Subjects that are immunocompromised and/or are taking immunosuppressive medication are not 
eligible for this study. There are no other medication/therapy restrictions in the study unless they are 
investigational and may confound the study results, in which case, prior approval would be needed from 
Medtronic. 
9.6 Subject Consent 
Informed consent is defined as a legally effective documented confirmation of a subject’s (or their 
legally authorized/designated representative or guardian) voluntary agreement to participate in a 
particular study after information has been given and explained to the subject on all aspects of the study 
that are relevant to the subject’s decision to participate. This process includes obtaining an IC form (and 
where required, a/an Authorization to Use and Disclose Personal Health Information/Research 
Authorization/other privacy language as required by law) that has been approved by Medtronic and the 
study IRB/REB (specific study site or central IRB/REB where authorized) and signed and dated by the 
subject (or their legally authorized/designated representative or guardian). A subject may only consent 
after information has been given and explained to the subject on all aspects of the clinical investigation 
that are relevant to the subject’s decision to participate. IC may be given by the legally 

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authorized/designated representative only if a subject is unable to make the decision to participate in a 
clinical investigation. In such cases, the subject shall also be informed about the clinical investigation 
within his/her ability to understand. 
The template IC will be provided under separate cover. Prior to enrolling subjects, the IC site (and where 
required the Authorization to Use and Disclose Personal Health Information/Research 
Authorization/other privacy language as required by law) must be approved by Medtronic and the 
IRB/REB.  The document(s) must be controlled (i.e. versioned and dated) to ensure it is clear which 
version(s) were approved by the IRB/REB.  Any adaptation of the sample IC must be reviewed and 
approved by Medtronic and the IRB/REB reviewing the application prior to enrolling subjects.  
The investigator must notify the subject (or their legally-authorized/designated representative or 
guardian) of any significant new findings about the study that become available during the course of the 
study which are pertinent to the safety and well-being of the subject, as this could impact a subject’s 
willingness to participate in the study. If relevant, consent may be requested from subjects to confirm 
their continued participation. 
Prior to initiation of any study-specific procedures, IC must be obtained from the subject (or their legally 
authorized/designated representative or guardian). Likewise, privacy or health information protection 
regulation may require subjects to sign additional forms to authorize study sites to submit subject 
information to the study sponsor. The IC process must be conducted by the principal investigator or an 
authorized designee, and the IC Form (and where required, Authorization to Use and Disclose Personal 
Health Information/Research Authorization/other privacy language as required by law) must be given to 
the subject (or their legally authorized/designated representative or guardian) in a language he/she is 
able to read and understand. The process of IC must be conducted without using coercion or undue 
improper influence on or inducement of the subject to participate by the investigator or other study site 
personnel. The IC process shall not waive or appear to waive subject’s legal right. The language used 
shall be as non-technical as possible and must be understandable to the subject and the impartial 
witness, where applicable.  
The subject must have ample time and opportunity to read and understand the IC form, to inquire about 
details of the study, and to decide whether or not to participate in the study. All questions about the 
study should be answered to the satisfaction of the subject. 
When the subject decides to participate in the study, the IC must be signed and personally dated by the 
subject and investigator or authorized designee, as required by the IC, and ensured by the principal 
investigator or his/her authorized designee.  
A copy of the IC (and where required, the Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language), signed and dated as required by law, must 
be provided to the subject and his/her authorized designee.  

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If the IC is obtained the same day the subject begins participating in study-related procedures, it must 
be documented in the subject’s case history that consent was obtained prior to participation in any 
study-related procedures. It is best practice for the IC process to be documented in the subject’s case 
history, regardless of circumstance. 
In the event the subject or legally designated representative cannot read and/or write, the IC process 
shall be obtained through a supervised oral process. An independent and impartial witness must be 
present during this process. The IC and any other information must be read aloud to the prospective 
subject or his/her legally designated representative. Whenever possible, either the subject or his/her 
legally designated representative shall sign and personally date the informed consent form. The witness 
signs and personally dates the IC attesting that the information was accurately explained and that 
informed consent was freely given. 
The original of the signed IC must be filed in the hospital/clinical chart and/or with the subject’s study 
documents.  
The IC (and where required, Authorization to Use and Disclose Personal Health Information/Research 
Authorization/other privacy language as required by law) must be available for monitoring and auditing.  
9.7 Enrollment 
A subject is considered enrolled when the consent process has been finalized. The date the subject (or 
the subject’s authorized/designated representative or guardian) signed the IC and Data Protection 
Authorization, as required by law, must be documented in the subject’s medical records. A log of all 
subjects enrolled in the study should be maintained. Once consent is obtained, report adverse 
events/deaths, device deficiencies, study deviations and subject exits as they occur. 
After completion of study-related training, designated study personnel may conduct a preliminary 
assessment of subjects for enrollment into the study. The potential study candidate will be interviewed 
for their interest in the study and willingness to comply with the study protocol.  If the potential study 
subject is interested and willing to comply, they will be asked to sign the Informed Consent and 
Research Authorization Form.  Upon signing, study personnel will confirm eligibility based on study 
inclusion and exclusion criteria and will collect baseline information such as: 
• 
Demographics – including date of birth, age, gender, ethnicity  
• 
Medical history including previous interventions and disease state 
 
Subjects who do not meet the eligibility criteria or decline study participation will be considered screen 
failures. Screen-failed subjects, including reason for exclusion, will be documented on the Screening and 
Enrollment Log. 

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9.8 Surgical Procedure 
On the day of the Sinus Surgical Procedure the subject should be scheduled giving enough time for study 
procedures and data collection prior to surgical procedures. 
The following information is required to be collected at the surgical procedure visit: 
• 
Lund-MacKay Scores (pre-surgical history) 
• 
Subject completes the baseline SNOT-22 questionnaire   
• 
Physician conducts Endoscopic Examination pre-surgery and grades the sinuses using Lund Kennedy 
Scores 
• 
Surgical Information: Date of surgery, the surgical location (left, right or both nasal cavities), type of 
surgery (e.g. turbinectomy, septoplasty, FESS, etc.) 
• 
Collect any Adverse Events and/or device deficiencies 
• 
Physician grades bleeding post-surgery and before packing is inserted using the Boezaart Surgical 
Field Grading Scale 
• 
Physician grades bleeding post-surgery and after packing is inserted using the Boezaart Surgical Field 
Grading Scale 
• 
The type of Novapak used and lot number(s) 
 
Subjects may be treated with the Novapak device unilaterally or bilaterally, the number of devices used 
could be one or two per subject. Therefore, total product used in this study would be a minimum of 75 if 
a single device is used, to approximately 150 if two devices are used per subject. Note: Physicians are 
free to modify the size and shape of the device to fit in a unique individual anatomy. 
9.9 Scheduled Follow-up Visits 
Scheduled visits will occur at day 14 and day 30 post-surgical procedure. 
The following information is required to be collected at follow-up visits: 
Day 14 visit 
• 
Subject turns in daily irrigations log 
• 
Subject completes the visit SNOT-22 questionnaire 
• 
Collect any Adverse Events and/or device deficiencies 
• 
Physician conducts Endoscopic Examination and grades the sinuses using Lund Kennedy 
Scores 
• 
Physician conducts adhesion scores and grades the sinuses using the method of Valentine 
• 
Physician debrided adhesions (if necessary) 
• 
Physician removes residual Novapak product if present in the sinuses 
• 
Physician notes any bleeding observed at this examination 
Day 30 visit 
• 
Subject completes the visit SNOT-22 questionnaire 

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• 
Collect any Adverse Events and/or device deficiencies 
• 
Physician conducts Endoscopic Examination and grades the sinuses using Lund Kennedy 
Scores 
• 
Physician conducts adhesion scores and grades the sinuses using the method of Valentine 
• 
Physician debrided adhesions (if necessary) 
9.10 Unscheduled Follow-up Visits 
If a subject returns to the Investigator outside the scheduled follow-up visit window, the Investigator 
will evaluate the subject according to existing standard of care methods. The reason for the 
unscheduled follow-up visit will be recorded on the Follow-Up eCRF. Adverse events that present at the 
time of the visit will also be recorded on the Adverse Event eCRF. Device Deficiencies that present at the 
time of the visit will also be recorded on the Device Deficiencies eCRF. 
Upon the follow-up assessment, the designated study personnel will record the following information: 
• 
Date of Visit 
• 
Reason for unscheduled visit 
• 
Observations from standard of care medical evaluation 
• 
Adverse Events and/or device deficiencies, if applicable 
9.11 SNOT-22 Questionnaires 
The Sino-Nasal Outcome Test (SNOT-22) is a standardized questionnaire given to assess the subject’s 
severity of symptoms related to their nasal sinuses.  The questionnaire will be administered to each 
subject prior to surgery and then again at day 14 and day 30 visits. A progression in improvement of the 
scores would indicate that the surgical procedure was successful and the packing material did not hinder 
this improvement. 
9.12 Irrigation Compliance 
In order for the Novapak to perform effectively and to fully dissolve as intended the subjects must 
irrigate their sinuses daily with a saline solution. The subjects will be given a sinus rinse kit with 
instructions.  The kit includes a plastic bottle and packets of Sodium Chloride & Sodium Bicarbonate 
(USP Grade) which the subjects will make the saline solution using distilled water. 
The subjects will log the total daily volume and date of each irrigation.  The site coordinator will collect 
this log at day 14 and inspect for completeness. The number of days where irrigation was done and 
volume will be recorded. 
9.13 Assessment of Efficacy 
The following parameters will be used to assess the effectiveness of the Novapak device used according 
to device indications:  
Adhesions – in order to show that Novapak acts a nasal stent to separate tissue or structures 
compromised by surgical trauma and separate and prevent adhesions between mucosal surfaces in the 
nasal cavity the study physician will count the number of adhesions present and grade the sinuses using 
the ordinal scale method published by Valentine 2010. 

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Control of bleeding – in order to show that Novapak controls minimal bleeding the study physician will 
grade the bleeding post-surgery and prior to packing using the Boezaart Surgical Field Grading Scale.  
After inserting the Novapak product with irrigation to hydrate the product the bleeding will be graded 
again using the same scale.   
During the day 14 visit the physician will be asked if any bleeding is observed during the exam and prior 
to any debridement procedure. 
Progression of healing – The Lund Kennedy endoscopic grading system will be used to show that 
Novapak acts as an adjunct to aid in the natural healing process.  The physician will perform an 
endoscopic exam prior to surgery (to establish a baseline), at day 14 and day 30 visits (to show 
progressive healing). 
Residual Novapak – Novapak dissolves naturally with daily irrigation. Any residual Novapak in the nasal 
cavity will be recorded at the 14 day visit and compared to the subject compliance to the daily irrigation 
log. 
9.14 Assessment of Safety 
AE information is collected in this study. See Section 11 for further information on the collection of AEs 
and safety information. 
9.15 Recording Data 
Data entered must be traceable to source documents. Source documentation is defined as the first time 
data appear, and may include original documents, data, and records (e.g., hospital records, clinical and 
office charts, procedure reports, laboratory notes, memoranda, subjects’ diaries or evaluation 
checklists, pharmacy dispensing records, recorded data from automated instruments, copies or 
transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, 
microfilm or magnetic media, X-rays, subject files, device data and records kept at the pharmacy, at the 
laboratories and at medico-technical departments involved in the study). 
In general, eCRFs (or paper copies) may not serve as source documents. An exception may be the 
completed SNOT-22 Questionnaires and endoscopic grading worksheets. Source documentation for data 
elements not routinely captured in medical records may vary from study site to study site; the study site 
may use source document worksheets if identified as source documents. 
The investigator must ensure the availability of source documents from which the information on the 
eCRFs was derived. The type and location of source documents should be documented. Where printouts 
of electronic medical records, are provided as source documents, or where copies of source documents 
are retained as source documents, those should be certified. Certification must contain (1) the signature 
of the individual making the copy, (2) the date the copy was made and (3) a statement attesting to the 
accuracy and completeness of the copy.  
The source documents must be made available for monitoring, safety data review or auditing by 
Medtronic’s representative or representatives of the competent authorities and other applicable 
regulatory agencies. 

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The CRF may be considered source for the following data collection elements: 
• 
Enrollment Notification 
− Study site assigned subject reference 
• 
Baseline 
− Administrative information 
• 
AE eCRF 
− Date study site became aware of event 
− Relatedness of adverse event 
• 
DD eCRF 
− Date study site became aware of event 
• 
Deviations 
− Reason for deviation 
• 
Device Disposition Log 
9.16 Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the CIP or the 
CTA. 
Prior approval by Medtronic is expected in situations where the investigator anticipates, contemplates, 
or makes a conscious decision to deviate. Prior approval is not required when a deviation is necessary to 
protect the safety, rights or well-being of a subject in an emergency or in unforeseen situations beyond 
the investigator’s control (e.g. subject failure to attend scheduled follow-up visits, inadvertent loss of 
data due to computer malfunction, inability to perform required procedures due to subject illness). 
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward. 
This may also apply for other unforeseen situations (e.g. the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary end point analysis). However, 
prior approval from Medtronic is required for such situations.  
All study deviations must be reported on the CRF regardless of whether medically justifiable, pre-
approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an emergency. 
Multiple deviations of the same type at the same visit may be reported on one case report form. 
In the event the deviation involves a failure to obtain a subject’s consent or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to the IRB/REB as well 
as Medtronic within five (5) working days. Reporting of all other study deviations should comply with 
IRB/REB policies and/or local laws and must be reported to Medtronic as soon as possible upon the 
study site becoming aware of the deviation. Reporting of deviations must comply with IRB/REB policies, 

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local laws, and/or RA requirements.  Refer to Investigator Reports, Section 15.9.1 for geography-specific 
deviation reporting requirements and timeframes for reporting to Medtronic and/or RAs.  
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the CIP, conduct additional training, 
terminate the investigation). Repetitive or serious investigator compliance issues may result in initiation 
of a corrective action plan with the investigator and study site, and in some cases, may necessitate 
suspending enrollment until the problem is resolved or ultimately terminating the investigator's 
participation in the study. Medtronic will provide study site-specific reports to investigators summarizing 
information on deviations that occurred at the investigational study site as needed.  
Examples of study deviations include but are not limited to: 
• 
Failure to obtain proper IC 
• 
Failure to collect required study data  
• 
Inclusion/exclusion criteria not met 
• 
Visit conducted outside of scheduled visit window 
• 
Device not used per labeling 
9.17 Subject Exit, Withdrawal or Discontinuation 
Should a subject withdraw or be lost to follow-up, the designated study personnel will complete the 
Study Exit CRF, including: 
• 
Date of Study Exit 
• 
Subject status (i.e., reason for withdrawal) 
 
At any time between enrollment and study completion, study personnel may complete the Study Exit 
CRF. The number (minimum 2) and type of attempts to contact subject (email, text, call, etc.) prior to 
Lost to Follow-up designation should be documented in the subject’s medical record. 
9.17.1 
Study Exit 
A study exit eCRF is required for all subjects. Prior to exiting a subject from the study, it is recommended 
to follow the subject until all ongoing system and/or procedure related AEs are resolved or unresolved 
with no further actions planned.  Following exit, subjects will continue to receive standard medical care.  
Upon exiting from the study, no further study data will be collected or study visits will occur for the 
subject.  All data available through the time of the subject’s exit will be used for analysis.  
Subjects are urged to remain in the study as long as possible but may be exited from the study for any of 
the following situations: 
• 
Study completed 
• 
Subject lost to follow-up 

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• 
Subject death 
• 
Subject did not meet inclusion/exclusion criteria  
• 
Investigator chose not to use the Novapak Nasal Sinus Packing and Stent device 
• 
Subject did not provide consent (or data use protection authorization where required) 
• 
Subject chooses to withdraw (e.g., consent withdrawal, relocation to another geographic location)  
• 
Investigator deems withdrawal necessary (e.g., medically justified, inclusion/exclusion criteria not 
met, failure of subject to maintain adequate study compliance)  
 
The following information is required to be collected at study exit: 
• Date of Study Exit 
• Reason for exit (subject status) 
o AE related 
o Covid related 
 
If discontinuation is because of safety or lack of effectiveness, the subject shall be asked to be followed 
for collecting safety data outside the clinical investigation. 
9.17.2 
Study Completed 
At the completion of the 30-day follow-up visit, subjects will be exited from the study. The 30-day 
follow-up visit and exit visit should be combined, and both a 30-day Subject Visit CRF and a Study Exit 
eCRF need to be completed.  
9.17.3 
Lost to Follow-up 
A subject is considered to be lost to follow-up if at least two attempts to contact the subject are 
unsuccessful. The method of attempt (e.g., one letter and one phone record, or two letters) must be 
documented in the subject’s medical record. In addition, regulation set forth by the governing IRB/REB 
must be followed.  
9.17.4 
Subject Chooses to Exit (i.e. Revokes Consent) 
A subject can withdraw from the study at any time. If the subject wishes to exit from the study (i.e. the 
subject revokes consent), the study site is required to document the reason for exit on the Study Exit 
CRF. In addition, study sites shall follow the regulations set forth by the governing IRB/RCB. If possible, 
the following data should be collected prior to subject withdrawal: 
• 
Date of study exit 
• 
Reason for exit 
9.17.5 
Investigator Withdraws Subject 
No subjects should be withdrawn by investigators unless compelling medical justification is present. It is 
recommended investigators discuss any withdrawals with the study team prior to withdrawing subjects. 

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Early removal of Novapak (within the first 7 days of application) alone may not be a reason for subject 
withdrawal. If an Investigator Withdrawal is necessary, the following data should be collected prior to 
subject withdrawal if possible: 
• 
Date of study exit 
• 
Reason for subject withdrawal 
10. Risks and Benefits 
10.1 Potential Risks 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of a product, 
from the business analysis phase through development, market release, and post-market surveillance. 
The risk analysis process for the Novapak Study, is being performed in accordance with ISO 14971 and 
will ensure that the level of risk is acceptable prior to starting the study.  
There are no incremental risks introduced to the subject as a result of participation in this study. 
There are inherent risks for nasal sinus surgery as well as any surgery where removal, cutting and 
modification of tissues are required.  These risks include: 
• 
Mild Bleeding 
• 
Adhesions, tissue synechia 
• 
Fatigue 
• 
Infection 
• 
Moderate Pain 
• 
Inflammation and swelling 
• 
Nasal Congestion 
• 
Mild to moderate headaches 
• 
Facial pressure 
 
Nasal sinus packing in general has tried to address these surgical complications but may result in risks 
that are specific to the use of packing, as follows: 
• 
Bleeding – present if packing is inadequate or bleeding is excessive– may require post-operative 
controls (e.g., suturing, cautery, more packing)  
• 
Adhesions – present if packing is inadequate to separate tissue compromised due to surgical 
trauma – requires post-operative debridement of tissues which may lead to bleeding. 
• 
Scarring - This risk is where the tissue heals abnormally  

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• 
Infection – due to introduction of bacterial during the surgery and/or if sterility is breached - 
packing could encourage bacterial growth if design controls are not in place to control bacterial 
growth. 
• 
Toxic Shock Syndrome –defined as “A severe illness caused by infection with staphylococcus 
aureus and characterized by high fever of sudden onset, vomiting, diarrhea, and myalgia, 
followed by hypotension and in severe cases, shock; a sunburn like rash with peeling of the skin, 
especially of the palms and soles, occurs during the acute phase.” 
• 
Respiratory Obstruction – physical obstruction of the breathing pathway – This harm may occur 
from stent migration and cause difficulty breathing (i.e., hypoxia, dyspnea) 
• 
Aspiration of the packing – causes respiratory obstruction with tachypnea can lead to aspiration 
pneumonia, urgent medical intervention may be necessary 
• 
Pneumonia - If the stent were aspirated, pneumonia may occur. The patient may be treated 
with IV medication. 
• 
Potential toxicity reactions – components of the packing could lead to a toxicity reaction due to 
a non-biocompatibility reaction occurring, but the reaction would not be expected to go beyond 
an inflammatory response. (i.e., redness, swelling, etc.) 
• 
Potential allergic hypersensitivity reactions – components of the packing could lead to an 
allergic hypersensitivity reaction - A patient may experience edema and difficulty breathing with 
IV medications used as medical intervention. 
• 
Foreign Body Reaction - Potential tissue interactions with packing components, fragments, or 
surface texture. In addition to an inflammatory response, it usually includes the formation of a 
foreign body granuloma, or encapsulation around a foreign object. Medical intervention may be 
taken to remove the product. 
• 
Inflammation - This harm includes local irritation from the product. This risk may require Oral 
medication to reduce inflammatory response. 
• 
Fever - A medium-low grade fever may develop. This risk may require Oral medication to reduce 
inflammatory response. 
• 
Device Fragments in Patient – If a device fragments migration of pieces of the stent could result 
in possible medical intervention needed 
• 
Pain – during post-operative removal of non-dissolving packing devices most patients have 
reported some mild temporary pain. 
• 
Decreased Therapeutic Response – The packing may not perform as expected and not control 
the risks as intended.  It would not result in surgical correction but may require a minor medical 
intervention. 
 
The use of the Novapak Nasal Sinus Packing and Stent may involve the risks listed above for all packing 
type devices, with the exception of pain upon removal, since it dissolves away with irrigation. There may 
be other discomforts and risks related to the Novapak Nasal Sinus Packing and Stent device and/or this 
study that are not foreseen at this time. 

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These are the current risks of Novapak seen in the field based on reports to our complaint system: 
(number of reported events as of June 24, 2022) 
• 
Irritation – potential shellfish hypersensitivity (1) 
• 
Post-operative bleeding requiring secondary controls (3) 
• 
Post-operative device migration to oral cavity (1) 
• 
Post-operative edema and pain (2) 
10.2 Risk Minimization 
The potential risks associated with the Novapak device were identified and have been successfully 
mitigated. Any potential risks associated with this study are further minimized by selecting qualified 
investigators and training study personnel on the CIP.  
In addition, investigators will be actively involved in the nasal sinus surgery and follow-up of the subjects 
using the Novapak device.  
Risks will be minimized by careful assessment of each subject prior to, during and after surgery, and 
during and after application of the Novapak Nasal Sinus Packing and Stent device. Prior to surgery, each 
subject will be screened for shellfish allergy to mitigate the risk of a hypersensitivity reaction to the 
chitosan component of the device. It is recommended subjects undergo a complete physical evaluation. 
Medtronic has further minimized the possibility of risks by: performing required laboratory and pre-
clinical testing prior to the Novapak study, implementing quality control measures into production 
processes, providing guidelines for subject selection and evaluation, and providing adequate instructions 
and labeling.  
After surgery, subjects in the Novapak Study will be followed at regular intervals to monitor the 
condition of the nasal sinus healing process. At each protocol required follow-up, the investigator must 
assess any adverse events. 
Table 7: Potential risks and risk minimization 
Potential risk  
Risk Minimization 
Hypersensitivity 
Screening for shellfish allergy  
Infection 
Design controls – device component has an antimicrobial effect 
10.3 Potential Benefits 
The Novapak Device is used for nasal packing to prevent bleeding after sinus surgery and may offer no 
benefit. The potential benefits of having the Novapak Nasal Sinus Packing and Stent device include 
control of minimal bleeding, prevent post-surgical adhesions by acting as a space occupying stent which 
separates tissues compromised by surgical trauma, aid in the natural healing process, eliminate the 
need for packing removal by dissolving away with irrigation. These potential benefits aid the patient as 
well as the physician by providing a tool to manage common post-surgical effects (i.e. bleeding, 

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adhesions and removal of packing). Additionally, information collected from this study may assist in the 
design of new products/therapies and/or IFU. 
10.4 Risk-Benefit Rationale 
The use of the Novapak device does not appear to add unreasonable risks to the common technique of 
nasal packing post nasal sinus surgery. Benefits of nasal packing with the Novapak device (Section 10.3) 
when used by a trained physician greatly outweigh any risks associated with this therapy (Section 10.1). 
10.5 Risk Determination 
The Novapak device is commercially available in the US and Canada. The device was cleared for use 
under US FDA 510(k) number K202623 on December 08, 2020, and this study is therefore exempt per US 
FDA 21 CFR 812.  The device is licensed for use in Canada under license number 103651 issued 
September 25, 2019. 
11. Adverse Events and Device Deficiencies 
This section describes how Adverse Events and Device Deficiencies will be handled in this study. 
11.1 Adverse Events 
AE definitions are provided in Table 9. All AE information will be collected throughout the study 
duration, starting during sinus surgical procedure and treatment with the Novapak device and 
concluding with the 30-day visit and/or study exit (whichever occurs first).  
Reporting of these events to Medtronic will occur on an AE eCRF. Each event must be reported 
separately. Documented pre-existing conditions are not considered AEs unless the nature or severity of 
the condition has worsened.  
In all geographies, UAEs occurring post-surgery need not be reported unless the adverse event worsens 
or is present outside the stated timeframe post-surgery.  
Table 8: Post-Surgery Unavoidable Adverse Events 
Event Description 
Timeframe – days after 
surgical procedure 
Sudden visual changes or ocular swelling 
1 
Fever higher than 101°F 
1 
Anesthesia related complications 
2 
Medication related complications 
2 
Mild bleeding (bloody discharge) 
5 
Constant clear watery discharge 
7 
Facial pressure 
7 
Fatigue  
7 
Inflammation and swelling 
7 

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Mild to moderate headaches  
7 
Moderate pain  
7 
Numbness of the Teeth or Palate 
7 
Nasal congestion  
10 
 
For AEs that require immediate reporting (see Table 11), initial reporting may be done by email or 
phone, or on the eCRF completing as much information as possible. The completed AE eCRF must be 
submitted to Medtronic as soon as possible.   
Any medication/treatment associated with the treatment of an AE must be reported.  
Subject deaths are also required to be reported. Refer to Section 11.6 for Subject Death collection and 
reporting requirements. 
11.2 Device Deficiency 
The DD definition is provided in Table 9. DD information will be collected throughout the study and 
reported to Medtronic. Note that DD that result in an AE to the subject should be captured as an AE 
only. 
DD that did not lead to an AE but could have led to a SADE (i.e., if suitable action had not been taken, if 
intervention had not been made, or if the circumstances had been less fortunate) require immediate 
reporting (see Table 11). 
11.3 Processing Updates and Resolution 
For any changes in status of a previously reported adverse event or DD (i.e. change in actions taken, 
change in outcome, change in relatedness), information needs to be updated on, or added to the 
original AE or DD eCRF. All AEs must be followed until the AE has been resolved, is unresolved with no 
further actions planned, the subject dies or exits the study, or until study closure, whichever occurs first.  
At the time of study completion, all collected adverse events that are unresolved must be reviewed and 
an update to the original AE must be reported. 
11.4 Definitions/Classifications 
Where the definition indicates “device”, it refers to only the device under investigation used in the 
study.  
Table 9: Adverse Event and Device Deficiency Definitions 
General 
Adverse Event 
An untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs in subjects, users or other 

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persons, whether or not related to the investigational medical 
device and whether anticipated or unanticipated. 
NOTE: This definition includes events related to the 
investigational medical device. 
NOTE: This definition includes events related to the 
procedures involved. 
NOTE: for users or other persons, this definition is restricted to 
events related to the use of investigational medical devices. 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical 
device. 
NOTE: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation or any malfunction of 
the investigational medical device. 
NOTE: This definition includes any event resulting from use 
error or from intentional misuse of the investigational medical 
device. 
Device Deficiency 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety or performance. 
NOTE: Device deficiencies include malfunctions, use errors, 
and inadequacy in the information supplied by the 
manufacturer including labeling. 
Relatedness - Procedure 
An event that occurs as a result of the nasal sinus surgical 
procedure(s). This includes events involving devices used in the 
surgical procedure that are not the study device being 
assessed. 
Relatedness - Device 
An event that occurs as a result of application or use of the 
study device being assessed. 
Relationship – Not Related 
The relationship to the device or procedures can be excluded 
when: 

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• 
the event is not a known complication or side effect of 
the procedures, study device or product category the 
device belongs to or of similar devices  
• 
the event has no temporal relationship with the use of 
the study device or the procedures 
• 
the event does not follow a known response pattern to 
the study device (if the response pattern is previously 
known) and is biologically implausible 
• 
the discontinuation of study 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 event 
• 
the event involves a body-site, or an organ not 
expected to be affected by the device or procedure 
• 
the event can be attributed to another cause (e.g. an 
underlying or concurrent illness/ clinical condition, an 
effect of another device, drug, treatment or other risk 
factors) 
• 
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 seriousness of the event. 
Relationship - Possible 
The relationship with the procedure or use of the study 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. 
Relationship - Probable 
The relationship with the procedure or use of the study device 
seems relevant and/or the event cannot reasonably be 
explained by another cause, but additional information may be 
obtained. 

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Relationship - Causal 
The event is associated with the study device or with 
procedures beyond reasonable doubt when:  
• 
the event is a known complication or side effect of the 
procedure, study device, or product category the device 
belongs to or of similar devices  
• 
the event has a temporal relationship with the study 
device use/application or procedures 
• 
the event involves a body-site or organ that  
o the study device or procedures are applied to 
o the study device or procedures have an effect on 
• 
the event follows a known response pattern to the study 
device (if the response pattern is previously known) 
• 
the discontinuation of the study device application (or 
reduction of the level of activation/exposure) and 
reintroduction of its use (or increase of the level of 
activation/exposure), impact on the event (when clinically 
feasible) 
• 
other possible causes (e.g. an underlying or concurrent 
illness/ clinical condition or/and an effect of another 
device, drug or treatment) have been adequately ruled out 
• 
harm to the subject is due to error in use 
In order to establish the causal relationship, not all the criteria 
listed above might be met at the same time, depending on the 
type of device/procedures and the seriousness of the event.  
Serious Adverse Event (SAE) 
Adverse event that led to any of the following: 
a) Death, 
b) Serious deterioration in the health of the subject, 
users, or other persons as defined by one or more of 
the following: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a 
body function including chronic diseases, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-
threatening illness or injury or permanent 

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impairment to a body structure or a body function,
 
 
c) Fetal distress, fetal death, a congenital abnormality, or 
birth defect including physical or mental impairment.  
NOTE: Planned hospitalization for a pre-existing condition, or a 
procedure required by the CIP, without serious deterioration in 
health, is not considered a serious adverse event. 
Serious Adverse Device Effect 
(SADE) 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Serious Health Threat 
A signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration 
in the health in subjects, users or other persons, and that 
requires prompt remedial action for other subjects, users or 
other persons 
 
NOTE: This would include events that are of significant and 
unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple deaths 
occurring at short intervals. 
Unavoidable Adverse Event (UAE) An adverse event that is an expected, known complication or 
side effect occurring after a surgical procedure.  
11.5 Reporting of Adverse Events 
11.5.1 
Adverse Event and Device Deficiency Classification 
All AE and DD will be reviewed by a Medtronic representative. AEs will be classified according to the 
definitions provided.  
Upon receipt of AE at Medtronic, a Medtronic representative will review the AE/DD for completeness 
and accuracy and when necessary, will request clarification and/or additional information from the 
Investigator. Medtronic will utilize Medical Dictionary for Regulatory Activities (MedDRA), to assign a 
MedDRA term for each AE based on the information provided by the investigator.  
Regulatory reporting of AEs and DDs will be completed according to local regulatory requirements. Refer 
to Table 11 for a list of required investigator and Medtronic reporting requirements and timeframes. It 
is the responsibility of both to abide by any additional AE reporting requirements stipulated by the 
IRB/REB responsible for oversight of the study. 

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Appendix A contains the FAL, which is a list of AEs related to the device or procedure that have been 
observed in previous studies and may be experienced by subjects. This list may help to assess if an AE is 
unanticipated in nature.   
For emergency contact regarding a SAE and/or SADE, contact a study representative immediately (refer 
to the study contact list provided in the study site’s study documents binder/investigator site file or 
refer to the Sponsor contact information provided on the title page). 
AEs will be classified according to the standard definitions as outlined below: 
Table 10: Adverse Event Classification Responsibilities 
What is classified?  
Who classifies? 
Classification Parameters 
Relatedness 
Investigator 
Device and/or Procedure. 
• 
Relationship: not related, possible, probable, causal 
Sponsor 
Device and/or Procedure. 
• 
Relationship: not related, possible, probable, causal 
Seriousness 
Investigator 
SAE, DD with SADE potential 
Sponsor 
SAE, DD with SADE potential  
Diagnosis 
Investigator 
Based on presenting signs and symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based on the data provided by 
Investigator 
 
11.5.2 
Adverse Event and Device Deficiency Reporting Requirements 
Regulatory reporting of AEs and DDs will be recorded and reported according to local regulatory 
requirements. It is the responsibility of the Investigator and the sponsor to abide by the AE reporting 
requirements stipulated by local law and the study site’s IRB/REB. 
Sponsor shall fully record all of the following: (a) any adverse event of a type identified in the CIP as 
being critical to the evaluation of the results of that clinical investigation, (b) any serious adverse event, 
(c) any device deficiency that might have led to a serious adverse event if appropriate action had not 
been taken, intervention had not occurred, or circumstances had been less fortunate, (d) any new 
findings related to any event referred to in previous points and (e) any additional CIP procedure 
relatedness. 
All reporting shall include the date of the adverse event, treatment, resolution, assessment of 
seriousness and the relationship to the investigational device and the related procedure. 

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Table 11: AE and DD Reporting Requirements 
SAEs 
Investigator shall submit to: 
Medtronic 
All geographies: Report to the sponsor, without unjustified delay, all serious adverse 
events. 
RA 
All geographies: Submit to RA per local reporting requirement. 
IRB/REB 
All geographies:  Submit to IRB/REB per local reporting requirement. 
Sponsor shall submit to: 
RA 
All geographies: Submit to RA per local reporting requirement. 
IRB/REB 
All geographies: Submit to IRB/REB per local reporting requirement. 
ADEs 
Investigator shall submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the 
effect. 
RA 
All geographies: Submit to RA per local reporting requirement. 
IRB/REB 
All geographies: Submit to IRB/REB per local reporting requirement. 
Sponsor shall submit to: 
RA 
All geographies: Submit to RA per local reporting requirement. 
IRB/REB 
All geographies: Submit to IRB/REB per local reporting requirement. 
SADEs  
Investigator shall submit to: 
Medtronic 
All geographies:  Immediately after the investigator learns of the event or of new 
information in relation to an already reported event. 
RA 
All geographies: Submit to RA per local reporting requirement 
IRB/REB 
All geographies: Submit to IRB/REB per local reporting requirement. 
Sponsor shall submit to: 
RA 
 
All geographies: Submit to RA per local reporting requirement. 
IRB/REB 
All geographies:  Submit to IRB/REB per local reporting requirement. 
Investigators All geographies: Submit per local reporting requirement. 
All other reportable AEs  
Investigator shall submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the 
event. 
RA 
All geographies: Submit to RA per local reporting requirement. 
IRB/REB 
All geographies: Submit to IRB/REB per local reporting requirement. 

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DDs with SADE potential 
Investigator shall submit to: 
Medtronic 
All other geographies: Submit or report as required per local reporting requirements. 
RA 
All geographies: Submit to RA per local reporting requirement. 
IRB/REB 
All geographies: Submit to IRB/REB per local reporting requirement. 
Sponsor shall submit to: 
RA 
All geographies: Submit to RA per local reporting requirement. 
IRB/REB 
All geographies: Submit to IRB/REB per local reporting requirement. 
All other Device Deficiencies 
Investigator shall submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the 
deficiency. 
RA 
All geographies: Submit to RA per local reporting requirement. 
IRB/REB 
All geographies: Submit to IRB/REB per local reporting requirement. 
 
11.6 Subject Death 
All subject deaths must be reported by the investigator to Medtronic on a single AE form (AE with 
outcome of fatal) as soon as possible after the investigator first learns of the death.   
A copy of the death certificate, if available and allowed by state/local law, should be sent to the 
Medtronic clinical study team. When a death occurs in a hospital, a copy of the death summary report 
and all relevant hospital records, if available should be sent to the Medtronic clinical study team. If an 
autopsy is conducted, a copy of the autopsy report should also be sent to the Medtronic clinical study 
team if available and allowed by state/local law. When the death occurs at a remote study site, it is the 
investigative study site’s responsibility to attempt retrieval of information about the death. Additionally, 
device disposition information should be updated.  
In summary, the following data will be collected: 
• 
Date of death 
• 
Detailed description of death 
• 
Cause of death  
• 
Relatedness to device and/or procedure 
• 
Device disposition information 
• 
Death summary/hospital records (if available and allowed by state/local law) 
• 
Autopsy report (if available and allowed by state/local law) 
• 
Death certificate (if available and allowed by state/local law) 

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11.6.1 
Death Classification and Reporting 
Sufficient information will be required in order to properly classify the subject’s death. The Medtronic 
Representative will review any reported deaths in the study subjects and obtain documentation 
regarding the primary cause of death and classification of death. Regulatory reporting of Subject Deaths 
will be completed according to local regulatory requirements. 
11.7 Product Complaint Reporting 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless whether they are related to intended use, misuse or abuse 
of the product. Reporting must be done immediately and via the regular channels for market-released 
products. The reporting of product complaints by the clinical team must be done according to the local 
Standard Operating Procedures. Medtronic will notify the RAs (e.g. CA) as applicable for the following 
incidents immediately upon learning of them and is not limited to AEs and DDs only: 
• 
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as 
any inadequacy in the labeling or instructions for use which led or might have led to the death or 
serious deterioration in the state of health of a patient, user, or other person. 
• 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
 
12. Data Review Committees 
 
12.1 Clinical Events Committee Review 
CEC is not needed for this study.  This decision was made based on the following criteria: fast enrollment 
in this trial makes a CEC impractical, and there are no additional benefits of a CEC reviewing the data.  
12.2 Data Monitoring Committee  
DMC is not needed for this study.  This decision was made based on the following criteria: fast 
enrollment in this trial makes a DMC impractical, and there are no additional benefits of a DMC 
reviewing the data. 
13. Statistical Design and Methods 
The following section describes the statistical design and methods for the Novapak study in general.  
13.1 General Aspects of Analysis 
Novapak Nasal Sinus Packing and Stent Study is a prospective, non-randomized, non-blinded, multi-site, 
investigational, clinical study. 

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The statistical analyses will be performed by Medtronic employed statisticians. The study population is 
defined as all eligible patients who signed the Patient Informed Consent Form.  
All data collected from enrolled subjects will be utilized in the analyses as appropriate. Analyses of the 
primary and secondary endpoints will be descriptive. 
All continuous variables will be summarized as the number of subjects, means, standard deviations, 
medians, minimums, maximums, and interquartile ranges. Categorical variables will be summarized as 
frequencies and percentages.  
Any deviations from the original statistical plan will be summarized in the Clinical Study Report(s) (CSRs), 
along with the justification for the deviations. 
No statistical techniques will be used to impute missing data for continuous or categorical outcomes. If a 
subject’s data are missing for any reason, that subject will not be included in that portion of the analysis. 
The number of subjects included in each analysis will be reported so that the reader can assess the 
potential impact of missing data. 
13.2 Interim Analysis 
No interim analyses are planned for this study. 
13.3 Primary Objective(s) 
The primary objective is to assess the safety of the Novapak Sinus Packing and Stent device for use in 
patients undergoing nasal/sinus surgery: 
• 
Collect all AEs directly attributed to the device and/or those that cannot be determined 
• 
Collect all AEs and establish an overall rate and safety profile for the device 
13.4 Secondary Objective(s) 
The secondary objectives are to confirm device effectiveness during the procedure, 2 weeks and 1-
month post treatment. 
13.5 Sample Size Determination 
As this is not a powered hypothesis-driven study, the sample size of a minimum of 75 subjects was 
selected that is adequate to assess the safety and treatment effectiveness of the Medtronic Novapak 
Nasal Sinus Packing and Stent device, not determined by statistical methods.  
13.6 Minimization of Bias 
The study methods include the following measures to minimize potential sources of bias: 
• 
A qualified member of the investigational site’s research team will review the inclusion and 
exclusion criteria to screen each subject to confirm subject eligibility. 
• 
All sites will follow a standardized protocol for acquisition of endpoint data. 

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14. Ethics 
14.1 Statement(s) of Compliance 
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as GCP. GCP includes review and approval by an independent IRB/REB before initiating a study, 
continuing review of an ongoing study by an IRB/REB, and obtaining and documenting the freely given 
informed consent of a subject before initiating the study. 
The Novapak Study was designed to reflect the GCP principles outlined in ISO 14155:2020 and other 
international clinical requirements outlined below. These include the protection of the rights, safety and 
well-being of human subjects, controls to ensure the scientific conduct and credibility of the clinical 
investigation and the definition of responsibilities of the sponsor and investigators. In accordance with 
ISO 14155:2020, the sponsor shall avoid improper influence on, or inducement of, the subject, monitor, 
any investigator(s) or other parties participating in, or contributing to, the clinical investigation. All 
investigators shall avoid improper influence on or inducement of the subject, sponsor, monitor, other 
investigator(s) or other parties participating in or contributing to the clinical investigation. AE and DD 
handling in the Novapak Study is ISO 14155:2020 compliant for all participating geographies.  
The principles of the Declaration of Helsinki (DoH) have been implemented through the IC process, 
IRB/REB approval, study training, clinical trial registration, pre-clinical testing, risk-benefit assessment 
and publication policy.  
Ultimately, all study sites in all geographies will follow and comply with: 
• 
Principles of DoH 
• 
21 CFR Part 11 (Electronic Records, Electronic Signatures) 
• 
21 CFR Part 54 (Financial Disclosure by Clinical Investigators) 
• 
The CTA 
• 
The procedures described within this CIP 
• 
Local IRB/REB Requirements 
 
In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national and local laws, regulations, standards, and requirements of the countries/geographies 
where the study is being conducted. These include but are not limited to:  
• 
In the United States, the study will be conducted in compliance with 21 CFR Parts: 
▪ 
50: Protection of Human Subjects 
▪ 
54: Financial Disclosure by Clinical Investigators 
▪ 
56: IRBs 
▪ 
803: Complaint reporting 
• 
In Canada, in compliance with Canada Medical Device Regulation 1998 SOR/98-292 

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The study will be publicly registered prior to subject enrollment in accordance with the 2007 FDAAA and 
DoH on http://clinicaltrials.gov (PL 110-85, section 810(a)). In addition, the study may be registered in 
local regulatory databases where required by local law.  
Approval of the CIP and CIP amendments is required from the following groups prior to any study 
procedures at a study site: 
• 
Medtronic 
• 
Principal Investigators (where required by local law/regulations) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent medical IRB/REB 
 
15. Study Administration 
15.1 Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of this study.  Trained Medtronic 
personnel or delegates appointed by Medtronic may perform study monitoring at the study site, or 
remotely in order to ensure that the study is conducted in accordance with the CIP, the CTA, and the 
applicable regulatory and local requirements. Medtronic, or delegates, must therefore be allowed direct 
access to the subjects’ case histories (clinic and hospital records, and other source data/documentation) 
upon request as per the IC, Research Authorization (where applicable) and CTA.  The principal 
investigator should also be available during monitoring visits.   
Monitoring visits may be conducted at the start, during and at the closure of the clinical study in 
accordance with Medtronic SOPs and the Monitoring Plan. At minimum, it will be verified whether 
signed and dated ICFs have been obtained from each participant at the point of enrollment and that AEs 
discussed in Section 11 were reported via completion of the AE eCRFs.  
15.2 Data Management 
Data will be collected using an electronic data management system for studies.  CRF data will be stored 
in a secure, password-protected database hosted in a cloud service which is owned and validated by a 
third party.  Data will be reviewed using programmed and manual data checks.  Data queries will be 
made available to study sites for resolution.  Study management reports may be generated to monitor 
data quality and study progress.  At the end of the study, the data will be frozen and will be retained by 
Medtronic in accordance with applicable regulations. 
All records and other information about subjects participating in this study will be treated as 
confidential. Data will be transferred and processed by Medtronic or a third party designated by 

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Medtronic in a key coded form, unless it’s impossible to pseudonymize for instance, where the subject’s 
name cannot be removed from the data carrier. 
Procedures in the CIP require source documentation. Source documentation will be maintained at the 
study site. Source documents, which may include worksheets, subject medical records, and laboratory 
reports, must be created and maintained by the investigational study site team.  
The investigator will clearly mark clinical records to indicate that the subject is enrolled in this clinical 
investigation.  
The data reported on the CRFs shall be derived from source documents and be consistent with these 
source documents, and any discrepancies shall be explained in writing. Refer to the Case Report Form 
Instructions for CRFs and data collection elements that may be considered source. 
15.3 Direct Access to Source Data/Documents 
Medtronic may conduct audits at participating study sites. The purpose of an audit is to verify the 
performance of the monitoring process and the study conduct, independently of the personnel directly 
involved in the study. RAs, such as the FDA, may also perform inspections at participating study sites. 
The investigator and/or institution shall permit Medtronic, IRB/REBs and RAs direct access to source 
data and documents during monitoring, audits and regulatory inspections. 
15.4 Confidentiality 
All information and data sent to parties involved in study conduct concerning subjects or their 
participation in this study will be considered confidential. Study sites will assign a unique SID to each 
subject. Records of the subject/SID relationship will be maintained by the study site. The SID number is 
to be recorded on all study documents to link them to the subject’s medical records at the study site.  
Confidentiality of data will be observed by all parties involved at all times throughout the clinical 
investigation. All data shall be secured against unauthorized access. The privacy of each subject and 
confidentiality of his/her information shall be preserved in reports and when publishing any data.  In the 
US, “Protected Health Information” (PHI) will be maintained in compliance with the HIPAA of 1996. To 
maintain confidentiality, the subject’s name or any other PHI should not be recorded on any study 
document other than the IC. This scenario will be covered in the IC. In the event a subject’s name/PHI is 
included for any reason, it will be blinded as applicable. In the event of inability to blind the 
identification (e.g., digital media), it will be handled in a confidential manner by the authorized 
personnel.  Data relating to the study might be made available to third parties (for example in case of an 
audit performed by RA), provided the data are treated as confidential and that the subject’s privacy is 
guaranteed. No identifiable subject information will be published. 

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15.5 Clinical Trial Agreement 
Medtronic contracts with participating institutions/investigators through a Clinical Trial Agreement that 
defines the scope and responsibilities and associated compensation related to carrying out the 
obligations under a clinical study sponsored by Medtronic. 
Investigators that have a vested financial interest in Medtronic or the commercial sales and use of the 
study device will not be eligible for participation in this clinical trial. Medtronic will control this potential 
bias through the investigator / site selection process. 
15.6 Liability/Warranty/Insurance Information 
15.6.1 
Warranty 
Warranty information is provided in the product packaging for the commercially released device and 
additional copies are available upon request.  
15.6.2 
Insurance (Canada) 
Medtronic of Canada ULC is a wholly owned subsidiary of Medtronic, which as the parent company of 
such entity maintains appropriate general liability insurance coverage as required under applicable laws 
and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a General Liability insurance statement/certificate will be provided to the REB. 
15.6.3 
Insurance (US) 
Medtronic Xomed Ltd. is a wholly owned subsidiary of Medtronic, which as the parent company of such 
entity maintains appropriate clinical trial liability insurance coverage as required under applicable laws 
and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a Clinical Trial insurance statement/certificate will be provided to the IRB. 
15.6.4 
Subject Compensation 
Reasonable provisions for subject time and effort will be compensated where required and/or approved 
by the governing IRB/REB. The amounts and events/tasks compensated will be detailed in the site-
specific Clinical Trial Agreement. 
 
15.7 CIP Amendments 
Any revisions or amendments to the CIP or IC document, along with a statement of justification for the 
changes, will be submitted to all investigational sites and governing IRB/REBs, according to applicable 
regulations. Approval by IRB/REBs (where applicable) must be obtained prior to implementing a CIP 
revision at the study site. 
15.8 Record Retention 
All study-related documents must be retained for a period of at least 2 years after study closure (or 
longer if required by local law). Medtronic will inform the investigator/study site when these documents 
are no longer required to be retained. 

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No study document or image will be destroyed without prior written agreement between Medtronic 
and the investigator. The investigator should take measures to prevent accidental or premature 
destruction of documents. Should the investigator wish to assign the study records to another party or 
move them to another location, advance written notice must be given to Medtronic. 
Medtronic will retain the study records according to Medtronic corporate policy and record retention 
schedule. 
15.8.1 
Investigator Records 
The investigator is responsible for the preparation and retention of the records cited below. All of the 
below records, with the exception of case history records and case report forms, should be kept in the 
Investigator Site File (i.e., the study binder provided to the investigator) or Subject Study Binder. CRFs 
must be maintained and signed electronically within the electronic data capture system during the 
study. The following records are subject to inspection and must be retained for a period of two years (or 
longer as local law or hospital administration requires) after the date on which the investigation is 
terminated. 
• 
All correspondence between the IRB/REB, sponsor, monitor, RA and the investigator that pertains to 
the investigation, including required reports.  
• 
Subject’s case history records, including:  
▪ 
Signed and dated IC (In U.S. and Canada, signed by subject).  
▪ 
Observations of AEs/ DDs 
▪ 
Medical history 
▪ 
Surgery and follow-up data  
▪ 
Documentation of the dates and rationale for any deviation from the protocol 
• 
List of investigation study sites 
• 
Subject screening information 
• 
Normal value(s)/range(s) for clinical laboratory test(s) 
• 
Lab report(s)  
• 
Device use information containing model (CFN) and serial/lot numbers, subject IDs of the subjects 
receiving device, receive date by subject.  
• 
All approved versions of the CIP, IC  
• 
Signed and dated CTA  
• 
CV of principal investigators and key members of investigation study site team (as required by 
applicable regulations. 
• 
Documentation of delegated tasks  
• 
IRB/REB approval documentation. Written information that the investigator or other study staff, 
when member of the IRB/REB, did not participate in the approval process. Approval documentation 
must include the IRB/REBs composition, where required per local law.   
• 
Study training records for study site staff.  

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• 
Any other records that local regulatory agencies require to be maintained  
• 
Final Study Report including the statistical analysis 
15.8.2 
Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records: 
• 
All correspondence which pertains to the investigation 
• 
Signed Investigator Agreements, Financial Disclosure (if applicable) and current CV of principal 
investigator and key members of the investigation study site team (as required by local law), 
delegated task list 
• 
All signed and dated case report forms submitted by investigator, including reports of AEs, and DDs  
• 
All approved IC templates, and other information provided to the subjects and advertisements, 
including translations 
• 
Copies of all IRB/REB approval letters and relevant IRB/REB correspondence and IRB/REB voting 
list/roster/letter of assurance 
• 
Names of the institutions in which the study will be conducted 
• 
Names/contact addresses of monitors 
• 
Monitoring visit reports 
• 
Statistical analyses and underlying supporting data 
• 
Final report of the study 
• 
The CIP, and study related reports, and revisions 
• 
Study training records for study site personnel and Medtronic personnel involved in the study 
• 
Any other records that local regulatory agencies require to be maintained.  
 
Medtronic records and reports will be maintained in a password-protected document management 
system, and paper documents (where applicable) will be stored in stored in secured file cabinets at 
Medtronic during the course of this study.  
After closure of the study Medtronic will archive records and reports indefinitely. 
15.9 Reporting Requirements 
15.9.1 
Investigator Reports 
The investigator is responsible for the preparation (review and signature) and submission to the sponsor 
of all case report forms, adverse events and device deficiencies, deaths, and any deviations from the 
clinical investigation plan.  If any action is taken by an IRB/REB with respect to this study, copies of all 
pertinent documentation must be forwarded to Medtronic in a timely manner. Reports are subject to 
inspection and to the retention requirements as described above for investigator records.  
Safety data investigator reporting requirements are listed in Section 11. The investigator shall prepare 
and submit in a complete, accurate and timely manner the reports listed in this section. 

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Table 12: Investigator Reports Applicable for All Geographies per Medtronic Requirements 
Report  
Submit to 
Description/Constraints 
Withdrawal of 
IRB/REB approval 
Sponsor and 
Relevant 
Authorities 
The investigator must report a withdrawal of approval by the 
reviewing IRB/REB of the investigator’s part of the 
investigation within 5 working days. 
Study Deviations  
Sponsor and 
IRB/REB 
Any deviation from the clinical investigational plan shall be 
recorded together with the explanation of the deviation. 
Notice of deviations from the CIP to protect the life or 
physical well-being of a subject in an emergency shall be 
given as soon as possible, but no later than 5 working days 
after the emergency occurred.  Except in such emergency, 
prior approval is required for changes in the plan or 
deviations.  
Final Report 
IRBs/REBs and  
Relevant 
Authorities 
This report must be submitted within 3 months of study 
completion or termination. 
 

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Table 13: Additional Investigator reports applicable to the United States per FDA regulations 
Report  
Submit to 
Description/Constraints 
Withdrawal of IRB 
approval (either 
suspension or 
termination) 
Sponsor 
The investigator must report a withdrawal of approval by the 
reviewing IRB of the investigator’s part of the investigation 
within 5 working days.  (21 CFR 812.150(a)(2)) 
Study deviations  
Sponsor and 
IRB 
Notice of deviations from the CIP to protect the life or 
physical wellbeing of a subject in an emergency shall be given 
as soon as possible, but no later than 5 working days after 
the emergency occurred.  Except in such emergency, prior 
approval is required for changes in the plan or deviations.  If 
the deviation may affect the scientific soundness of the plan 
or the rights, safety and welfare of the subjects, the deviation 
must be approved by Medtronic, the IRB, and the 
FDA/applicable RA.  If the deviation does not affect these 
issues then only Medtronic must approve it.  (21 CFR 
812.150(a)(4)) 
Failure to obtain IC 
prior to 
investigational device 
use 
Sponsor and 
IRBs 
If an investigator uses a device without obtaining IC, the 
investigator shall report such use within 5 working days after 
device use.  (21 CFR 812.150(a)(5)) 
Progress report  
Sponsor and 
IRB 
The investigator must submit this report to the sponsor and 
IRB at regular intervals, but in no event less than yearly 
intervals. (21 CFR 812.150 (a)(3)).   
Final report 
Sponsor 
IRBs 
Relevant 
Authorities 
This report must be submitted within 3 months of study 
completion or termination of the investigation or completion 
or termination of the investigator’s part of the investigation.  
(21 CFR 812.150(a)(6)) 
Other 
IRB and FDA 
An investigator shall, upon request by a reviewing IRB, FDA 
or any other RA, provide accurate, complete, and current 
information about any aspect of the investigation. (21 CFR 
812.150(a)(7)) 
 
 
 

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15.9.2 
Sponsor Reports 
Medtronic shall prepare and submit the following complete, accurate, and timely reports listed in the 
tables below (by geography).  In addition to the reports listed below, Medtronic shall, upon request of 
the reviewing IRB/REB, provide accurate, complete and current information about any aspect of the 
investigation. Medtronic reporting requirements for safety data are listed in Section 11.5. 
Table 14: Sponsor reports for Canada 
Report  
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, REB, 
Relevant 
authorities, and  
Head of the 
Institution 
Provide prompt notification of termination or suspension and 
reason(s).  
Recall and device 
disposition 
Investigators, 
Head of 
Institution, 
REB, 
relevant 
authorities, and  
FDA 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, or 
otherwise dispose of any devices.   
Study deviation  
Investigators 
Ensure that all deviations from the CIP are reviewed with the 
appropriate clinical investigator(s), are reported on the CRFs 
and the final report of the clinical investigation.  
Study site specific study deviations will be submitted to 
investigators periodically.   
 
Table 15: Sponsor reports for the United States 
Report  
Submit to 
Description/Constraints 
Withdrawal of IRB 
approval 
Investigators, IRB, 
and 
relevant 
authorities 
Notification within five working days.  (21 CFR 812.150(b)(2))  

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Report  
Submit to 
Description/Constraints 
Recall and device 
disposition 
Investigators, 
Head of 
Institution, 
IRB, and 
relevant 
authorities 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, or 
otherwise dispose of any devices.  (21 CFR 812.150(b)(6)) 
Final report 
Investigators, 
IRB 
A final report will be provided to investigators, and IRBs 
within six months after completion or termination of this 
clinical study.  (21 CFR 812.150(b)(7)) 
Study deviation  
Investigators 
Ensure that all deviations from the CIP are reviewed with the 
appropriate clinical investigator(s), are reported on the CRFs 
and the final report of the clinical investigation.  
Study site specific study deviations will be submitted to 
investigators periodically.   
Other 
IRB 
Accurate, complete, and current information about any 
aspect of the investigation. (21 CFR 812.150(b)(10)) 
Premature 
termination or 
suspension of clinical 
study 
IRB, Investigators, 
and regulatory 
authorities, where 
applicable 
Medtronic will provide prompt notification of termination or 
suspension and reason(s) to investigator and where required 
to IRB and RAs. 
 
15.10 
Publication and Use of Information 
Publications from the Novapak Study will be handled according to Standard Operating Procedures and 
as indicated in the CTA. 
15.10.1 
Publication Committee 
Medtronic may form the Novapak Study Publication Committee from study investigators.  Medtronic 
personnel may serve as members of the committee.  This committee will manage study publications 
with the goal of publishing findings from the data.  The Publication Committee will develop the final 
Publication Plan as a separate document.   
The Publication Committee’s role is to: 1) manage elements addressed in the publication plan, 2) 
develop the final Publication Plan under separate cover, 3) execute the Publication Plan, 4) oversee the 
publication of primary, secondary and ancillary study results, 5) review and prioritize publication 
proposals, 6) provide input on publication content, and 7) determine authorship.  In addition, the 
committee will apply and reinforce the authorship guidelines set forth in the Publication Plan.   

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Membership in the Publication Committee does not guarantee authorship.  The committee will meet at 
regular intervals, at least yearly, as needed. 
15.10.2 
Management of Primary, Secondary, and Ancillary Publications 
The Publication Committee reviews, prioritizes, and manages all publications including primary, 
secondary and ancillary publications.  Primary and secondary publications are those that address 
analyses of any or all primary objectives or secondary objectives, respectively, as specified in the CIP.  
An ancillary publication is any publication that does not address the study objectives identified in the 
CIP.  They include publications proposed and developed by other Medtronic departments or entities, 
clinicians participating in this study, and clinicians not participating in this study.  The committee will 
work with Medtronic to ensure that requests do not present conflicts with other proposals, are not 
duplicative, and to determine which ancillary publication proposals, if any, will be supported.   
The committee may decide that no publications, including abstracts, will be published prior to the end of 
the study or with individual study site data.  Requests for publications on study objectives utilizing 
subset data (e.g., regional) will be evaluated for scientific validity and the ability of Medtronic to provide 
resources.   
15.10.3 
Criteria for Determining Authorship 
Publications will adhere to authorship criteria defined by the International Committee of Medical 
Journal Editors (ICMJE, Uniform requirements for manuscripts submitted to biomedical journals, 
www.icmje.org).  Individual authorship criteria defined by the target journal or conference will be 
followed when it differs from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all of the conditions below: 
• 
Substantial contributions to conception and design of the work, or the acquisition, analysis, or 
interpretation of data for the work; AND 
• 
Drafting the work or revising it critically for important intellectual content; AND 
• 
Final approval of the version to be published; AND 
• 
Agreement to be accountable for all aspects of the work in ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved.  
 
Decisions regarding authorship and contributor-ship will be made by the committee. The selected 
authors will be responsible for drafting the publication. All selected authors must fulfill the authorship 
conditions stated above to be listed as authors, and all contributors who fulfill the conditions must be 
listed as authors. 
All investigators not listed as co-authors will be acknowledged as the “Medtronic Novapak Study 
Investigators” and will be individually listed according to the guidelines of the applicable scientific 

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journal when possible and affiliation. Any other contributors will be acknowledged by name with their 
specific contribution indicated. 
15.10.4 
Transparency 
Transparency of clinical study results will be maintained by the following means: 
• 
A final report, describing the results of all objectives and analysis, will be distributed to all 
investigators, ECs and CAs of participating countries when required by local law 
• 
Registering and posting the study results on a publicly accessible database (e.g., ClinicalTrials.gov) 
based on the posting rules stipulated  
• 
Submitting for publication the primary study results after the study ends  
• 
Disclosing conflicts of interest (e.g., financial) of the co-authors of publications according to the 
policies set forth by the corresponding journals and conferences  
• 
Making an individual study sites study data accessible to the corresponding investigator after the 
completion of the study, if requested 
15.11 
Suspension or Early Termination 
The following sections are requirements for suspension or early termination of the whole investigation 
or one or more sites.  
15.11.1 
Planned Study Closure 
Study Closure is a process initiated by distribution of a study closure letter. Study closure is defined as 
closure of a study that occurs when Medtronic and/or regulatory requirements have been satisfied per 
the CIP and/or by a decision by Medtronic or RA), whichever occurs first. The study closure process is 
complete upon distribution of the Final Report or after final payments, whichever occurs last. Ongoing 
EC oversight is required until the overall study closure process is complete. Refer to Section 9.17 for 
additional information regarding study exit procedures. 
15.11.2 
Early Termination or Suspension 
Early Termination is the closure of a study that occurs prior to meeting defined endpoints. This is 
possible for the whole study or a single study site. Suspension is a temporary postponement of study 
activities related to enrollment and distribution of the product. This is possible for the whole study or a 
single study site.  
15.11.2.1 
Study-wide termination or suspension 
Possible reasons for considering study-wide suspension or termination of the study include but are not 
limited to: 
• 
AEs associated with the system or product under investigation which might endanger the safety or 
welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent 
• 
Decision by Medtronic or RA (where the study is operating under RA)  

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• 
Technical issues during the manufacturing process 
15.11.2.2 
Investigator/study site termination or suspension 
Possible reasons for investigator or study site termination or suspension include but are not limited to: 
• 
Failure to obtain initial IRB/REB approval or annual renewal of the study 
• 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to inclusion/exclusion 
criteria, failure to follow subjects per scheduled follow-ups)  
• 
Lack of enrollment 
• 
Noncompliance to regulations and the terms of the CTA (e.g. failure to submit data in a timely 
manner, failure to follow-up on data queries and monitoring observations in a timely manner, etc.)  
• 
IRB/REB suspension of the study site 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations)  
• 
Investigator request (e.g. no longer able to support the study) 
15.11.3 
Procedures for Termination or Suspension 
15.11.3.1 
Medtronic-initiated and regulatory authority-initiated 
• 
Medtronic will promptly inform the clinical investigators of the termination or suspension and the 
reasons and inform the RAs where required 
• 
In the case of study termination or suspension for reasons other than a temporary IRB/REB approval 
lapse, the investigator will promptly inform the IRB/REB  
• 
In the case of study termination, the investigator must inform the subjects and may inform the 
personal physician of the subjects to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subject enrollment must stop until the suspension is lifted by 
Medtronic 
• 
In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare 
15.11.3.2 
Investigator-initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the termination 
or suspension 
• 
The investigator will promptly inform the institution (where required per regulatory requirements)  
• 
The investigator will promptly inform the IRB/REB 
• 
The investigator will promptly inform the regulatory authorities 
• 
The investigator will promptly inform the subjects and/or the personal physician of the subjects to 
ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare 
15.11.3.3 
Ethics Committee-initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the termination 
or suspension within 5 business days 

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• 
Subject enrollment must stop until the suspension is lifted 
• 
Subjects already enrolled should continue to be followed in accordance with IRB/REB policy or its 
determination that an overriding safety concern or ethical issue is involved 
• 
The investigator will inform his/her institution (where required per local requirements)  
• 
The investigator will promptly inform the subjects, or legally-authorized designees or guardians 
and/or the personal physician of the subjects, with the rationale for the study termination or 
suspension 
• 
The investigator will promptly inform the RA 
16. References 
1. 
Bhattacharyya N. Incremental healthcare utilization and expenditures for allergic rhinitis in the 
United States. Laryngoscope. Sep 2011;121(9):1830-3. doi:10.1002/lary.22034 
2. 
Chung SD, Chen PY, Lin HC, Hung SH. Comorbidity profile of chronic rhinosinusitis: a population-
based study. Laryngoscope. Jul 2014;124(7):1536-41. doi:10.1002/lary.24581 
3. 
Scadding GK, Durham SR, Mirakian R, et al. BSACI guidelines for the management of 
rhinosinusitis and nasal polyposis. Clin Exp Allergy. Feb 2008;38(2):260-75. doi:10.1111/j.1365-
2222.2007.02889.x 
4. 
Weitzel EK, Wormald PJ. A scientific review of middle meatal packing/stents. Am J Rhinol. May-
Jun 2008;22(3):302-7. doi:10.2500/ajr.2008.22.3171 
5. 
Berlucchi M, Castelnuovo P, Vincenzi A, Morra B, Pasquini E. Endoscopic outcomes of resorbable 
nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized 
controlled study. Eur Arch Otorhinolaryngol. Jun 2009;266(6):839-45. doi:10.1007/s00405-008-0841-3 
6. 
Chandra RK, Kern RC. Advantages and disadvantages of topical packing in endoscopic sinus 
surgery. Curr Opin Otolaryngol Head Neck Surg. Feb 2004;12(1):21-6.  
7. 
Cowin A, D M, Wormald P. Healing of wounds created in the nasal mucosa following endoscopic 
sinus surgery can be affected by different nasal packing materials. vol 10. 2002. 
8. 
Barham HP, Sacks R, Harvey RJ. Hemostatic Materials and Devices. Otolaryngol Clin North Am. 
Jun 2016;49(3):577-84. doi:10.1016/j.otc.2016.02.002 
9. 
Dkhar LK, Bartley J, White D, Seyfoddin A. Intranasal drug delivery devices and interventions 
associated with post-operative endoscopic sinus surgery. Pharm Dev Technol. 2018/03// 
2018;23(3):282-294. doi:10.1080/10837450.2017.1389956 
10. 
Lau J, Elhassan HA, Singh N. History of intranasal splints. The Journal of Laryngology &#x0026; 
Otology. 2018;132(3):198-201. doi:10.1017/S0022215118000142 
11. 
Lee JM, Grewal A. Middle meatal spacers for the prevention of synechiae following endoscopic 
sinus surgery: a systematic review and meta-analysis of randomized controlled trials. Int Forum Allergy 
Rhinol. Nov 2012;2(6):477-86. doi:10.1002/alr.21052 
12. 
Rao SB, Sharma CP. Use of chitosan as a biomaterial: studies on its safety and hemostatic 
potential. J Biomed Mater Res. Jan 1997;34(1):21-8.  

Novapak Clinical Investigation Plan 
 
 
MDT22031 
Version A 
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13. 
Baldrick P. The safety of chitosan as a pharmaceutical excipient. Regul Toxicol Pharmacol. Apr 
2010;56(3):290-9. doi:10.1016/j.yrtph.2009.09.015 
14. 
Aziz MA, Cabral JD, Brooks HJ, et al. In vitro biocompatibility and cellular interactions of a 
chitosan/dextran-based hydrogel for postsurgical adhesion prevention. Journal of biomedical materials 
research Part B, Applied biomaterials. Feb 2015;103(2):332-41. doi:10.1002/jbm.b.33206 
15. 
Cabral JD, McConnell MA, Fitzpatrick C, et al. Characterization of the in vivo host response to a 
bi-labeled chitosan-dextran based hydrogel for postsurgical adhesion prevention. Journal of biomedical 
materials research Part A. Aug 2015;103(8):2611-20. doi:10.1002/jbm.a.35395 
16. 
Cabral JD, Roxburgh M, Shi Z, et al. Synthesis, physiochemical characterization, and 
biocompatibility of a chitosan/dextran-based hydrogel for postsurgical adhesion prevention. Journal of 
materials science Materials in medicine. Dec 2014;25(12):2743-56. doi:10.1007/s10856-014-5292-3 
17. 
Casettari L, Illum L. Chitosan in nasal delivery systems for therapeutic drugs. Journal of 
controlled release : official journal of the Controlled Release Society. Sep 28 2014;190:189-200. 
doi:10.1016/j.jconrel.2014.05.003 
18. 
Chou TC, Fu E, Wu CJ, Yeh JH. Chitosan enhances platelet adhesion and aggregation. Biochemical 
and biophysical research communications. Mar 14 2003;302(3):480-3.  
19. 
Bhaskara RS, P. SC. Use of chitosan as a biomaterial: Studies on its safety and hemostatic 
potential. Journal of Biomedical Materials Research. 1997;34(1):21-28. doi:doi:10.1002/(SICI)1097-
4636(199701)34:1<21::AID-JBM4>3.0.CO;2-P 
20. 
He Q, Gong K, Ao Q, et al. Positive charge of chitosan retards blood coagulation on chitosan 
films. Journal of Biomaterials Applications. 2013/05/01 2011;27(8):1032-1045. 
doi:10.1177/0885328211432487 
21. 
Huang TW, Wei CK, Su HW, Fang KM. Chitosan promotes aquaporin formation and inhibits 
mucociliary differentiation of nasal epithelial cells through increased TGF-beta1 production. Journal of 
tissue engineering and regenerative medicine. Dec 2017;11(12):3567-3575. doi:10.1002/term.2274 
22. 
Chung YJ, An SY, Yeon JY, Shim WS, Mo JH. Effect of a Chitosan Gel on Hemostasis and 
Prevention of Adhesion After Endoscopic Sinus Surgery. Clinical and experimental otorhinolaryngology. 
Jun 2016;9(2):143-9. doi:10.21053/ceo.2015.00591 
23. 
Mohammed M, Syeda J, Wasan K, Wasan E. An Overview of Chitosan Nanoparticles and Its 
Application in Non-Parenteral Drug Delivery. Pharmaceutics. 2017;9(4):53.  
24. 
Garth RJ, Brightwell AP. A comparison of packing materials used in nasal surgery. J Laryngol Otol. 
Jul 1994;108(7):564-6.  
25. 
Corbridge RJ, Djazaeri B, Hellier WP, Hadley J. A prospective randomized controlled trial 
comparing the use of merocel nasal tampons and BIPP in the control of acute epistaxis. Clin Otolaryngol 
Allied Sci. Aug 1995;20(4):305-7.  
26. 
von Schoenberg M, Robinson P, Ryan R. Nasal packing after routine nasal surgery--is it justified? 
J Laryngol Otol. Oct 1993;107(10):902-5.  
27. 
Kucik CJ, Clenney T. Management of epistaxis. Am Fam Physician. Jan 15 2005;71(2):305-11.  
28. 
Shikani AH, Chahine KA, Alqudah MA. Endoscopically guided chitosan nasal packing for 
intractable epistaxis. Am J Rhinol Allergy. Jan-Feb 2011;25(1):61-3. doi:10.2500/ajra.2011.25.3539 

Novapak Clinical Investigation Plan 
 
 
MDT22031 
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Page 66 of 73 
 
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29. 
Bhattacharyya N. Progress in surgical management of chronic rhinosinusitis and nasal polyposis. 
Curr Allergy Asthma Rep. Jun 2007;7(3):216-20.  
30. 
Lubianca-Neto JF, Sant'anna GD, Mauri M, Arrarte JL, Brinckmann CA. Evaluation of time of nasal 
packing after nasal surgery: a randomized trial. Otolaryngol Head Neck Surg. Jun 2000;122(6):899-901. 
doi:10.1016/S0194-59980070021-0 
31. 
Ozdogan F, Ozel HE, Esen E, et al. Optimal time for intranasal splint removal after septoplasty: a 
prospective clinical study. Eur Arch Otorhinolaryngol. Oct 2016;273(10):3203-6. doi:10.1007/s00405-
016-4004-7 
32. 
Weber R, Keerl R, Hochapfel F, Draf W, Toffel PH. Packing in endonasal surgery. American 
Journal of Otolaryngology. 2001;22(5):306-320. doi:10.1053/ajot.2001.26499 
33. 
R. W. Nasal packing and stenting. . GMS Current Topics in Otorhinolaryngology - Head and Neck 
Surgery 2009;8:1865-1901.  
34. 
Massey CJ, Singh A. Advances in Absorbable Biomaterials and Nasal Packing. Otolaryngologic 
Clinics of North America. 2017/06/01/ 2017;50(3):545-563. 
doi:https://doi.org/10.1016/j.otc.2017.01.006 
35. 
Massey CJ, Suh JD, Tessema B, Gray ST, Singh A. Biomaterials in Rhinology. Otolaryngol Head 
Neck Surg. Apr 2016;154(4):606-17. doi:10.1177/0194599815627782 
36. 
Orlandi RR, Kingdom TT, Hwang PH, et al. International Consensus Statement on Allergy and 
Rhinology: Rhinosinusitis. Int Forum Allergy Rhinol. Feb 2016;6 Suppl 1:S22-209. doi:10.1002/alr.21695 
37. 
Zhao X, Grewal A, Briel M, Lee JM. A systematic review of nonabsorbable, absorbable, and 
steroid-impregnated spacers following endoscopic sinus surgery. Int Forum Allergy Rhinol. Nov 
2013;3(11):896-904. doi:10.1002/alr.21201 
38. 
Soler ZM, Schlosser RJ. Post-fess middle meatal dressings: Avoiding the inevitable? JAMA 
Otolaryngology–Head & Neck Surgery. 2013;139(12):1351-1354. doi:10.1001/jamaoto.2013.5439 
39. 
Schlewet M CP. Effects of a plant based biodegradable middle meatal dressing after endoscopic 
sinus surgery: A prospective comparative study. Arch Otolaryngol Rhinol 2017;3(14):121-125. 
doi:http://doi.org/10.17352/2455-1759.000062 
40. 
Hsu K, Ericksen M, Catalano P. Effect of a Chitosan-Based Biodegradable Middle Meatal Dressing 
after Endoscopic Sinus Surgery: A Prospective Randomized Comparative Study. Sinusitis. 2015;1(1):3.  
41. 
Valentine R, Wormald PJ. Nasal dressings after endoscopic sinus surgery: what and why? Curr 
Opin Otolaryngol Head Neck Surg. Feb 2010;18(1):44-8. doi:10.1097/MOO.0b013e3283346f36 
42. 
Dai T, Tanaka M, Huang YY, Hamblin MR. Chitosan preparations for wounds and burns: 
antimicrobial and wound-healing effects. Expert review of anti-infective therapy. Jul 2011;9(7):857-79. 
doi:10.1586/eri.11.59 
43. 
Muzzarelli RA, Mattioli-Belmonte M, Pugnaloni A, Biagini G. Biochemistry, histology and clinical 
uses of chitins and chitosans in wound healing. Exs. 1999;87:251-64.  
44. 
Valentine R, Athanasiadis T, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel 
chitosan gel on hemostasis and wound healing after endoscopic sinus surgery. Am J Rhinol Allergy. Jan-
Feb 2010;24(1):70-5. doi:10.2500/ajra.2010.24.3422 

Novapak Clinical Investigation Plan 
 
 
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45. 
Liu L, Gao Q, Lu X, Zhou H. In situ forming hydrogels based on chitosan for drug delivery and 
tissue regeneration. Asian Journal of Pharmaceutical Sciences. 2016/12/01/ 2016;11(6):673-683. 
doi:https://doi.org/10.1016/j.ajps.2016.07.001 
46. 
Onishi H, Machida Y. Biodegradation and distribution of water-soluble chitosan in mice. 
Biomaterials. Jan 1999;20(2):175-82.  
47. 
Thanh H, Rowan V, Stephen M, Lyall H, Simon R, Peter‐John W. The efficacy of a novel 
budesonide chitosan gel on wound healing following endoscopic sinus surgery. International Forum of 
Allergy & Rhinology. 2018;8(3):435-443. doi:doi:10.1002/alr.22057 
48. 
Zheng XL, Zhao YX, Xu M. Efficacy and Safety of 3 Nasal Packing Materials Used After Functional 
Endoscopic Sinus Surgery for Chronic Rhinosinusitis: A Comparative Study in China. Medical science 
monitor : international medical journal of experimental and clinical research. Apr 25 2017;23:1992-1998.  
49. 
Athanasiadis T, Beule AG, Robinson BH, Robinson SR, Shi Z, Wormald PJ. Effects of a novel 
chitosan gel on mucosal wound healing following endoscopic sinus surgery in a sheep model of chronic 
rhinosinusitis. Laryngoscope. Jun 2008;118(6):1088-94. doi:10.1097/MLG.0b013e31816ba576 
50. 
Dailey RA, Chavez MR, Choi D. Use of a Chitosan-Based Hemostatic Dressing in 
Dacryocystorhinostomy. Ophthalmic Plastic & Reconstructive Surgery. 2009;25(5):350-353. 
doi:10.1097/IOP.0b013e3181b30108 
51. 
Kim JH, Choi SJ, Park JS, et al. Tympanic membrane regeneration using a water-soluble chitosan 
patch. Tissue engineering Part A. Jan 2010;16(1):225-32. doi:10.1089/ten.TEA.2009.0476 
52. 
Medina JG, Steinke JW, Das S. A Chitosan-Based Sinus Sealant for Reduction of Adhesion 
Formation in Rabbit and Sheep Models. Otolaryngology--head and neck surgery : official journal of 
American Academy of Otolaryngology-Head and Neck Surgery. 04/06 2012;147(2):357-363. 
doi:10.1177/0194599812443647 
53. 
Ha TN, Valentine R, Moratti S, Robinson S, Hanton L, Wormald PJ. A blinded randomized 
controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus 
surgery. International Forum of Allergy & Rhinology. 2013;3(7):573-580. doi:doi:10.1002/alr.21136 
54. 
Wedmore I, McManus JG, Pusateri AE, Holcomb JB. A special report on the chitosan-based 
hemostatic dressing: experience in current combat operations. The Journal of trauma. Mar 
2006;60(3):655-8. doi:10.1097/01.ta.0000199392.91772.44 
55. 
Achneck HE, Sileshi B, Jamiolkowski RM, Albala DM, Shapiro ML, Lawson JH. A comprehensive 
review of topical hemostatic agents: efficacy and recommendations for use. Ann Surg. Feb 
2010;251(2):217-28. doi:10.1097/SLA.0b013e3181c3bcca 
56. 
Arbel J, Rozenbaum E, Reges O, et al. USage of chitosan for Femoral (USF) haemostasis after 
percutaneous procedures: a comparative open label study. EuroIntervention. 2011/04// 2011;6(9):1104-
1109. doi:10.4244/eijv6i9a192 
57. 
Bachtell N GT, Grunkemeier G, Jin R, Gregory K. . Treatment of dialysis access puncture wound 
bleeding with chitosan dressings. . Dialysis and Transplantation 2006;35(11):672-681.  
58. 
N. B. Single Center Experience with a Novel Chitosan PEG Nasal Packing. . 58th American 
Rhinological Society - Fall 2012. 2012:Washington D.C.  
59. 
Brown MA, Daya MR, Worley JA. Experience with chitosan dressings in a civilian EMS system. 
The Journal of emergency medicine. Jul 2009;37(1):1-7. doi:10.1016/j.jemermed.2007.05.043 

Novapak Clinical Investigation Plan 
 
 
MDT22031 
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60. 
Klokkevold PR, Fukayama H, Sung EC, Bertolami CN. The effect of chitosan (poly-N-acetyl 
glucosamine) on lingual hemostasis in heparinized rabbits. Journal of oral and maxillofacial surgery : 
official journal of the American Association of Oral and Maxillofacial Surgeons. Jan 1999;57(1):49-52.  
61. 
Kourelis K, Shikani AH. Effectiveness of chitosan-based packing in 35 patients with recalcitrant 
epistaxis in the context of coagulopathy. Clin Otolaryngol. Aug 2012;37(4):309-13. doi:10.1111/j.1749-
4486.2012.02488.x 
62. 
Malmquist JP, Clemens SC, Oien HJ, Wilson SL. Hemostasis of oral surgery wounds with the 
HemCon Dental Dressing. Journal of oral and maxillofacial surgery : official journal of the American 
Association of Oral and Maxillofacial Surgeons. Jun 2008;66(6):1177-83. doi:10.1016/j.joms.2007.12.023 
63. 
Misgav M, Kenet G, Martinowitz U. Chitosan-based dressing for the treatment of 
external/accessible bleedings in children with bleeding tendency. J Pediatr Hematol Oncol. Mar 
2014;36(2):140-2. doi:10.1097/MPH.0b013e31828ac8b6 
64. 
Shikani AH CK. Chitosan nasal packing for recalcitrant epistaxis. . Laryngoscope 
2009;119((Supple 3)):S319.  
65. 
Nageh H, Ezzat M, Ghanim M, Hassanin A, Abdelmoneim A. Evaluation of antibacterial activity 
and drug release behavior of chitosan-based nanofibers (In Vitro Study). vol 2(3). 2014:01-05. 
66. 
Raafat D, von Bargen K, Haas A, Sahl H-G. Insights into the Mode of Action of Chitosan as an 
Antibacterial Compound. Applied and Environmental Microbiology. 05/02; 02/25/received; 
04/22/accepted 2008;74(12):3764-3773. doi:10.1128/AEM.00453-08 
67. 
Felice F, Zambito Y, Belardinelli E, Fabiano A, Santoni T, Di Stefano R. Effect of different chitosan 
derivatives on in vitro scratch wound assay: a comparative study. International journal of biological 
macromolecules. May 2015;76:236-41. doi:10.1016/j.ijbiomac.2015.02.041 
68. 
Chan M, Brooks HJ, Moratti SC, Hanton LR, Cabral JD. Reducing the Oxidation Level of Dextran 
Aldehyde in a Chitosan/Dextran-Based Surgical Hydrogel Increases Biocompatibility and Decreases 
Antimicrobial Efficacy. International journal of molecular sciences. Jun 16 2015;16(6):13798-814. 
doi:10.3390/ijms160613798 
69. 
Straccia MC, d'Ayala GG, Romano I, Oliva A, Laurienzo P. Alginate hydrogels coated with 
chitosan for wound dressing. Marine drugs. May 11 2015;13(5):2890-908. doi:10.3390/md13052890 
70. 
Phuong NT, Anh Ho V, Hai Nguyen D, et al. Enzyme-mediated fabrication of an oxidized chitosan 
hydrogel as a tissue sealant. Journal of Bioactive and Compatible Polymers. 2015;30(4):412-423. 
doi:10.1177/0883911515578760 
71. 
Kong M, Chen XG, Xing K, Park HJ. Antimicrobial properties of chitosan and mode of action: a 
state of the art review. Int J Food Microbiol. Nov 15 2010;144(1):51-63. 
doi:10.1016/j.ijfoodmicro.2010.09.012 
72. 
Dutta P, Tripathi S, Mehrotra G, Dutta J. Perspectives for chitosan based antimicrobial films in 
food applications. vol 114. 2009:1173-1182. 
73. 
Fouad. RDG. PhD Dissertation: Chitosan as an antimicrobial compound: Modes of action and 
resistance mechanisms. . University of Bonn, Germany. 2008; 
74. 
Mrunal. TR. Ph.D. Dissertation: Synthesis and Antibacterial Assessment of Water-Soluble 
Hydrophobic Chitosan Derivatives Bearing Quaternary Ammonium Functionality. . Louisiana State 
University. 2004.; 

Novapak Clinical Investigation Plan 
 
 
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75. 
Jeon SJ, Oh M, Yeo W-S, Galvão KN, Jeong KC. Underlying Mechanism of Antimicrobial Activity of 
Chitosan Microparticles and Implications for the Treatment of Infectious Diseases. PLOS ONE. 
2014;9(3):e92723. doi:10.1371/journal.pone.0092723 
76. 
Zheng L-Y, Zhu J-F. Study on antimicrobial activity of chitosan with different molecular weights. 
Carbohydrate Polymers. 2003/12/01/ 2003;54(4):527-530. 
doi:https://doi.org/10.1016/j.carbpol.2003.07.009 
77. Boezaart AP, Van Der Merwe J, and Coetzee A. Comparison of sodium nitroprusside and esmolol 
induced controlled hypotension for functional endoscopic sinus surgery. Can J Anaesth 42:373–
376,1995. 
78. Lund VJ, Kennedy DW. Staging for rhinosinusitis. Otolaryngol Head Neck Surg. 1997; 117(3 Pt 2): 
S35–40. [PubMed: 9334786] 
79. Lund VJ, Mackay IS. Staging in Rhinosinusitis. Rhinology, 31, 183-184, 1993 
 
 
 

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17. Appendices 
Appendix A – Foreseeable AE List 
18. Version History 
The table below contains a history of the current CIP.  
Version 
Summary of 
changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
A 
• 
Not Applicable, 
New Document 
N/A 
N/A 
N/A 
David Hodge, 
Clinical 
Research 
Program 
Manager 
 
Appendix A – Foreseeable AE List 
The information provided in this section pertains to foreseeable adverse events that may be observed in 
the Novapak Study and may collectively assist in identifying those events for a given device or therapy 
that are unexpected in nature. The foreseeable adverse events information consists of three parts: 1) 
observed adverse device effect(s) in similar Medtronic studies, 2) adverse events reported in published 
literature, and 3) additional foreseeable adverse events. An evaluation of potentially anticipated events, 
adverse device effects observed in previous clinical studies, and reported events in literature may be 
used in combination with device labeling, current event reporting information, and other published data 
to assess for an unexpected occurrence. 
The use of Novapak Nasal Sinus Packing and Stent device involves application after surgery, therefore, 
standard adverse events associated with a surgical procedure may be experienced (e.g. anesthesia 
complications, injury, infections, bleeding, exacerbation of pre-existing conditions, healing 

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complications, etc.). However, the focus of this section is to address in more detail, those events that 
are foreseeable due to the use, performance, and/or presence of the device under investigation. 
Potential risks associated with the use of the Novapak Nasal Sinus Packing and Stent device, as well as 
risk minimization are discussed within Section 10. Treatment required for procedure and/or device 
related adverse events may include medication, device removal, or other surgical and medical remedies. 
The remainder of this section provides examples of adverse event data from previous Medtronic clinical 
studies and literature. Evaluation of potentially anticipated events may involve data in this section as 
well as a thorough review of all available information (e.g. labeling, current event reporting, published 
data, etc.). 
Risks and Complications of Sinus Surgery 
Normal Expected Complications 
• 
mild bleeding 
• 
inflammation and swelling 
• 
nasal congestion  
• 
moderate pain  
• 
fatigue  
• 
mild to moderate headaches  
• 
facial pressure 
Complications that may occur  
• 
Bleeding / Hemorrhaging 
• 
Adhesions of Tissues  
• 
Scaring of Tissues 
• 
Infections 
• 
Nasal Crusting or Dryness 
• 
Loss of Smell or Taste 
• 
Cerebral Spinal Fluid Leak 
• 
Empty Nose Syndrome 
• 
Damage to the Ocular Orbit 
• 
Numbness of the Teeth or Palate 
• 
Septal Perforation 
• 
Return of Symptoms / Obstruction 
• 
Anesthesia Related Risks 
Risks Associated with Nasal Packing 

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Nasal sinus packing in general has tried to address these surgical complications but may result in risks 
that are specific to the use of packing, as follows: 
• 
Bleeding – present if packing is inadequate or bleeding is excessive– may require post-operative 
controls (e.g., suturing, cautery, more packing)  
• 
Adhesions – present if packing is inadequate to separate tissue compromised due to surgical 
trauma – requires post-operative debridement of tissues which may lead to bleeding. 
• 
Scarring - This risk is where the tissue heals abnormally  
• 
Infection – due to introduction of bacterial during the surgery and/or if sterility is breached - 
packing could encourage bacterial growth if design controls are not in place to control bacterial 
growth. 
• 
Toxic Shock Syndrome –defined as “A severe illness caused by infection with staphylococcus 
aureus and characterized by high fever of sudden onset, vomiting, diarrhea, and myalgia, 
followed by hypotension and in severe cases, shock; a sunburn like rash with peeling of the skin, 
especially of the palms and soles, occurs during the acute phase.” 
• 
Respiratory Obstruction – physical obstruction of the breathing pathway – This harm may occur 
from stent migration and cause difficulty breathing (i.e., hypoxia, dyspnea) 
• 
Aspiration of the packing – causes respiratory obstruction with tachypnea can lead to aspiration 
pneumonia, urgent medical intervention may be necessary 
• 
Pneumonia - If the stent were aspirated, pneumonia may occur. The patient may be treated 
with IV medication. 
• 
Potential toxicity reactions – components of the packing could lead to a toxicity reaction due to 
a non-biocompatibility reaction occurring, but the reaction would not be expected to go beyond 
an inflammatory response. (i.e., redness, swelling, etc.) 
• 
Potential allergic hypersensitivity reactions – components of the packing could lead to an 
allergic hypersensitivity reaction - A patient may experience edema and difficulty breathing with 
IV medications used as medical intervention. 
• 
Foreign Body Reaction - Potential tissue interactions with packing components, fragments, or 
surface texture. In addition to an inflammatory response, it usually includes the formation of a 
foreign body granuloma, or encapsulation around a foreign object. Medical intervention may be 
taken to remove the product. 
• 
Inflammation - This harm includes local irritation from the product. This risk may require Oral 
medication to reduce inflammatory response. 
• 
Fever - A medium-low grade fever may develop. This risk may require Oral medication to reduce 
inflammatory response. 
• 
Device Fragments in Patient – If a device fragments migration of pieces of the stent could result 
in possible medical intervention needed 
• 
Pain – during post-operative removal of non-dissolving packing devices most patients have 
reported some mild temporary pain. 

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• 
Decreased Therapeutic Response – The packing may not perform as expected and not control 
the risks as intended.  It would not result in surgical correction but may require a minor medical 
intervention. 
 
Current Reported Patient Injury Complaints Related to Novapak Device 
The use of the Novapak Nasal Sinus Packing and Stent may involve the risks listed above for all packing 
type devices, with the exception of pain upon removal, since it dissolves away with irrigation. There may 
be other discomforts and risks related to the Novapak Nasal Sinus Packing and Stent device and/or this 
study that are not foreseen at this time. 
These are the current risks of Novapak seen in the field based on reports to our complaint system: 
(number of reported events as of June 24, 2022) 
• 
Irritation – potential shellfish hypersensitivity (1) 
• 
Post-operative bleeding requiring secondary controls (3) 
• 
Post-operative device migration to oral cavity (1) 
• 
Post-operative edema and pain (2) 
 
Observed Adverse Device Effect in Previous Clinical Studies 
There have been no previous clinical studies with the use of Novapak Nasal Sinus Packing and Stent 
device.