A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair
Phase: NA
Conditions: Ventral Hernia
Sponsor: Medtronic - MITG

Parietene™ DS Composite Mesh in Ventral Hernia 
Repair Clinical Investigation Plan 
 
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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  A multi-center post-market single arm 
prospective study of Parietene™ DS Composite 
Mesh in subjects undergoing ventral hernia repair 
Clinical Investigation Plan Identifier MDT17051PDS 
Study Product Name Parietene™ DS Composite Mesh 
Sponsor/Local Sponsor Covidien-Medtronic 
Minimally Invasive Therapies Group Surgical 
Innovations 
15 Hampshire St 
Mansfield, MA, 02048  
USA  
Document Version 4.0 
Version Date 03 December 2021 
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. 
 
Covidien LP and Sofradim Production are indirect wholly owned subsidiaries of Medtronic plc. 
 
 
 

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1. Investigator Agreement and Signature Page  
  
Study Product Name 
Parietene™ DS Composite Mesh 
Sponsor 
Covidien-Medtronic 
Minimally Invasive Therapies 
Group 
Surgical Innovations 
 15 Hampshire St 
Mansfield, MA, 02048 
USA 
Clinical Investigation Plan Identifier 
MDT17051PDS 
Version Number / Date  
4.0, 03 DEC 2021 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for 
me and my staff to conduct this study as described. I will conduct this study as outlined herein and 
will make a reasonable effort to complete the study within the time designated. 
 
I agree to comply with the International Conference on Harmonization Guidelines on Good Clinical 
Practice, United States Food and Drug Administration regulations. I agree to ensure that the 
confidential information contained in this document will not be used for any purpose other than the 
evaluation and conduct of the clinical investigation without the prior written consent of Medtronic. 
 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
Investigator’s Signature: 
 
Investigator’s Name: 
 
Institution: 
 
Date:  
 
 
 
 

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Table of Contents 
1. Investigator Agreement and Signature Page ........................................................................ 2 
Table of Contents ...................................................................................................................... 3 
2. Glossary ................................................................................................................................. 7 
3. Synopsis ................................................................................................................................. 9 
4. Introduction ......................................................................................................................... 14 
4.1 Background ...................................................................................................................... 14 
4.2 Purpose............................................................................................................................ 15 
5. Objectives and Endpoints .................................................................................................... 15 
5.1 Objectives ........................................................................................................................ 15 
5.1.1 
Primary Objective ................................................................................................... 15 
5.1.2 
Secondary Objective ............................................................................................... 15 
5.2 Endpoints ......................................................................................................................... 15 
5.2.1 
Primary Endpoint .................................................................................................... 15 
5.2.2 
Secondary Endpoint ................................................................................................ 15 
6. Study Design ........................................................................................................................ 16 
6.1 Duration ........................................................................................................................... 16 
6.2 Rationale .......................................................................................................................... 16 
6.3 Study Oversight ................................................................................................................ 17 
7. Product Description ............................................................................................................. 17 
7.1 General ............................................................................................................................ 17 
7.2 Manufacturer .................................................................................................................... 18 
7.3 Packaging ......................................................................................................................... 19 
7.4 Intended Population .......................................................................................................... 19 
7.5 Product Use ...................................................................................................................... 19 
7.5.1 
Summary of Operating Steps ................................................................................... 19 
7.6 Product Training Requirements ........................................................................................... 20 
7.7 Product Receipt and Tracking ............................................................................................. 20 
7.8 Product Return .................................................................................................................. 20 
7.9 Product Accountability ....................................................................................................... 21 
8. Study Site Requirements ..................................................................................................... 21 
8.1 Investigator/Investigation Site Selection .............................................................................. 21 

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9. Selection of Subjects ........................................................................................................... 21 
9.1 Study Population ............................................................................................................... 21 
9.2 Subject Enrollment ............................................................................................................ 22 
9.3 Inclusion Criteria ............................................................................................................... 22 
Pre-Operative Inclusion Criteria ................................................................................................. 22 
9.4 Exclusion Criteria ............................................................................................................... 22 
Pre-Operative Exclusion Criteria................................................................................................. 22 
Intra-Operative Exclusion Criteria .............................................................................................. 23 
10.
Study Procedures.......................................................................................................... 24 
10.1   Schedule of Events .......................................................................................................... 24 
10.2   Subject Screening (Day -30 to 0) ...................................................................................... 25 
10.3   Subject Consent .............................................................................................................. 25 
10.4   Operative (Day 0)............................................................................................................ 26 
10.4.1 
Discharge Assessment ............................................................................................. 26 
10.4.2 
1-Month Follow-up (+/- 14 Days) Visit ...................................................................... 27 
10.4.3 
3-Month Follow-up (+/- 14 Days) Visit ...................................................................... 27 
10.4.4 
12-Month and 24-Month Follow-up (+/- 30 Days) Visit ................................................ 27 
10.5   Unscheduled Follow-up Visits ............................................................................................ 27 
10.6   Conducting Remote Subject Follow-up Visits ....................................................................... 28 
10.6.1 
Protocol Deviations and Remote Follow-up ................................................................ 28 
10.6.2 
Subject Compensation and Remote Follow-up ............................................................ 29 
10.7   Randomization and Treatment Assignment ......................................................................... 29 
10.7.1 
Blinding ................................................................................................................. 29 
10.8    Assessment of Efficacy .................................................................................................... 29 
10.9    Assessment of Safety ...................................................................................................... 29 
10.10  Recording Data .............................................................................................................. 29 
10.11  Deviation Handling ......................................................................................................... 29 
10.12  Subject Exit, Withdrawal or Discontinuation ....................................................................... 30 
10.12.1 
Enrolled ................................................................................................................. 30 
10.12.2 
Screen Failure ........................................................................................................ 30 
10.12.2.1 
Prior to Surgery………………………………………………………………………………………...30 
10.12.2.2 
During Surgery………………………………………………………………………………………….30 

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10.12.3      Study Exit……………….……………………………………………………………………………………….30 
10.12.4      Withdrawal………….…………………………………………………………………………………………..31 
10.12.5      Lost to Follow-Up (LTFU)………….……………………………………………………………………...31 
11.
Risks and Benefits ........................................................................................................ 32 
11.1   Potential Risks ............................................................................................................... 32 
11.2   Potential Benefits ........................................................................................................... 32 
11.3   Risk Minimization............................................................................................................ 32 
12.
Adverse Events and Device Deficiencies ...................................................................... 33 
12.1   Adverse Events .............................................................................................................. 33 
12.2   Device Deficiencies ......................................................................................................... 34 
12.3   Definitions and Classifications .......................................................................................... 34 
12.4   Evaluation and Documentationof Adverse Events and Device Deficiencies ............................. 35 
12.5   Adverse Event and Device Deficiency Classification............................................................. 39 
12.5.1 Adverse Event Relationship Classification…………………………………………………………………..36 
12.6  Adverse Event and Device Deficiency Reporting Requirements………………………………………..….38 
12.7  Study Contact Information…………………………………………………………………………………………..….39 
12.8   Product Complaint Reporting……………………………………………………………………………………………39 
13.
Data Review Committees ............................................................................................. 40 
13.1   Independent Medical Monitor ........................................................................................... 40 
14.
Statistical Design and Methods .................................................................................... 40 
14.1   Statistical Test Methods & Analysis Populations .................................................................. 40 
14.2   Interim Analysis ............................................................................................................. 41 
14.3   Statistical Analysis Endpoints ........................................................................................... 42 
14.3.1 
Primary Endpoint .................................................................................................... 42 
14.3.2 
Secondary Endpoints ............................................................................................... 42 
14.4   Safety Assessment ......................................................................................................... 42 
14.5   Sample Size Determination .............................................................................................. 43 
14.6   Handling of Missing Data ................................................................................................. 43 
15.
Ethics ............................................................................................................................ 43 
15.1   Statement(s) of Compliance ............................................................................................ 43 
16.
Study Administration .................................................................................................... 44 
16.1  Monitoring ....................................................................................................................... 44 

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16.2   Data Management .......................................................................................................... 45 
16.3   Direct Access to Source Data/Documents .......................................................................... 45 
16.4   Confidentiality ................................................................................................................ 45 
16.5   Liability ......................................................................................................................... 46 
16.6   Clinical Investigation Plan (CIP) / Protocol Amendments ..................................................... 46 
16.7   Record Retention ........................................................................................................... 46 
16.8   Publication and Use of Information ................................................................................... 46 
16.9   Suspension or Early Termination ...................................................................................... 47 
17.
References .................................................................................................................... 48
18.
Appendices ................................................................................................................... 49 
18.1   APPENDIX A: List of Investigators and Institutions ............................................................. 49 
18.2   APPENDIX B: Carolinas Comfort Scale™ ............................................................................ 50 
18.3   APPENDIX C: Centers for Disease Control (CDC) Would Class .............................................. 52 
18.4   APPENDIX D: Parietene™ DS Composite Mesh Instructions for Use ...................................... 53 
19.
Version History ............................................................................................................. 55 

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2. Glossary 
Term 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
“Bridging” repair 
technique with the 
mesh placed in an 
“inlay” position 
“Bridging” repair technique with the mesh placed in an “inlay” position is 
defined as cutting mesh to the size of the defect, positioning the mesh in 
the abdominal wall defect and then suturing the edges of the mesh to the 
edges of the defect. 
BMI 
Body Mass Index, calculated as per kg/m2 (Kg is person’s weight in Kg and 
m is the height in meters) 
CDC 
Centers for Disease Control and Prevention (USA) 
CI 
Confidence Interval 
CIP 
Clinical Investigation Plan (can be used synonymously with Protocol) 
DD 
Device Deficiency 
eCRF 
Electronic Case Report Form 
FAS 
Full Analysis Set – An analysis set including any subjects enrolled and 
receiving study device 
General Surgeon 
A surgeon who has received a “basic certificate”, commonly referred to as 
“General Surgery Certificate” 
GCP 
Good Clinical Practice 
Hernia Recurrence 
A clinically manifested bulge or a protrusion exacerbated by a Valsalva 
maneuver 
ICMJE 
International Committee of Medical Journal Editors 
ICH 
International Conference on Harmonization 
IFU 
Instructions for Use 
Incisional Ventral 
Hernia 
A ventral hernia that developed after surgical trauma to the abdominal 
wall, including recurrences after repair of primary ventral hernias. (1) 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 

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Term 
Definition 
MedDRA 
Medical Dictionary for Regulatory Activities 
Parastomal Hernia 
An incisional hernia through the abdominal wall defect created during 
placement of a colostomy, ileostomy, or ileal conduit stoma 
PMCF 
Post Market Clinical Follow-Up 
PPAS 
Per Protocol Analysis Set – An analysis set consisting of a subset of the full 
analysis set of subjects who meet the primary endpoint (12-month 
assessment) and who did not deviate (major) from the protocol 
Primary Ventral Hernia 
A primary ventral hernia is a ventral hernia that was present at birth or that 
developed spontaneously without trauma to the abdominal wall as the 
cause of the hernia. (1) 
QOL 
Quality of Life 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
USA 
United States of America 
Ventral Hernia 
A ventral hernia is a hernia of the abdominal wall excluding the inguinal 
area, the pelvic area, and the diaphragm. (1) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3. Synopsis 
 
Title 
A multi-center post-market single arm prospective study of Parietene™ DS 
Composite Mesh in subjects undergoing ventral hernia repair 
Clinical Study Type 
Post-Market Study 
Product Name 
Parietene™ DS Composite Mesh  
Sponsor  
Covidien-Medtronic 
Minimally Invasive Therapies Group  
Surgical Innovations 
15 Hampshire St 
Mansfield, MA, 02048 
USA 
Indication Under 
Investigation 
Parietene™ DS Composite Mesh is indicated for the repair of ventral hernias. 
This on label indication will be investigated during this study. 
Investigation 
Purpose 
To confirm the clinical safety and performance of Parietene™ DS Composite 
Mesh in the short (1, 3 months), mid (12 months) and long term (24 months) 
when used for the repair of ventral hernias. 
Product Status 
Parietene™ DS Composite Mesh received 510(k) clearance by the FDA (USA) in 
June 2017. (K163212) 
Primary Objective 
The primary objective of this study is to assess hernia recurrence, within 12 
months following the use of Parietene™ DS Composite Mesh in ventral hernia 
repair. 
Secondary Objective 
The secondary objective of this study is to assess clinical outcomes, within 24 
months following the use of Parietene™ DS Composite Mesh in ventral hernia 
repair. 
Study Design 
This study is a single arm, prospective, multi-center, observational, post- 
market study to confirm the clinical safety and performance of Parietene™ 
DS Composite Mesh in ventral hernia repair. 
 
After IRB approvals, subjects who have signed an informed consent form 
(and who meet the eligibility criteria) and have received Parietene™ DS 
Composite Mesh will be enrolled in the study. Subjects will undergo elective 
ventral hernia repair using Parietene™ DS Composite Mesh and be 
evaluated pre- operatively, at the procedure, at discharge, within 1 month, 
3 months, 12 months, and 24 months post-surgery. 
 
An interim analysis based on 30 subjects with complete 3-month visits to 
assess the short-term safety of the device will be used to support regulatory 

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approval. Study enrollment will continue during interim analysis. The study 
will continue as a post market clinical follow-up (PMCF) with extended follow-
up of subjects to assess the mid (12 months) and long (24 months) term safety 
and performance of the device. The study will include a minimum of 125 
subjects who will be followed 24 months post-surgery. Subject participation in 
the study will last a maximum of 26 months and overall, the study is 
estimated to proceed for up to 38 months. 
Primary Endpoint 
Incidence of hernia recurrence within 12 months following Parietene™ DS 
Composite Mesh use in ventral hernia repair 
Secondary 
Endpoints 
The secondary endpoints will include: 
- Incidence of adverse device effects (ADEs) intra-operatively, at discharge, 
within 1 month, 3 months, 12 months, and 24 months following Parietene™ 
DS Composite Mesh use in ventral hernia repair 
- Incidence of hernia recurrence at 1, 3 and 24 months. The evaluation of 
hernia recurrence will be performed during a physical examination 
- Time to hernia recurrence and time to adverse device effect occurrence 
(from surgery time-point) 
- Carolinas Comfort Scale™ QOL questionnaire completed pre-operatively and 
at 1, 12 and 24 months postoperatively 
Randomization 
Study will not utilize any randomization or blinding 
Sample Size 
125 male or female adult subjects will be enrolled in a minimum of 4 USA sites 
who are undergoing elective ventral hernia repair 
Inclusion/Exclusion 
Criteria 
Subjects are eligible to be enrolled in the study only if they meet all of 
the following criteria: 
Pre-Operative Inclusion Criteria 
1. Subject has provided informed consent 
2. Subject is ≥18 years of age (at the time of consent) 
3. Subject is undergoing elective ventral hernia repair 
(primary or incisional) with intraperitoneal mesh placement 
Subjects will be excluded from the study if they meet any of the 
following criteria: 
Pre-Operative Exclusion Criteria 
1. BMI > 45 kg/m2 
2. Subject is undergoing emergency surgery 
3. Subject is pregnant or planning to become pregnant during 
study participation period 
4. Subject is unable or unwilling to comply with the study 
requirements or follow-up schedule 
5. Subject has comorbidities which, in the opinion of the Investigator, 

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will not be appropriate for the study or the subject has an 
estimated life expectancy of less than 6 months 
6. The subject has participated in another investigational drug or 
device research study within 30 days of enrollment 
7. Subject has a parastomal hernia 
Intra-operative Exclusion Criteria 
1. Subject’s hernia repair is in a contaminated or infected site (CDC 
wound class 2-4; Section 17.2) as assessed by the Investigator(s) 
2. Subject is undergoing “bridging” repair technique with the 
mesh placed in an “inlay” position 
3. Surgeon is unable to completely remove existing mesh from 
prior surgery 
4. Surgeon overlays 2 meshes 
Subject receives any mesh other than Parietene™ DS composite mesh 
Study Procedures 
and Assessments 
Subjects will be evaluated pre-operatively, during the procedure, at 
discharge, within 1 month, 3 months, 12 months, and 24 months post-
procedure via in person visit or remote follow-up. 
Assessments to be conducted/data collected include: 
Pre-operative data (Day -30 to 0): 
• 
Eligibility criteria 
• 
Subject demographics 
• 
Informed consent 
• 
Pregnancy status 
• 
Medical and abdominal surgical history and relevant risk factors 
• 
Carolinas Comfort Scale™ QOL questionnaire – Pre-Operative 
assessment 
Operative data (Day 0): 
• 
Eligibility criteria (Intra-operative criteria) 
• 
Pregnancy status 
• 
Hernia defect description 
• 
Recurrence history, if applicable 
• 
Date of surgery, Operative time 
• 
Condition of Anesthesia / ASA Grade 
• 
Intraoperative wound contamination class (CDC classification) 
• 
Indication for ventral hernia surgery 
• 
Type of access, defect closure and surgical technique approach 
• 
Mesh size, mesh shape, lot number, positioning, and fixation 
• 
Antibiotic prophylaxis 

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• 
Area of mesh overlap 
• 
Adverse events assessment 
• 
Surgeon satisfaction questionnaire 
Discharge Data: 
• 
Adverse events assessment 
• 
Length of hospital stay 
1 Month Follow-up (± 14days) 
• 
Hernia recurrence/reoperation 
• 
Adverse events assessment  
• 
Carolinas Comfort Scale™ QOL questionnaire - Post-
Operative assessment 
• 
Adverse events assessment 
3 Month Follow-up (± 14 days)  
• 
Hernia recurrence/reoperation 
• 
Adverse events assessment 
12 Month and 24 Month Follow-ups (± 30 days) 
• 
Hernia recurrence/reoperation 
• 
Adverse events assessment 
• 
Carolinas Comfort Scale™ QOL questionnaire - Post-Operative 
assessment 
Safety Assessments 
All intra-operative and post-operative adverse events will be reported in the 
eCRF database. Listings of AEs will be generated including event description, 
severity and seriousness, relation to procedure, relation to the device and 
outcome. Adverse events will be reported to IRBs and regulatory authorities 
in accordance with the local IRB regulations and FDA regulations. 
 Statistics 
Sample size 
 
Sample size has been determined based on an acceptable level of accuracy 
for the estimated rate of hernia recurrence at 12 months (primary 
endpoint). 
 
Previous studies of the predicate device (Proceed™ Surgical mesh) with 
similar study indications, population, and design (prospective study with a 
long-term follow-up with more than 100 subjects), have reported the 
incidence of recurrence at 12 months to range from 3.5% to 5.2%.* 
 

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95% confidence intervals obtained from incidence rates between 3.5% and 
5.2% with N=100 subjects are shown below. Precision of the recurrence rates 
range from ± 3.6% to ± 4.4% as the recurrence rate increases. 
Recurrence rate at 12-month 
3.5% 
4.0% 
4.5% 
5.2% 
N 
100 
100 
100 
100 
95% CI 
[0.0 % - 7.1 %] 
[0.2% - 
[0.4% - 8.6%] [0.8% - 9.6%] 
accuracy (+/-) 
3.6% 
3.8% 
4.1% 
4.4% 
Anticipating an attrition rate of 20% at 12 months, 125 subjects will 
be enrolled for this study. 
Statistical methods & Analysis Populations 
Statistical analysis (mainly descriptive) for primary and secondary endpoints 
will be performed on the Full Analysis Set (FAS, including any subject 
enrolled and receiving study device) and on the Per Protocol Analysis Set 
(PPAS, a subset of the FAS of subjects who meet the primary endpoint and 
who did not deviate (major deviation from the protocol), for confirmatory 
analysis. 
- 
Continuous variables will be summarized using counts, means, 
standard deviations, medians, minimum and maximum. Categorical 
variables will be summarized using frequencies and percentages. 
- 
Time to events analyses using Kaplan Meier estimates and curve 
will be performed for time to recurrence or to adverse event 
occurrence 
Statistical analysis will be performed using SAS version 9.4 and 
Minitab® Version 15.0. 
Interim Analyses (During which enrollment will continue) 
- 
Upon data entry of 30 subject’s completion at 3-month follow-up 
- 
Upon data entry of subjects at 12-month follow-up 
 
 
 
*Berrevoet et al., 2009, Berreveot et al., 2014 

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4. 
Introduction 
4.1 Background 
A ventral hernia is a hernia of the abdominal wall excluding the inguinal area, pelvic area, and the 
diaphragm (1). It is comprised of an abnormal protrusion of abdominal cavity contents or pre-peritoneal 
fat through a defect or weakness in the abdominal wall. Hernias may occur spontaneously (primary 
hernia) or at the site of a previous surgical incision (incisional hernia). 
Hernias can only be repaired by surgical procedure (2). Operative repair of abdominal wall hernias forms 
a part of the daily routine practiced by every general and visceral surgeon. Approximately 4 million 
laparotomies are performed in the United States annually, up to 30%- 45% of them resulting in incisional 
hernia (3). Approximately 250,000 ventral incisional hernia repairs are performed annually in the United 
States (4-6). The repair of ventral hernias can be performed through either an open or a laparoscopic 
technique by a simple interrupted suture repair or a mesh repair. 
Use of prosthetic mesh repair is considered as standard of care for ventral hernia treatment (7). 
Depending on the surgical technique, the mesh may be implanted either in an intraperitoneal position, 
or outside of the abdominal cavity, such as onlay or inlay techniques. Surgical meshes are medical 
devices used to provide additional support to weakened or damaged tissue. The majority of surgical 
mesh devices currently available for use are constructed from synthetic materials and/or animal tissue. 
The mode of action of the mesh primarily relies on the strength provided by the structural component 
of the implant, i.e., the textile/tissue structure. The surgical mesh is intended to be progressively 
colonized by the host tissue following the cascade of biological mechanisms inherent to the wound 
healing and soft tissue remodeling, so that the mesh will ensure a long-term reinforcement of soft 
tissues. 
Currently, various surgical mesh designs exist to accommodate the variety of surgical techniques in soft 
tissue repair and reconstruction by open and laparoscopic surgeries. In particular, composite meshes 
such as Parietene™ DS Composite Mesh, are composed of a textile with a temporary adhesion barrier on 
one side to allow intraperitoneal mesh placement during abdominal wall surgery while minimizing tissue 
attachment to the mesh in case of direct contact with the viscera. 
The development of Parietene™ DS Composite Mesh relies on the long-term knowledge acquired by 
Medtronic in the development of surgical mesh for a variety of soft tissue repair procedures and the 
processing of implantable absorbable polymers. Parietene™ DS Composite Mesh was specifically 
developed as a fully synthetic alternative to the composite meshes currently available. 
Medtronic has conducted a biocompatibility evaluation of Parietene™ DS Composite Mesh, compliant 
with the standard EN ISO 10993-1 (2009), which demonstrates the biological safety of the device. Pre- 
clinical animal testing comparing of Parietene™ DS Composite Mesh and Proceed™ Surgical Mesh 
(Studies 197164, 197165 and 198929), its predicate device, demonstrate that Parietene™ DS Composite 

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Mesh achieves at least equivalent performance in terms of tissue integration and minimizing tissue 
attachment in case of contact to the viscera. 
4.2 Purpose 
The purpose of this study is to confirm the clinical safety and performance of Parietene™ DS Composite 
Mesh in the short (1-month and 3-months), mid (12-months) and long term (24-months) when used for 
the repair of ventral hernias. 
5. Objectives and Endpoints 
5.1 Objectives 
5.1.1 Primary Objective 
The primary objective of this study is to assess hernia recurrence, within 12-months following the use of 
Parietene™ DS Composite Mesh in ventral hernia repair. 
5.1.2 Secondary Objective 
The secondary objective of this study is to assess clinical outcomes, within 24-months following the use 
of Parietene™ DS Composite Mesh in ventral hernia repair. 
5.2 Endpoints 
5.2.1 Primary Endpoint 
Incidence of hernia recurrence within 12-months following Parietene™ DS Composite Mesh use in 
ventral hernia repair. 
Hernia recurrence is defined as: A clinically manifested bulge or a protrusion exacerbated by a Valsalva 
maneuver. The evaluation of hernia recurrence will be performed during a physical examination and 
confirmed per site standard of care if necessary. 
5.2.2 Secondary Endpoint 
The secondary endpoints will include: 
- 
Incidence of adverse device effects (ADEs) intra- operatively, at discharge, within 1-month, 3-
months, 12-months, and 24-months following Parietene™ DS Composite Mesh use in ventral 
hernia repair 
- 
Incidence of hernia recurrence at 1, 3 and 24 months. The evaluation of hernia recurrence will 
be performed during a physical examination 

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- 
Time to hernia recurrence and time to adverse device effect occurrence 
(from surgery time- point) 
- 
Carolinas Comfort Scale™ QOL questionnaire completed pre-operatively and at 1, 12 and 24 
months post-operatively (Section 17.2) 
6. Study Design 
This study is a USA based, single arm, prospective, multi-center, observational investigation to confirm 
the clinical safety and performance of Parietene™ DS Composite Mesh in ventral hernia repair. 
After IRB approvals, subjects who have signed an informed consent form (who meet the eligibility 
criteria) and have received Parietene™ DS Composite Mesh will be enrolled in the study. Subjects will 
undergo elective ventral hernia repair using Parietene™ DS Composite Mesh and be evaluated pre- 
operatively, at the procedure, at discharge, within 1-month, 3-months, 12-months, and 24-months post- 
surgery. 
An interim analysis based on 30 subjects with completed 3-month visits will assess the short-term safety 
of the device and will be used to support regulatory submission. Study enrollment will continue during 
interim analysis. The study will continue as a post market clinical follow-up (PMCF) with extended 
follow-up of subjects to assess the mid (12-months) and long (24-months) term safety and performance 
of the device. The study will include a minimum of 125 subjects in a minimum of 4 sites who will be 
followed 24 months post-surgery. 
6.1 Duration 
The duration of the study is estimated to be up to 38 months. Screening for subject eligibility may occur 
up to 30 days (inclusive) prior to the procedure and post-procedure subjects will be assessed at 
discharge, 1 month, 3 months, 12 months, and 24 months. In total subjects will participate in the study 
for a maximum of approximately 26 months (not including hospital stay). 
6.2 Rationale 
Parietene™ DS Composite Mesh was 510(k) Cleared by the FDA (USA) in June 2017 (K163212). 
To assess short-, mid- and long-term clinical outcomes following use of Parietene™ DS Composite Mesh 
in ventral hernia repair, Medtronic is performing a prospective study in the US. Following Parietene™ DS 
Composite Mesh use, incidence of hernia recurrence and adverse device effects will be followed for 24 
months. Currently there are no known factors (apart from those identified in the IFU) that may 
compromise study outcomes or the interpretation of results (e.g., baseline characteristics, the use of 
other study products, or subject-related factors such as age, gender, or lifestyle). If any adverse device 
effect occurrences are identified they will be assessed, reported, and documented in the eCRF. 

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6.3 Study Oversight 
This study will utilize a Steering Committee. The Steering Committee advises on the scientific content of 
the study and provides input for execution. Members will be study site investigators. The purpose of the 
Steering Committee is to make recommendations on the conduct of the study, the analysis of data, and 
the communication of results in alignment with the Medtronic Publication and Authorship Policy as well 
as the Development of Clinical Publications standard operating procedures. The Steering Committee 
may also review aggregate adverse event data on an as needed basis. As membership may change, the 
current list of members can be made available upon request. 
7. Product Description 
7.1 General  
Parietene™ DS Composite Mesh is designed to be placed in an intraperitoneal site by a laparoscopic or 
open approach. The mesh is composed of a permanent macroporous polypropylene textile on one side 
and a fully absorbable synthetic film on the other side. The film is adhered to the textile using a binding 
agent localized on the textile fibers. A violet marking is positioned on the mesh to help center and orient 
the mesh. Two non-absorbable pre-placed sutures are tied to the mesh to guarantee side 
differentiation. 
• 
The macroporous textile is knitted from a permanent monofilament polypropylene yarn. This 
macroporous polypropylene textile, commercialized by Medtronic since 2014 (ie: Parietene™ 
macroporous mesh) was chosen for its optimized mesh performance that offers balanced 
mechanical properties meeting physiological needs – without any compromise on mesh 
resistance – and acceptable tissue integration. 
• 
The synthetic film is made of an absorbable synthetic copolymer of glycolide, caprolactone, 
trimethylene carbonate, and lactide which is a polymer produced by Medtronic and clinically 
used since 2002 in the absorbable suture Caprosyn™. 
• 
The binding agent and the violet marking are made of absorbable polycaprolactone. The D&C 
Violet No. 2 dye is used for the marking. The violet dye (D&C Violet No. 2) is used in the 
absorbable components of the device Parietex™ Composite Ventral Patch, which is marketed 
by Medtronic since 2012. 
• 
The pre-placed sutures are made of an isotactic crystalline stereoisomer of polypropylene (a 
synthetic linear polyolefin) and polyethylene. The Copper Phthalocyanine Blue is used to color 
the sutures. These pre-placed sutures are Surgipro™ sutures which are manufactured by 
Medtronic have been and clinically used for more than 20 years. 
• 
The permanent macroporous textile is designed to be placed over the abdominal wall to 

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ensure long term reinforcement of soft tissues, while the continuous absorbable film is 
designed to minimize tissue attachment to the mesh in case of direct contact with the viscera. 
The absorbable film is degraded within 105 days by hydrolysis. 
It is estimated that 125 Parietene™ DS Composite Mesh devices will be used for this study. 
 
 
 
Figure 1. Parietene™ DS Composite Mesh 
The product is available in multiples shapes with the 
following sizes: 
Rectangular 
with round 
edges 
Number of 
products per 
box 
Circle 
Number of 
products per 
box 
10x15cm 
1 or 3 
Round 12cm 
1 or 3 
15x20cm 
1 or 3 
Round 15cm 
1 or 3 
20x25cm 
1 
20x30cm 
1 
30x35cm* 
1 
*This mesh size can be used if it becomes available during the course of the 
study. 
 
7.2 Manufacturer 
Parietene™ DS Composite Mesh is manufactured by Sofradim Production, (wholly owned subsidiary of 
Medtronic plc.) in Trévoux, France. 

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7.3 Packaging 
The device is provided in a single sterile package that includes an expiration date and lot number and is 
intended for single use only.  
7.4 Intended Population 
Parietene™ DS Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a 
weakness exists. It is indicated for the repair of ventral hernias in accordance with the IFUs. Parietene™ 
DS Composite Mesh is not intended for the repair of parastomal hernias. Contraindications can be found 
in the device instructions for use.  
7.5 Product Use 
The Study Investigator(s) should use Parietene™ DS Composite Mesh according to the instructions for 
use (Section 17.4). 
7.5.1 Summary of Operating Steps 
1. Parietene™ DS Composite Mesh can be trimmed to the desired size. 
a. CAUTION: The pre-placed sutures are necessary to guarantee sides differentiation when 
deploying the mesh. If it is required to trim the device, ensure that the pre-placed 
sutures remain on the device. When trimming, the central marking may no longer be 
centered. 
2. Should it be used in a laparoscopic approach, Parietene™ DS Composite Mesh can be rolled on 
either side (film side or textile side) without damaging the device. 
a. To facilitate mesh deployment within the abdominal cavity, it is suggested to roll the 
Parietene™ DS Composite Mesh with the film inside. 
b. It is recommended to introduce a mesh of size up to 20 x 15 cm in a trocar with 
minimum internal diameter of 10 mm, a mesh of size up to 30 x 20 cm in a trocar with 
minimum internal diameter of 12 mm. Mesh insertion capability may vary depending on 
rolled mesh size and graspers/trocars used. 
c. CAUTION: Do not force the mesh through the trocar. Inappropriate insertion may lead 
to textile and/or film damage. The meshes equal or larger than 35 x 30 cm are not 
designed for laparoscopic use. 
3. The textile side (the porous side) should be placed against the abdominal wall for tissue 
integration, while the film side (the smooth side) should be facing the viscera to minimize tissue 
attachment. 

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4. The pre-placed sutures are positioned on the textile side to help with the mesh handling once it 
is unrolled in the abdominal cavity. These yarns allow to easily pinpoint the mesh textile side. 
They can be used for the transparietal fixation of the mesh. 
a. CAUTION: If the pre-placed sutures are not used for transparietal fixation, do not 
remove them until the placement of the mesh is secured. 
5. The device should be centered on the defect. The central marking is designed to help centering. 
Use the violet dots on the mesh to facilitate its placement and orientation. 
6. The choice of mesh size is determined by the surgeon. The edge of the mesh should be at least 3 
cm over the edges of the defect(s). 
NOTE: The distance between two violet dots is approximately 2.5 cm. 
7. The technique used to anchor the mesh (suture and/or tack) is left up to the practitioner. 
If the pre-placed sutures are used for transparietal fixation, it must be combined with standard 
fixation means (suture and/or tack) to guarantee a secured mesh fixation. It is suggested to 
fixate the mesh to the abdominal wall at a distance of approximately 1 cm from the edge of the 
mesh. A moderate and equal tension should be applied in all directions for fixation in order to 
account for wound shrinkage during the healing process and to prevent damage to the mesh. 
For study purpose, it is recommended a minimum of 5 cm mesh overlap beyond the edges of the defect. 
In all study cases, every effort should be made to close the defect. 
If barbed sutures are used for fixation, these sutures must have the specific indication for mesh fixation. 
7.6 Product Training Requirements 
Each Investigator participating in the clinical study and the associated clinical study staff will receive 
training on the clinical protocol, as well as Parietene™ DS composite mesh. Investigator(s) and study 
staff will be trained on device characteristics, shelf life, storage requirements, device use, and warnings, 
precautions, and contraindications. 
7.7 Product Receipt and Tracking 
Parietene™ DS Composite Mesh will be shipped to each site upon Sponsor collection and approval of all 
required regulatory documentation and each site will document the quantity, lot number(s), serial 
number(s), expiration date(s), and any additional details upon receipt in the Product Accountability Log. 
7.8 Product Return 
Any unused Parietene™ DS Composite Mesh will be returned to Medtronic after the last subject enrolled 
at the site and it will be documented in the product accountability log. 

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7.9 Product Accountability 
Parietene™ DS Composite Mesh will be provided to each site upon Sponsor collection and approval of all 
required regulatory documentation. The Parietene™ DS Composite Mesh will be labeled “Exclusively for 
Clinical Investigations” and should be stored in a secure (locked) area at room temperature. Access 
should be limited to only authorized personnel listed on the Delegation of Authority log. Device 
accountability logs will be provided to the site. It is the site’s responsibility to document the receipt 
(maintain material shipment/return forms), disposition of the product (per subject use, including 
amount used, amount remaining, lot number, etc.), transfer (if applicable) and return of all unopened 
study devices. 
8. Study Site Requirements 
8.1 Investigator/Investigation Site Selection 
This study will be conducted by experienced surgeons in the field of hernia surgery, who are board 
certified/board eligible, qualified by education and training in accordance with US and hospital 
guidelines, education, and relevant experience appropriate to the use of the product and associated 
procedures. Investigator(s)/sites must have adequate time and resources to conduct the study 
throughout the duration of the study and have access to an adequate number of eligible subjects. 
Investigator(s)/sites must be able to comply with applicable Institutional Review Board and regulatory 
requirements. Investigator(s) must not be debarred, disqualified, or working under sanctions in 
applicable regions. Qualifications are verified through valid CV and current licensing and maintained 
with study documentation. 
The Investigator(s) and the associated clinical study staff will receive training on the management of the 
clinical study and the device according to the instructions for use. 
9. Selection of Subjects 
9.1 Study Population 
One hundred and twenty-five (125) male or female subjects, aged ≥18 years at the time of consent, who 
meet the eligibility criteria and are undergoing elective ventral hernia repair using Parietene™ DS 
Composite Mesh will be enrolled at a minimum of 4 sites in the US. To reduce bias, enrollment will not 
exceed 40 subjects per site. 

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9.2 Subject Enrollment 
After being informed of the nature of the study, the subject will provide written informed consent that 
has been approved by the sponsor and the appropriate IRB of the respective clinical site. A minimum of 
one hundred and twenty-five (125) subjects will be enrolled in the study at a minimum of 4 US sites with 
competitive enrollment not to exceed 40 subjects per site. 
A subject is considered enrolled in the study when: 
• 
it is confirmed that the ICF is signed, 
• 
they meet all pre-operative inclusion criteria, 
• 
they meet no pre- or intra-operative exclusion criteria, 
• 
they have received Parietene™ DS Composite Mesh intraoperatively. 
Adverse events will be collected starting at the time of skin incision and the subject must be followed for 
the full 24 months if the procedure was begun or completed with the study device. If ICF signature 
occurs more than 30 days before the procedure the subject is to be reconsented. No study procedures 
will be performed until informed consent form has been completed. 
The elective ventral hernia repair procedure will be performed per the intraperitoneal onlay mesh 
technique (IPOM) by open or laparoscopic approach. 
9.3 Inclusion Criteria 
Pre-Operative Inclusion Criteria 
1. Subject has provided informed consent 
2. Subject is ≥18 years of age (at the time of consent) 
3. Subject is undergoing elective ventral hernia repair (primary or incisional) with intraperitoneal 
mesh placement 
9.4 Exclusion Criteria 
Pre-Operative Exclusion Criteria 
1. BMI > 45 
2. Subject is undergoing emergency surgery 
3. Subject is pregnant or planning to become pregnant during study participation period 
4. Subject is unable or unwilling to comply with the study requirements or follow-up schedule 
5. Subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for 
the study or the subject has an estimated life expectancy of less than 6 months 
6. The subject has participated in another investigational drug or device research study within 30 

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days of enrollment 
7. Subject has a parastomal hernia 
Intra-operative Exclusion Criteria 
1. Subject’s hernia repair is in a contaminated or infected site as assessed by the Investigator 
(Exclude CDC wound class 2-4; See Section 17.3) 
2. Subject is undergoing “bridging” repair technique with the mesh placed in an “inlay” position 
3. Surgeon is unable to completely remove existing mesh from prior surgery 
4. Surgeon overlays 2 meshes 
5. Subject receives any mesh other than Parietene™ DS composite mesh 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10. Study Procedures 
10.1 Schedule of Events 
 
Procedure / Assessment 
Screening 
(Day -30 to 0) 
Operative 
(Day 0) 
 
Discharge 
Assessment 
1-Month 
(±14 days) 
Follow-up 
(Clinic / 
Remote 
Visit) 
3-Month 
(±14 days) 
Follow-up 
(Clinic / 
Remote 
Visit) 
12-Months 
(±30 days) 
Follow-up 
(Clinic / 
Remote 
Visit) 
24-Months 
(±30 days) 
Follow-up 
(Clinic / 
Remote 
Visit) 
  Can be combined 
Eligibility criteria 
X1 
X1 
Informed consent 
X2 
Subject demographics 
X 
Pregnancy status 
X1 
X1 
Medical and abdominal 
surgical history and 
relevant risk factors 
X 
Carolina Comfort 
Scale™ (Appendix B) 
X 
X 
X 
X 
Hernia defect description 
X 
Recurrence history if 
applicable 
X 
Date of surgery, Operative 
time 
X 
Anesthesia / ASA grade 
X 
Intraoperative wound 
contamination class 
X 
 Indication for ventral 
hernia surgery 
X 
Type of access, defect 
closure and Surgical 
technique approach 
X 
Mesh size, lot number, 
positioning, and 
fixation 
X 
Antibiotic prophylaxis 
X 
Area of mesh overlap 
X 
Surgeon satisfaction 
questionnaire 
X 
Adverse events  
X 
X 
X 
X 
X 
X 
Length of hospital stay 
X 
Hernia 
recurrence/reoperation 
X 
X 
X 
X 
Study exit 
X 
1. 
If Screening and Surgery occur on different days, these procedures should occur during Screening and be reconfirmed on the day of surgery. 
2. 
No study procedures will be performed until informed consent form has been completed. Subject should be re-consented if date of original consent is greater than 30 days. 

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10.2 Subject Screening (Day -30 to 0) 
A screening visit will be used to confirm pre-operative eligibility and consent subjects. Subjects will be 
consented prior to the start of any study specific procedures. Data collected as part as standard of care 
may be utilized to establish eligibility. The purpose and all aspects of the study will be explained to the 
subject. Subjects who agree to study participation must sign and personally date the sponsor and an 
IRB-approved informed consent form prior to participating in any study activities. 
Once the consent process has been completed and pre-operative eligibility has been confirmed, the 
following data will be collected. 
• 
Subject demographics (e.g., gender, age, ethnicity and race, weight, height) 
• 
Serum or urine pregnancy test for females of child-bearing potential unless subject is surgically 
sterile or postmenopausal for at least 2 years, as documented in the Medical Record 
• 
Medical and abdominal surgical history and relevant risk factors 
• 
Carolinas Comfort Scale™ QOL questionnaire – Pre-Operative assessment (Section 17.2: 
Appendix B) 
The screening visit will be performed within 30 days up to the day of the scheduled procedure and may 
be combined with the surgery procedure visit. 
10.3 Subject Consent  
Subjects will be consented prior to any study procedures are undertaken. Subjects will be provided with 
a description of the device and procedure; risks, benefits, and alternative procedures; length of 
participation required; and information regarding injury and confidentiality. Subjects will be informed 
that their participation in this study is voluntary and they may refuse to participate or discontinue from 
the study at any time. Subjects will be given the opportunity to ask the Investigator and/or designee(s) 
questions so that they are adequately informed about the research. The informed consent form must be 
signed and dated by subject and Investigator or authorized designee(s) at time of consent. The informed 
consent process will be documented in the source records and a copy of the consent will be provided to 
the subject. If the consent form is signed outside of 30-day screening window, a new consent must be 
signed/dated within 30 days prior to surgery. 
If new information becomes available that may affect a subject’s decision to continue to take part in the 
study, this information will be discussed with the subject by the investigator or designee and new 
consent will be obtained in writing. The informed consent process will be documented in the source 
records and a copy of the consent will be provided to the subject. 

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10.4 Operative (Day 0) 
The Study Investigator(s) should perform the elective surgical procedure according to the appropriate 
standard procedures and practices at the institution using Parietene™ DS Composite Mesh by Open or 
Laparoscopic approach with intra-peritoneal positioning. During the procedure, every effort should be 
made to close the defect and Parietene™ DS Composite Mesh used according to the instructions for use 
(Section 17.4 and 7.5). For study purpose, it is recommended a minimum of 5 cm mesh overlap beyond 
the edges of the defect and barbed sutures may be used for mesh fixation only if these sutures are 
claiming such indication. Additionally, the following procedures and assessments will be performed: 
• 
Eligibility Criteria (Intra-operative criteria) 
• 
Serum or urine pregnancy test for females of child-bearing potential unless the subject is 
surgically sterile or postmenopausal for at least 2 years (reconfirmed as necessary) 
• 
Hernia defect description 
• 
Recurrence history if applicable 
• 
Date of surgery, Operative time (from time of skin incision to closure) 
• 
Conditions of Anesthesia / ASA grade 
• 
Intraoperative wound contamination class (CDC classification, Section 17.3: Appendix C) 
• 
Indication for ventral hernia surgery 
• 
Type of access, defect closure and surgical technique approach 
• 
Mesh size, mesh shape, lot number, positioning, and type of fixation 
• 
Antibiotic prophylaxis 
• 
Area of mesh overlap 
• 
Adverse events assessment  
• 
Surgeon satisfaction questionnaire 
10.4.1 
Discharge Assessment 
On the day of discharge the following assessments will be made: 
• 
Adverse events assessment  
• 
Length of hospital stay 

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10.4.2 
1-Month Follow-up (+/- 14 Days) Visit 
One (1) month post-operative, assessments will take place by delegated study personnel via an on-site 
visit. Assessments will include: 
• 
Hernia recurrence/reoperation 
• 
Adverse events assessment 
• 
Carolinas Comfort Scale™ QOL questionnaire - Post-Operative assessment 
 (Section 17.2: Appendix B) 
10.4.3 
3-Month Follow-up (+/- 14 Days) Visit 
Three (3) months post-operative, the following assessment will take place during a subject visit: 
• 
Hernia recurrence/reoperation 
• 
Adverse events assessment  
10.4.4 
12-Month and 24-Month Follow-up (+/- 30 Days) Visit 
Twelve (12) and twenty-four (24) months post-operative, the following assessment will take place 
during a subject visit: 
• 
Hernia recurrence/reoperation 
• 
Adverse events assessment 
• 
Carolinas Comfort Scale™ QOL questionnaire- Post-Operative assessment 
(Section 17.2: Appendix B) 
If at the twenty-four (24) month post-operative visit, after three (3) attempts, the subject is unwilling 
or unable to be seen by the investigator, medical records from primary care physician may be used. In 
addition, the Carolinas Comfort Scale™ QOL questionnaire may be answered over the phone to study 
personnel. In the event of these occurrences, subjects will not be compensated.  
After the study has been completed no further study specific medical care will be provided and 
subjects will receive standard of care. 
10.5 Unscheduled Follow-up Visits 
In the event that a subject needs to be seen by the investigator for a complication outside of the study 
schedule of events, an unscheduled visit form must be completed. During any additional unscheduled 
visit(s) the following assessments will take place: 

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• 
Hernia recurrence/reoperation 
• 
Adverse events assessment 
10.6 Conducting Remote Subject Follow-up Visits 
When an in-person subject follow-up visit is unable to occur, alternative follow up may be utilized. 
Remote or phone follow-up, medical record review, or follow-up with other healthcare practitioner may 
be utilized for 1-month, 3-month, 12-month and 24-month visits.   
Clinic Electronic Medical Records (EMR) or medical records from primary care physicians may be used to 
assess hernia recurrence/reoperation and adverse events. Assessments will take place by delegated 
study personnel via remote follow-up visit(s).   
• 
Assessments will include:   
• 
Hernia recurrence/reoperation   
• 
Adverse events assessment  
• 
The Carolinas Comfort Scale™ QOL questionnaire (MDT17051PDS Clinical Investigation Protocol, 
Section 17.2: Appendix B) may be answered over the phone/remote to study personnel as 
requested at 1-month, 12-month and 24-month follow-up intervals, exempting 3-month follow-
up visit as per the Parietene™ DS Composite Mesh in Ventral Hernia Repair CIP v3.   
If hernia or hernia reoccurrence is suspected, the subject will be instructed to return to the clinic or 
hospital for diagnosis by the surgeon through clinical assessment. This should be done at the discretion 
of the Principal Investigator. 
Data collection from remote follow-up visits will be entered in the EMR and via Oracle Clinical Remote 
Data Capture (OC RDC).   
10.6.1 
Protocol Deviations and Remote Follow-up 
If a subject is unable to attend an in-person follow-up visit and a remote follow-up visit occurs, it is 
expected that there will be a protocol deviation (PD). Follow-up procedures, such as physical 
examination, may not be able to be recorded.   
For clinical protocol safety, the subjects should follow the general instruction of the Principal 
Investigator and hospital/clinic.  
The following guidelines should be followed:  
• 
In order to account for each deviation, all deviations need to be reported individually, according 
to the study protocol requirements.  

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• 
If any follow-up procedure is unable to be performed due to a remote visit due to COVID-19 
Pandemic, it should be documented in OC RDC as follows: 
o In the field “what was the reason for deviation?” please enter “COVID-19 impact.”  This 
is the acceptable rationale during the COVID 19 pandemic. 
10.6.2 
Subject Compensation and Remote Follow-up 
In the event of remote subject follow-up visits, subject may be compensated if such compensation is 
included in the institution’s Clinical Study Agreement. 
10.7 Randomization and Treatment Assignment 
No randomization will occur throughout the course of this study. 
10.7.1 
Blinding 
No blinding will occur throughout the course of this study. 
10.8 Assessment of Efficacy 
Hernia recurrence within 24 months post-operatively will be recorded in the eCRF and used to assess 
the efficacy of the Parietene™ DS Composite Mesh. 
10.9 Assessment of Safety 
All intra-operative and post-operative subject adverse events will be reported in the database. Adverse 
events will be reported to IRBs and regulatory authorities in accordance with the local IRB regulations 
and FDA regulations. 
10.10 Recording Data 
This study will utilize an electronic database and eCRFs. All data requested on the eCRFs are required. 
Study visits or measurements not collected and/or recorded will be considered deviations unless 
otherwise specified. The Principal Investigator or authorized designee(s) must ensure the accuracy and 
completeness of the recorded data and then provide his/her electronic signature on the eCRFs. Changes 
to data previously submitted to the sponsor will require a new electronic signature by the Investigator 
to acknowledge/approve the changes. 
10.11 Deviation Handling 
No changes to the protocol will be permitted by the Investigator(s). The investigator(s) must notify 
Medtronic and the reviewing IRB of any deviation from the Investigational Plan when specific to the 
protection of the life or physical well-being of a subject in an emergency per local IRB regulations. The 

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deviation will be recorded in the eCRFs and such notice must be given as soon as possible, but in no 
event later than 5 working days after the emergency has occurred. Except in such an emergency, prior 
written approval by Medtronic is required for changes in or deviations from the Plan. If these changes or 
deviations affect the scientific soundness of the Investigational Plan or the rights, safety, or welfare of 
human subjects the IRB will also be notified. All other deviations will be reported per the site’s IRB 
deviation policy. Should any deviations from the Investigational Plan occur, these will be reviewed by 
Medtronic for their clinical significance and compliance to the protocol. If the deviation is performed 
without written approval from all parties, the investigator may be terminated from the study. 
10.12 Subject Exit, Withdrawal or Discontinuation 
10.12.1 
Enrolled 
A subject is considered enrolled in the study when it is confirmed that the ICF is signed, subject meets all 
pre-operative inclusion criteria, subject meets no pre- or intra-operative exclusion criteria, and the 
subject has received Parietene™ DS composite intra-operatively. The subject must be followed for the 
full 24 months if the procedure was begun or completed with the study device. See section 8.2 for 
additional details. 
10.12.2 
Screen Failure 
10.12.2.1 
Prior to Surgery 
Subjects who provide study consent, but then are determined to be ineligible prior to the procedure due 
to Pre-Operative inclusion or exclusion criteria will be considered a “screen failure prior to surgery” and 
will not require additional study follow-up visits. The reason for the screening failure will be clearly 
recorded on the applicable eCRFs and subjects who are considered a Screen Fail prior to surgery will be 
replaced. 
10.12.2.2 
During Surgery 
Subjects who provide study consent and experience skin incision but then are determined to be 
ineligible during the procedure due to intra-operative exclusion criteria (i.e., Subject receives any mesh 
other than Parietene™ DS Composite Mesh or meet other exclusion criteria) will be considered “screen 
failed during surgery” and will be followed until discharge (no additional follow-up). Subjects who have 
not met eligibility and are considered a Screen Fail during surgery, will be replaced. 
10.12.3 
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. All data available through the time of the subject’s exit will be used for 
analysis.  

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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 
• 
Subject death 
• 
Subject did not meet inclusion/exclusion criteria  
• 
Subject was not implanted with a (investigational) device 
• 
Subject did not provide consent <or data use protection authorization> 
• 
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)  
If discontinuation is because of safety or lack of effectiveness, the subject may be asked to be followed 
for collecting safety data outside the clinical investigation. 
10.12.4 
Withdrawal 
The reason for study exit will be documented on the applicable eCRFs. In the event the subject 
withdraws consent during the study, the date of withdrawal will be documented. If the study 
Investigator(s) voluntarily removes a subject from further study participation, supporting 
documentation must be in place for the rationale and date of removal. Follow-up of subjects withdrawn 
will be determined by investigator(s). Withdrawn subjects will be not replaced. 
10.12.5 
Lost to Follow-up (LTFU) 
Subject (LTFU) should be avoided as much as possible, and investigators are urged to do their utmost 
best to maintain subject follow-up compliance.  
Subjects are not considered lost to follow-up until the end of the study, before the database is locked.  
As is the case before documenting a missed visit, the following should take place and be documented 
before considering them LTFU. 
• 
Three (3) phone calls should be made to the subject. Each attempt should be clearly 
documented in the source documents and the response or lack thereof should be captured. 
• 
If there is no response to the phone calls, then an official, certified letter should be written to 
the subject. A copy of the letter and return or delivery receipts should be retained in the 

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subject’s source documentation. 
• 
In case a subject can no longer be found, the monitor shall check the appropriateness of the 
site's attempts to contact the subject. 
Prior to final database lock, when all due diligence attempts to contact have been made, the subject is 
considered lost to follow-up. The Sponsor must be notified and the Exit eCRF must be completed. 
11. Risks and Benefits 
11.1 Potential Risks 
Surgeons participating in this study are experienced with the known risks related to standard of care for 
hernia repair procedures. Risks associated with the use of Parietene™ DS composite include, but are not 
necessarily limited to: seroma, hematoma, recurrence, adhesions, bowel obstruction, fistula formation, 
infection, inflammation, acute and chronic pain, extrusion/erosion and/or allergic reaction to the 
components of the device. 
The instructions for use (IFU) and training will guide surgeons on proper use of the device. Surgeons will 
undergo training on the device prior to participation in the study. 
As with any device, there is always a risk of a rare or previously unknown side effect developing from the 
treatment or use of the device. Overall, the residual risk for Parietene™ DS Composite Mesh was deemed 
acceptable. 
11.2 Potential Benefits 
The information obtained from this study will be used to confirm the safety and performance of 
Parietene™ DS Composite Mesh in ventral hernia repair. This information may lead to findings that may 
or may not result in a reduction of adverse events for future subjects. 
11.3 Risk Minimization 
Parietene™ DS Composite Mesh was 510(k) Cleared by the FDA (USA) in June 2017. Consequently, 
Parietene™ DS Composite Mesh presents a favorable risk/benefit ratio to the subject. The instructions 
for use in addition to surgeon training, will instruct surgeons on proper use of the device to mitigate risk. 
There are currently no known interactions between Parietene™ DS Composite Mesh and concurrent 
medical interventions. 
12. Adverse Events and Device Deficiencies  
All information will be collected throughout the study duration, starting at the time of signing the 
Informed Consent. Reporting of these events to Medtronic will be occur on an AE eCRF. Each event must 

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be reported separately. Documented pre-existing conditions will not be considered AEs unless the 
nature or severity of the condition has worsened. For AEs that require immediate reporting (Table 2), 
initial reporting may be done by phone, fax, or on the CRF completing as much information as possible. 
The completed AE eCRF must be submitted to Medtronic as soon as possible. Any indication/treatment 
associated with the treatment of an AE must be reported.  
12.1 Adverse Events  
Potential Adverse Events associated with the use of Parietene™ DS composite in ventral hernia repair 
could include but are not limited to; seroma, hematoma, recurrence, adhesions, bowel obstruction, 
fistula formation, infection, inflammation, acute and chronic pain, extrusion/erosion and/or allergic 
reaction to the components of the device. In regard to pain, the following definitions will be used for 
this study: 
• 
Acute pain (pain that resolves within three months of surgery) 
• 
Chronic pain (pain that lasts more than three months after surgery) 
For study purposes, the following occurrences are considered to be unavoidable adverse events as they 
are expected observations following surgical procedures (primarily associated with anesthesia) and will 
not be considered reportable AEs, as long as the event is not associated with significant sequelae, does 
not prolong hospitalization, and responds to standard medical therapy: 
• 
Post-Operative transient nausea determined to be procedure related within the first 24 post-
operative hours. 
• 
Post-Operative transient emesis determined to be procedure related within the first 24 post-
operative hours. 
• 
Post-Operative constipation determined to be procedure and/or medication related for the 
duration of medication administration for management of pain. 
• 
Post-Operative pain that the Investigator considers common and within normal limits for the 
procedure and is well-managed with medication. 
 All Adverse Events and Device Deficiencies will be collected and documented in the eCRF starting at the 
time of enrollment for all subjects, up to and including 24 months follow-up and monitored until 
resolved if possible. 
For Adverse Events that require immediate reporting initial reporting may be done by phone, fax, e-mail 
or on the eCRF, completing as much information as is available. The original fully completed Adverse 
Event eCRF must be submitted to Medtronic as soon as possible. In addition, Investigators are obligated 
to report Adverse Events in accordance with the requirements of their IRB.  

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12.2 Device Deficiency  
Device deficiencies (DD) information will be collected throughout the duration of the study and required 
to be reported to Medtronic. If there is an adverse event that results from a device deficiency, that 
specific event would be recorded on the appropriate Adverse Event eCRF and Device Deficiency eCRFs. If 
the device deficiency did not lead to an adverse event but could have led to a serious adverse device 
effect (i.e., if suitable action had not been taken, if intervention had been made, or if the circumstances 
had been less fortunate) it requires immediate reporting. Device deficiencies that did not lead to an AE 
should be reported on the Device Deficiency eCRF (one for each device deficiency).   
In the event of a device deficiency, the device should be returned to Medtronic for analysis, if possible. 
Instructions for returning the study device will be provided. Device deficiencies should also be 
documented in the subject’s medical record. 
12.3 Definitions and Classifications  
All definitions are provided in Table 1: Adverse Event and Device Deficiency Definitions.  
Table 1: Adverse Event and Device Deficiency Definitions  
Event Type  
Definition 
Adverse Event (AE)  
 
Any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device. 
 
NOTE 1: This definition includes events related to the investigational medical device 
and the procedures involved.  
NOTE 2: For users or other persons, this definition is restricted to events related to 
investigational medical devices.  
Serious Adverse Event 
(SAE)  
 
A serious adverse event (SAE) that has:  
a) led to death,  
b) led to a serious deterioration in the health of the subject, resulting in  
1) resulted in a life-threatening illness or injury, or  
2) resulted in a permanent impairment of a body structure or a body 
function, or 
3) in-patient or prolonged hospitalization, or  
4) medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function,  
c) led to fetal distress, fetal death or a congenital abnormality or birth defect.10,11  
 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required 
by the clinical investigational plan, without serious deterioration in health, is not 
considered a SAE.  
Adverse Device Effect 
(ADE)  
 
An Adverse Device Effect related to the use of an investigational medical device.  
 

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Table 1: Adverse Event and Device Deficiency Definitions  
Event Type  
Definition 
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, 
or any malfunction of the investigational medical device.10  
NOTE 2: : This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device 
Serious Adverse Device 
Effect (SADE)  
A Serious Adverse Device Effect is an adverse device effect that has resulted in any 
of the consequences characteristic of a serious adverse event  
Unavoidable Adverse 
Event  
An Unavoidable Adverse Event inherent to a surgical procedure that is expected to 
occur in all subjects for a projected duration according to the Investigator’s opinion.  
Device Deficiency  
Inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety, or performance.  
 
NOTE: Device deficiencies include malfunctions, use errors, and inadequate labeling.  
12.4 Evaluation and Documentation of Adverse Events and Device 
Deficiencies  
Investigators are required to evaluate and document in the subject’s medical records all adverse events 
and device deficiencies (per the definitions in Table 1: Adverse Event and Device Deficiency Definitions) 
observed in study subjects from the time they are enrolled until they are exited from the study.  
12.5 Adverse Event and Device Deficiency Classification 
All AEs and DDs will be reviewed by a Medtronic representative. AEs will be classified according to the 
definitions provided (Table 2: Adverse Event Classification Responsibilities).  
Upon receipt of an AE, 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 MedDRA for Regulatory Activities, to assign a MedDRA term for each AE based on 
the information provided by the investigator. 
AEs and DDs will be classified according to the standard definitions as outlined in the table below:  
 
 
 
 
 
 
 
 
 
 
 

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Table 2: Adverse Event Classification Responsibilities 
What is classified? 
Who classifies? 
Classification Parameters 
Relatedness 
Investigator 
Study Device, Study Procedure  
Sponsor 
Study Device, Study Procedure 
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 
Death Classification 
Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-Cardiac, Unknown 
Severity will be defined according to the following criteria: 
Mild 
Awareness of event, but easily tolerated 
Moderate 
Discomfort enough to cause some interference with activities of daily living (ADL) 
Severe 
Incapacitating, with an inability to perform ADL 
An AE can be classified as severe and not deemed an SAE. Similarly, an SAE is not automatically severe in 
nature. These assessments are made by the site Principal Investigator. 
12.5.1 
Adverse Event Relationship Classifications   
Causality assessments define the relationship between the use of the medical device (including the 
medical-surgical procedure) and the occurrence of each adverse event. The presence of confounding 
factors, such as concomitant medication/treatment, the natural history of the underlying disease, other 
concurrent illness or risk factors shall also be considered. 
Each AE will be classified according to five different levels of causality for procedure and device. The 
sponsor and the investigator(s) will use the following definitions to assess the relationship of the 
adverse event to the investigational medical device and procedures: 
Not related: relationship to the device or procedures can be excluded when: 
1. the event is not a known side effect of the product category the device belongs to or of similar 
devices and procedures 
2. the event has no temporal relationship with the use of the device or the procedures; 
3. the serious event does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible; 
4. the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or increase of the 
level of activation/exposure), do not impact on the serious event; 

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5. the event involves a body-site or an organ not expected to be affected by the device or 
procedure; 
6. the serious 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); 
7. the event does not depend on a false result given by the device used for diagnosis, when 
applicable; 
8. harms to the subject are not clearly due to use error; 
9. In order to establish the non-relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/procedures and the serious event. 
Unlikely: the relationship with the use of the device seems not relevant and/or the event can be 
reasonably explained by another cause, but additional information may be obtained. 
Possible: the relationship with the use of the device is weak but cannot be ruled out completely. 
Alternative causes are also possible (e.g., an underlying or concurrent illness/ clinical condition or/and 
an effect of another device, drug or treatment). Cases where relatedness cannot be assessed, or no 
information has been obtained should also be classified as possible. 
Probable: the relationship with the use of the device seems relevant and/or the event cannot be 
reasonably explained by another cause, but additional information may be obtained. 
Causal relationship: the serious event is associated with the device or with procedures beyond 
reasonable doubt when: 
1. the event is a known side effect of the product category the device 
belongs to or of similar devices and procedures; 
2. the event has a temporal relationship with device use/application or procedures; 
3. the event involves a body-site or organ that 
a. the device or procedures are applied to; 
b. the device or procedures have an effect on; 
4. the serious event follows a known response pattern to the medical device (if the response 
pattern is previously known); 
5. the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
6. 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; 
7. harm to the subject is due to error in use; 
8. the event depends on a false result given by the device used for diagnosis, when applicable; 

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9. In order to establish the relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the serious event. 
The Sponsor and the Investigator(s) will distinguish between the adverse events related to the device 
and those related to the procedures (any procedure specific to the clinical investigation). An adverse 
event can be related both to procedures and the device. Complications of procedures are considered 
not related if the said procedures would have been applied to the subjects also in the absence of device 
use/application. 
In some cases, the event may be not adequately assessed because information is insufficient or 
contradictory and/or the data cannot be verified or supplemented. The sponsor and the Investigator(s) 
will make the maximum effort to define and categorize the event and avoid these situations.  
12.6 Adverse Event and Device Deficiency Reporting 
Requirements  
Investigators are obligated to report applicable adverse events to the study sponsor and in accordance 
with reporting requirements of their IRB.  
Events will be reviewed by the sponsor to determine any reporting obligations to IRBs and regulatory 
authorities. 
SAEs need to be reported to the sponsor within 24 hours of becoming aware. 
Assessment of the occurrence of an AE will be based on changes in the subject’s physical examination, 
laboratory results and/or signs and symptoms. Adverse events will be monitored until a subject 
completes the study, or unless the Investigator determines the event is related to the device, in which 
case they will be monitored until resolution if possible. Medical care will be provided, as defined in the 
informed consent, for any AE related to study participation. Adverse events will be collected on an AE 
eCRF and applicable source documentation. To the extent possible, the event to be recorded and 
reported is the event diagnosis as opposed to event symptoms (e.g., fever, chills, nausea and vomiting in 
the presence of a clinically diagnosed infection is to be reported as infection only). For subjects who are 
screen failure during surgery (Section 10.12.2.2) AEs will be recorded at time of enrollment until 
discharge. For other subjects, AEs occurring at time of enrollment and up to and including 24 months 
follow-up will be recorded. 
The following should not be considered an AE: 
• 
A condition requiring a preplanned procedure unless the condition worsened since screening 
• 
A pre-existing condition found at the time of screening, unless the condition has worsened 
since enrollment. 
All responses to the above events that require treatment beyond the institution’s standard procedures 
must be reported. 

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All AEs observed during the course of this study, regardless of severity, seriousness, or relationship to 
the device and procedure will be recorded on the appropriate AE eCRF.  
12.7 Study Contact Information  
Questions regarding safety or medical procedures should be directed to Medtronic. All other questions 
including emergency contact for reporting serious adverse events and serious adverse device effects 
should be directed to Medtronic Surgical Innovations (Formerly MITG Surgical Innovations), Clinical 
Research. Sponsor contact information is subject to change and will be maintained in a document 
separate from the clinical investigation plan. Sponsor contact information available to sites upon 
request.  
12.8 Product Complaint Reporting 
Product complaint reporting and vigilance reporting are applicable, and AEs related to any market-
released device during the study must be reported. The reporting of product complaints is not part of 
the study and should be done in addition to the AE reporting requirements.  Refer to local regulations 
for reporting requirements.  
Product Complaint: Any written, electronic, or oral communication that alleges deficiencies related to 
the identity, quality, durability, reliability, safety, effectiveness, or performance of a medical device that 
has been placed on the market. 
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. 
• 
Any serious deterioration in the state of health, including: 
 
Life-threatening illness or injury 
 
Permanent impairment of a body function or permanent damage to a body 
structure 

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 
A condition necessitating medical or surgical intervention to prevent permanent 
impairment of a body function or permanent damage to a body structure 
13. Data Review Committees  
13.1 Independent Medical Monitor  
Medtronic will utilize an Independent Medical Monitor to provide an independent adjudication of pre- 
specified adverse events in support of protocol defined endpoint data. The Independent Medical 
Monitor will be a surgeon in the field of hernia surgery, who is board certified/board eligible, qualified 
by education and training, and relevant experience appropriate to the use of the product and associated 
procedures that is not affiliated with an investigative center. The Independent Medical Monitor will 
contribute to safety aspects of the clinical study and will review any potential adverse events collected 
related to the procedure/product, and all SAEs as determined by sponsors or sites. 
The Independent Medical Monitor will be blinded to the investigational sites. 
14.  Statistical Design and Methods 
14.1 Statistical Test Methods & Analysis Populations  
Statistical analysis consists mainly of a descriptive analysis, and will be performed on: 
• 
the Full Analysis Set (FAS, including any subject enrolled and receiving study device) 
representing the primary analysis population, 
• 
the Per Protocol Analysis Set [PPAS, a subset of the FAS of subjects who meet the primary 
endpoint (12-month assessment) and who did not deviate (major) from the protocol], as 
confirmatory analysis and, 
• 
the Safety Analysis Set (any subject with skin incision including those who are ‘screen failure 
during surgery’) for safety and efficacy analysis 
Continuous variables will be summarized using counts, means, standard deviations, medians, minimum 
and maximum. Categorical variables will be summarized using frequencies and percentages. 
Time to events analyses using Kaplan Meier estimates and curve will be performed for time to 
recurrence or to adverse event occurrence 
Changes to the planned statistical analysis as defined in the protocol will be documented in the 
statistical analysis plan and clinical study report. 
Statistical analysis will be performed using SAS version 9.4 and Minitab® Version 15.0. 

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For the purposes of study analysis and statistics adverse event will be defined as procedure related 
adverse events and adverse device effects. 
14.2 Interim Analysis  
Preliminary analysis will be conducted in the study when 30 enrolled subjects complete the 3-month 
follow-up time-point. The objective is to confirm safety of the product at 3 months. This 3-month time-
point is consistent with the wound healing period and the Parietene™ DS Composite Mesh film 
degradation profile (completely degraded by bulk hydrolysis in less than 15 weeks). This interim analysis 
is driven by regulatory needs, to support CE marking submission. 
Through analysis of clinical data available on a predicate device (Proceed™ surgical mesh) and similar 
Medtronic composite meshes (Parietene™ Composite Mesh, Parietex™ Composite Mesh) used in ventral 
hernia repair (primary and incisional) by open or laparoscopic approach assessed during short-term post- 
surgery report the following adverse event rates: 
- 
10.6% on the equivalent, Proceed™ surgical mesh used in laparoscopic ventral hernia repair at 
3- 6 weeks follow-up (9), 
- 
14.3% on Parietene™ Composite mesh used in laparoscopic ventral hernia repair at 10 weeks 
follow-up (range 6-25 weeks) (10), 
- 
To 25%, on Parietex™ Composite mesh used in laparoscopic and open ventral hernia repair after 
2 months follow-up with a population of 30 subjects (11), we obtain the following binomial 
probabilities to observe one or more event(s): 
Based on these studies, adverse event rates were estimated to range between 11% and 25% and used to 
generate binomial probabilities to observe at least 1 or 2 AEs with a sample size of 30 subjects as shown 
in the table below. 
N=30 subjects 
Hypothetic procedure related adverse event rate 
prob. to observe: 
11% 
12% 
14% 
17% 
20% 
25% 
≥ 1 AE 
97.0% 
97.8% 
98.9% 
99.6% 
99.9% 
100.0% 
≥ 2 AEs 
85.7% 
89.0% 
93.6% 
97.3% 
98.9% 
99.8% 
 
With an N=30 of enrolled and evaluable subjects at the time of interim analysis, and assuming an 11% 
adverse event rate, there is a 97% probability to observe at least 1 adverse event and an 85.7% 
probability to observe at least 2 adverse events. In addition, the probability to observe adverse events 
increases as the adverse event rate increases to a maximum of 100% and 99.8% for observation 1 and 2 
adverse events respectively at an adverse event rate of 25%. 
An additional interim analysis is planned to occur for completed 12-month follow-up visit data. 

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For the purpose of the interim analysis and in accordance with regulatory requirements all safety data 
will utilize MedDRA and are to be assessed using the potential risks identified and defined in Section 
12.3. The seriousness and relation of the adverse event to the device and procedure is assessed first by 
the Principal Investigator of the site, and if applicable by the external Medical Monitor or Internal 
Medtronic Safety Representative. Reconciliation is made between these assessments and the most 
conservative assessment will be used.  
14.3 Statistical Analysis Endpoints  
14.3.1 
Primary Endpoint 
Incidence of hernia recurrence within 12 months will be calculated on the FAS subjects who reach the 
12-month follow-up including any subject with hernia recurrence diagnosed within the 12-month period 
following surgery (even if the subject has withdrawn from the study before the 12-month assessment). 
The primary endpoint will be summarized using count, percentage, and the corresponding 95% confidence 
interval. Sub-group analyses on primary endpoints will be performed according to study needs and will be 
described in the Statistical Analysis Plan and the Clinical Study Report. 
14.3.2 
Secondary Endpoints  
• 
Incidence of ADEs intra-operatively will be calculated on the FAS subjects who reach the 
corresponding time point, including any subject experiencing hernia recurrence, AEs or ADE 
within the corresponding follow-up period. 
• 
Incidence of hernia recurrences will be calculated on the FAS subjects who reach the 
corresponding time point. 
• 
Time to hernia recurrence, as well as time to AE occurrence analyses will be run using Kaplan 
Meier estimate and curve. 
• 
Subject quality of life (QoL) questionnaires will be evaluated using the Carolinas Comfort 
Scale™ (Appendix B), and statistical analysis will follow the corresponding analysis guideline. 
• 
Length of hospital stay will be summarized using count, mean, standard deviation, median, 
minimum, and maximum. 
Subgroup analyses on secondary endpoints will be performed according to study needs and will be 
described in the statistical analysis plan and the clinical study report. 
14.4 Safety Assessment  
Most of the safety endpoints are part of secondary endpoints and method of evaluation are described 
above.  
Incidence of Adverse device effect, as well as SAEs, and SADEs will be calculated on the Full Analysis Set, 
Safety Analysis Set and Per protocol Analysis Set and summarized by counts and percentages. 

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Listings of AEs will be generated including event description, severity and seriousness, relation to 
procedure, relation to the device and outcome. 
In the case that a subject becomes pregnant postoperatively, a deviation will be submitted, and they will 
be followed for safety assessment. They will not be included in the primary or secondary endpoint 
analyses. 
14.5 Sample Size Determination  
Sample size has been determined based on an acceptable level of accuracy for the estimated rate of 
hernia recurrence at 12 months (primary endpoint). 
Previous studies of the predicate device (Proceed™ Surgical mesh) with similar study indications, 
population, and design (prospective study with a long-term follow-up with more than 100 subjects), 
have reported the incidence of recurrence at 12 months to range from 3.5% to 5.2%. (8, 9). 
95% confidence intervals obtained from incidence rates between 3.5% and 5.2% with N=100 subjects 
are shown below.  Precision of the recurrence rates range from ± 3.6% to ± 4.4% as the recurrence rate 
increases. 
 
Recurrence rate at 12-month (1 year) 
3.5% 
4.0% 
4.5% 
5.2% 
N 
100 
100 
100 
100 
95% CI 
[0.0 % - 7.1 %] 
[0.2% - 6.7%] 
[0.4% - 8.6%] 
[0.8% - 9.6%] 
accuracy (+/-) 
3.6% 
3.8% 
4.1% 
4.4% 
Anticipating an attrition rate of 20% at 12 months, 125 subjects will be enrolled for this study. 
14.6 Handling of Missing Data 
No data imputation will be performed for missing data unless otherwise noted in statistical analysis 
plan. All practical monitoring and follow-up steps will be taken to ensure complete and accurate data 
collection. 
15. Ethics 
15.1 Statement(s) of Compliance  
This clinical investigation will be conducted in accordance with the protocol, with the ethical principles 
that have their origin in the Declaration of Helsinki, Good Clinical Practice guideline and any regional or 
national regulations such as FDA regulations (US), as appropriate. All principles of the Declaration of 

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Helsinki have been implemented in this clinical study by means of the subject informed consent process, 
IRB approval, clinical study training, clinical study registration, publication policy. 
Ultimately, all study sites in all geographies will follow and comply with: 
•
21 CFR Part 11 (Electronic Records, Electronic Signatures)
•
21 CFR Part 50 (Protection of Human Subjects)
•
21 CFR Part 54 (Financial Disclosure by Clinical Investigators)
•
21 CFR Part 56 (IRBs)
•
21 CFR Part 803 (Medical Device Reporting)
•
The CTA
•
Procedures described within this CIP
•
Local EC Requirements
The clinical investigation will not begin until all necessary approvals/favorable opinions are obtained 
from the appropriate IRB. Should an IRB impose any additional requirements, they will be followed. 
Information regarding the study and study data will be made available via publication on 
clinicaltrials.gov. Additionally, the results of this study will be offered for publication at the conclusion of 
the study, if participating investigator(s) believe the data warrants publication in an appropriate journal. 
16.
Study Administration
16.1 Monitoring 
Site visits will be conducted by  authorized Medtronic representative(s) to qualify potential sites, 
conduct site initiation, ensure compliance, assess informed consent process, conduct interim monitoring 
visits to monitor study data, subjects’ medical records, eCRFs, device accountability, device use and 
storage, IRB submissions, regulatory binder in accordance with current protocol, ICH, GCPs and the 
respective local and national regulations and guidelines (if applicable) as well as close-out site activities. 
The Study Investigator(s) and the investigating site will permit authorized clinical research personnel 
from Medtronic or contracted by Medtronic to review completed eCRFs, IRB decisions, and Investigator 
and clinical site records at regular intervals throughout the study as well as permit study-related 
monitoring, audits, IRB review, and regulatory inspection(s) by providing direct access to source 
data/documents per the monitoring plan. Additionally, subject charts and clinical records will be 
requested and reviewed so that protocol adherence and source documentation can be verified. In 
instances where data protection regulations prohibit the direct examination of hospital records by the 

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study Sponsor or designee(s), the Investigator(s) will cooperate in a system of source data verification 
with the Sponsor. Monitoring may be performed with in person visits or remotely, when applicable. 
To ensure the rights, safety, and welfare of study subjects are being maintained, the monitor will 
maintain assurance that all study staff are trained on the study protocol and use of the study devices. If 
the monitor discovers that an investigator is not complying with the signed Investigator Agreement, the 
investigational plan, applicable laws, or any conditions of approval imposed by the reviewing IRB, the 
monitor will report to the Sponsor and take such steps necessary to promptly secure compliance. If 
compliance cannot be secured, device shipments to the investigator may be discontinued and the 
investigator’s participation in the investigation terminated. The monitor shall also require such an 
investigator to dispose of or return the device, unless this action would jeopardize the rights, safety, or 
welfare of a subject. 
16.2 Data Management  
Data review will be performed to identify possible data discrepancies. Manual and/or automatic queries 
will be created in the Oracle® Remote Data Capture (RDC) system and will be issued to the site for 
appropriate response. The site staff will be responsible for resolving all queries in the database. Adverse 
Events will be coded per Medical Dictionary for Regulatory Activities (MedDRA). 
This study will be using a 21 CFR Part 11 compliant electronic data capture system. All system level 
validation documentation is retained within the Medtronic Information Systems group. 
16.3 Direct Access to Source Data/Documents 
Investigator(s)/institution(s) will permit study-related monitoring, audits, IRB review, and regulatory 
inspection(s), and provide direct access to source data/documents as per local policies and regulations. 
16.4 Confidentiality  
All records identifying the subject will be kept confidential and, to the extent permitted by the 
applicable laws and/or regulations, will not be made publicly available. 
Subject names will be kept confidential. Only the site identification number and subject number will be 
recorded in the eCRFs, and if the subject name appears on any other document, it must be redacted. 
Study findings stored on a computer will be stored in accordance with local data protection laws. The 
subjects will be informed in writing that representatives of the sponsor, IRBs, or Regulatory Authorities 
may inspect their medical records to verify the information collected, and that all personal information 
made available for inspection will be handled in strictest confidence and in accordance with local data 
protection laws. Subjects will also be informed that information regarding the study that does not 
include subject identifiers will be posted on clinicaltrials.gov. 

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When the results of the study are published, the subject’s identity will remain confidential. The 
investigator will maintain a master subject list to enable subjects’ records to be identified. 
16.5 Liability 
Medtronic maintains appropriate clinical study liability insurance coverage as required under applicable 
laws and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a clinical study insurance statement/certificate will be provided to the IRB. 
16.6 Clinical Investigation Plan (CIP) / Protocol Amendments  
A CIP/Protocol amendment will be prepared when there are revisions that are significant changes or 
corrections, or modifications that impact subject safety, ethical conduct, data integrity or study design. 
CIP/Protocol amendments must undergo review and approval by the sponsor, IRB, and any appropriate 
regulatory authority, and will be logged in the document version history (Section 18). IRB approval, 
regulatory authority approval (if applicable), site training and a new Acknowledgement form will be 
signed and returned before any new enrollment takes place. 
16.7 Record Retention  
The investigator(s) and the sponsor will maintain the records of the study including all pertinent 
correspondence, the study protocol with any/all amendments, all correspondence with and approval 
from the IRB, the Investigator Agreement, device accountability records, individual subject records, and 
signed informed consent forms. Subject files, other source data and essential documentation kept in the 
Investigator study files, must be kept for a period of no less than 24 months after the latter of the 
following two dates: the date on which this investigation is terminated or completed. Records may need 
to be maintained by the Principal Investigator for a longer duration if national regulations require or if 
agreed to in writing with Medtronic. All data and documents should be made available if requested by 
relevant authorities. 
16.8 Publication and Use of Information 
The Medtronic Publication and Authorship Policy is aligned with the International Committee of Medical 
Journal Editors (ICMJE) recommendations (www.icmje.org). Medtronic will seek to publish, in 
appropriate peer-reviewed journals and scientific conferences, results of clinical studies where human 
subjects are involved, regardless of outcome. While study results are owned by Medtronic, all data on 
which a publication is based will be made available to all authors as required for their participation in 
the publication process. Furthermore, data may be published or used by study investigator(s) provided 
that such publication or use is in accordance with this protocol, the Medtronic Publication and 
Authorship Policy, and the Clinical Investigation Agreement. Investigator(s) must submit a copy of all 
manuscripts and/or abstracts to Medtronic for review and comment 30 days prior to planned 
submission. Medtronic acknowledges that its right to review and comment shall relate solely to the 

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proprietary, licensing, and/or confidential rights Medtronic may have in such proposed publication, 
rather than whether such results and/or opinions are favorable to Medtronic. 
The publication of post-hoc analyses, regional results, or single-center experiences based on multicenter 
clinical studies should not precede that of the primary multicenter publication, and should cite the 
primary publication whenever possible, as required by specific journal and scientific meeting guidelines. 
Medtronic involvement in a publication (e.g., funding of the study; sponsor of the study; collection, 
analysis, and interpretation of data; professional writing assistance) must be disclosed according to 
journal-specific policies, submission requirements, and prevailing editorial standards, in addition to 
those specified by International Committee of Medical Journal Editors. Authors must ensure that an 
acknowledgement/disclosure statement is included in the body of the manuscript for Medtronic to 
review for accuracy. All authors must also disclose financial or personal affiliations that could be 
considered conflicts of interest as per journal/conference requirements. 
To enable health care providers, payers, and subjects’ access to the wealth of Medtronic’s research, 
Medtronic will report its scientific data in accordance with the principles outlined in the Guidance 
Document on Registration and Reporting Results of Company-Sponsored Clinical Trials under FDAAA 
2007 (Title VIII). 
16.9 Suspension or Early Termination 
Medtronic or appropriate regulatory authorities reserve the right to suspend or discontinue the study at 
any stage, with 60 days written notice to all investigators, all institutions, all reviewing IRBs, all subjects 
and subjects’ personal physicians and any applicable regulatory agencies. Similarly, investigator(s) may 
withdraw from the study at any time, subject to providing written notification to Medtronic 60 days 
prior to the date they intend to withdraw. However, Medtronic and investigator(s) will be bound by 
their obligation to complete the follow-up of subjects already enrolled in the study. The subjects must 
be followed according to the clinical protocol, and information obtained during subject follow-up shall 
be reported to Medtronic on the appropriate eCRF. Either Medtronic or the investigator may also 
terminate the agreement if the other breaches the terms or conditions of the agreement and fails to 
address the breach within 30 days after receiving written notice. Furthermore, the institution may 
immediately terminate the study for concerns related to Study Subject health and safety. 
 
 
 
 
 

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17. References 
1. 
Muysoms F, Campanelli G, Champault GG, DeBeaux AC, Dietz UA, Jeekel J, et al. EuraHS: the 
development of an international online platform for registration and outcome measurement of ventral 
abdominal wall hernia repair. Hernia. 2012;16(3):239-50. doi: 10.1007/s10029-012-0912-7. PubMed 
PMID: 22527930; PubMed Central PMCID: PMCPMC3360853. 
2. 
Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, et al. European 
Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009;13(4):343- 
403. doi: 10.1007/s10029-009-0529-7. PubMed PMID: 19636493; PubMed Central PMCID: 
PMCPMC2719730. 
3. 
Rutkow IM. Demographic and socioeconomic aspects of hernia repair in the United States in 
2003. Surg Clin North Am. 2003;83(5):1045-51, v-vi. doi: 10.1016/S0039-6109(03)00132-4. PubMed 
PMID: 14533902. 
4. 
Awaiz A, Rahman F, Hossain MB, Yunus RM, Khan S, Memon B, et al. Meta-analysis and 
systematic review of laparoscopic versus open mesh repair for elective incisional hernia. Hernia. 
2015;19(3):449-63. doi: 10.1007/s10029-015-1351-z. PubMed PMID: 25650284. 
5. 
Nachiappan S, Markar S, Karthikesalingam A, Ziprin P, Faiz O. Prophylactic mesh placement in 
high-risk patients undergoing elective laparotomy: a systematic review. World J Surg. 2013;37(8):1861- 
71. doi: 10.1007/s00268-013-2046-1. PubMed PMID: 23584462. 
6. 
Ventral Hernia Working G, Breuing K, Butler CE, Ferzoco S, Franz M, Hultman CS, et al. 
Incisional ventral hernias: review of the literature and recommendations regarding the grading and 
technique of repair. Surgery. 2010;148(3):544-58. doi: 10.1016/j.surg.2010.01.008. PubMed PMID: 
20304452. 
7. 
Jacob B, Ramshoaw B. The SAGES Manual of Hernia Repair. 2013;Springer doi: 10.1007/978-1- 
4614-4824-2 
8. 
Berrevoet F, Fierens K, De Gols J, Navez B, Van Bastelaere W, Meir E, et al. Multicentric 
observational cohort study evaluating a composite mesh with incorporated oxidized regenerated 
cellulose in laparoscopic ventral hernia repair. Hernia. 2009;13(1):23-7. doi: 10.1007/s10029-008-0418- 
5. PubMed PMID: 18682886. 
9. 
Berrevoet F, Tollens T, Berwouts L, Bertrand C, Muysoms F, De Gols J, et al. A belgian 
multicenter prospective observational cohort study shows safe and efficient use of a composite mesh 
with incorporated oxidized regenerated cellulose in laparoscopic ventral hernia repair. Acta Chir Belg. 
2014;114(4):233-8. PubMed PMID: 26021417. 
10. 
Beldi G, Ipaktchi R, Wagner M, Gloor B, Candinas D. Laparoscopic ventral hernia repair is safe 
and cost effective. Surg Endosc. 2006;20(1):92-5. doi: 10.1007/s00464-005-0442-9. PubMed PMID: 
16333538. 
11. 
Balique JG, Benchetrit S, Bouillot JL, Flament JB, Gouillat C, Jarsaillon P, et al. Intraperitoneal 
treatment of incisional and umbilical hernias using an innovative composite mesh: four-year results of a 
prospective multicenter clinical trial. Hernia. 2005;9(1):68-74. doi: 10.1007/s10029-004-0300-z. PubMed 
PMID: 15578245. 

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18. Appendices 
18.1 APPENDIX A: List of Investigators and Institutions  
Investigational Site information including addresses, contact information, Principal Investigators, their 
respective IRBs will be retained in a separate document from the body of the clinical investigation plan 
document. This will be provided to investigational sites and updated as necessary. 
 
 

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18.2 APPENDIX B: Carolinas Comfort Scale™ 
 

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18.3 APPENDIX C: Centers for Disease Control (CDC) Wound Class 
 
CDC Wound Class 
(January 2017) 
Definition: 
1 
Clean: An uninfected operative wound in which no inflammation is 
encountered and the respiratory, alimentary, genital, or uninfected urinary 
tracts are not entered. In addition, clean wounds are primarily closed and, if 
necessary, drained with closed drainage. Operative incisional wounds that 
follow nonpenetrating (blunt) trauma should be included in this category if they 
meet the criteria. 
2 
Clean-Contaminated: Operative wounds in which the respiratory, alimentary, 
genital, or urinary tracts are entered under controlled conditions and without 
unusual contamination. Specifically, operations involving the biliary tract, 
appendix, vagina, and oropharynx are included in this category, provided no 
evidence of infection or major break in technique is encountered. 
3 
Contaminated: Open, fresh, accidental wounds. In addition, operations with 
major breaks in sterile technique (e.g., open cardiac massage) or gross spillage 
from the gastrointestinal tract, and incisions in which acute, nonpurulent 
inflammation is encountered including necrotic tissue without evidence of 
purulent drainage (e.g., dry gangrene) are included in this category. 
4 
Dirty or Infected: Includes old traumatic wounds with retained devitalized 
tissue and those that involve existing clinical infection or perforated viscera. 
This definition suggests that the organisms causing postoperative infection 
were present in the operative field before the operation. 
 
 
 
 
 
 
 
 
 
 
 
 

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18.4 APPENDIX D: Parietene™ DS Composite Mesh Instructions for Use 

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19. Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
Not Applicable, New Document 
Nicholas Paquette 
Senior Medical Writer 
2.0 
Amendment: 
-Cover page, header and section 1: 
Administrative change: updated 
document version number and date 
-Section3 and section 8.4: Exclusion 
criterion deleted: Procedure is a 
robotically assisted laparoscopic repair 
-Section 11.3: Administrative change: 
Updated study contact of Medical and 
Clinical Affairs representatives 
-Section 17.2: Administrative change: 
numbering of the questions of the Carolina 
Comfort scale pre-operative and post- 
operative assessments has been updated to 
correct the typo in the previous version of 
the CIP 
-Section 7.5.1: added “If barbed sutures are 
used for fixation, these sutures must have 
the specific indication for mesh fixation.” 
-Section 9.1.3: added: “and barbed 
sutures may be used for mesh fixation 
only if these sutures are claiming such 
indication” 
Marion Blanc 
Sr. Clinical Research Specialist 
3.0 
-Section 8.2: deleted: “No robotic 
procedures will be included as part of this 
study.” 
Marion Blanc 
Sr. Clinical Research Specialist 
4.0 
-Section 2: Adjusted glossary, removed 
Safety definitions as they are defined in the 
AE section of CIP, removed USADE/UADE 
as they are not required to be reported in 
post-market studies 
 
Alyssa Sutch 
Sr. Clinical Research Specialist 

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-Section 6.3: Clarified Steering Committee 
will only be comprised of site investigators 
 
-Section 10.6: Included verbiage allowing 
follow-up visits to be conducted remotely  
 
-Section 10.12.2.3: Added clarifying 
verbiage regarding Study Exit Visit 
 
-Section 10.12.2.5: Attempts made to 
contact patients that are considered LTFU 
will be monitored  
 
-Section 10.4.4: Clarified sites do not need 
prior written approval from Medtronic to 
complete a review of medical records 
should the patient be unwilling or unable to 
be seen by the investigator at the 12-
month or 24-month follow-up visit 
-Section 12.1: Added table with Adverse 
Event Definitions  
 
-Section 12.3.1: Added clarifying verbiage 
regarding Device Deficiencies  
 
-Section 12.3: Updated Study Contact 
Information 
 
-Section 12.5: Added table that discusses 
Adverse Event Classification 
Responsibilities 
 
-Section 13.1: Safety Committee is not 
applicable for PPDS study 
 
-Section 15.1: Stated regulatory regulations  
-Section 18.2: Added Carolinas Comfort 
Scale  
-Minor administrative changes throughout