Value Analysis Committee Product Information Kit

GORE® SYNECOR GORE® SYNECOR Intraperitoneal Biomaterial Preperitoneal Biomaterial

Value analysis committee product information kit

GORE® SYNECOR Biomaterial

Table of contents

Product overview Key considerations 1 .1 Applications 1 . 3 Permanent strength 1 . 4 Rapid cell migration and vascularization 1 . 5 Effect of pore size 1.5 Ingrowth 1.6 Fibrous tissue ingrowth 1 . 7 Rapid vascularity 1 . 8 Contraction 1 .8 Adhesions 1.9 Bacterial adherence 1 . 9 Handling 1.10

Product use recommendations Product use recommendations 2 . 1 Product replacement 2 . 2

Value analysis Overview 3 . 1 Economic 3 . 2 Pre-clinical data 3 . 3 Clinical data 3 . 4 Societal impact 3 .5

Materials management information Product configurations and sizing 4 .1 Product specifications 4 .1 Material composition 4.1 Coding and reimbursement 4 . 1 FDA clearance 4 .2 Instructions for use 4 .6

References 5 .1 Product overview

GORE® SYNECOR Biomaterial

Product overview

GORE® SYNECOR Biomaterial is the solution for delivering rapid vascularity with permanent strength. The product is a cost-effective, easy-to-use solutions for open, laparoscopic and robotic cases that combines:

• Rapid vascularity and ingrowth • Durable, single-stage repair

GORE® SYNECOR Biomaterial was designed with one purpose — Successful outcomes that provide value for:

Patients — A single surgery with faster recovery and fewer complications, versus a staged repair requiring multiple surgeries. Surgeons — A single-stage, durable repair in complex cases. Hospitals — Positive clinical outcomes with low cost of use. Payers — An efficient solution in complex cases, with an effective single procedure.

The key considerations for your value analysis include: 1. The products GORE® SYNECOR Biomaterial is a cost-effective, easy-to-use hernia repair solution for open, laparoscopic and robotic cases. It is a unique hybrid combining permanent strength with a tissue-building scaffold. Construction features include: • Poly(glycolide:trimethylene carbonate) copolymer (PGA:TMC) web scaffold — A tissue-building scaffold for rapid vascularity and ingrowth. • Latest generation macroporous knit of dense, monofilament PTFE fiber — May reduce risk of bacteria residing within the knit and provide optimum strength for a durable, single-stage repair. • A non-porous PGA:TMC film (intraperitoneal device only) — Minimizes tissue attachment to the material on the visceral side.

2. Those who benefit • General surgeons • Plastic surgeons • Trauma surgeons

3. The financial impact • Low cost of use versus biologic products of similar size, which are not intended for bridging and may require additional surgery.1,2 • Low cost of use compared to lightweight and mid-weight meshes that have clinical literature case studies demonstrating failure due to inadequate strength in similar indications.3–5

4. Impact on patient outcomes A single surgery with faster recovery and fewer complications, versus a staged repair requiring multiple surgeries.

1.1

GORE® SYNECOR Biomaterial

Product overview

GORE® SYNECOR Intraperitoneal Biomaterial is a unique combination of a macroporous knit of dense, monofilament PTFE fibers, a bioabsorbable copolymer web scaffold comprised of PGA:TMC on the parietal surface and a PGA:TMC non-porous film on the visceral surface. GORE® SYNECOR Intraperitoneal Biomaterial combines long-term strength with rapid tissue ingrowth and vascularization, providing a single-stage, durable repair in complex cases.

Gore 3D PGA:TMC web scaffold

Macroporous PTFE knit

Non-porous PGA:TMC film

• Gore 3D PGA:TMC web scaffold facilitates cell infiltration and tissue generation. • The latest generation macroporous knit of dense, monofilament PTFE fiber by Gore may reduce the risk of bacteria residing within the knit. • Non-porous PGA:TMC film minimizes visceral attachment to the material.

GORE® SYNECOR Preperitoneal Biomaterial is a unique combination of a macroporous knit of dense, monofilament PTFE fibers embedded between two Gore 3D PGA:TMC web scaffolds. GORE® SYNECOR Preperitoneal Biomaterial combines long- term strength, with rapid tissue ingrowth and vascularization, providing a single-stage, durable repair in complex cases.

Gore 3D PGA:TMC web scaffold Macroporous PTFE Knit Gore 3D PGA:TMC web scaffold

1.2

GORE® SYNECOR Biomaterial

Product overview

• Favorable for high risk wounds and challenging hernia repairs

• Less foreign material • Appropriate for bridging • Potentially lower inflammation • Long-term durability

Applications GORE® SYNECOR Intraperitoneal Biomaterial is intended for use in the repair of hernias, as well as abdominal wall or thoracic wall soft tissue deficiencies, that may require the addition of nonabsorbable reinforcing or bridging material. The GORE® SYNECOR Preperitoneal Biomaterial is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of a non-absorbable reinforcing or bridging material. These materials are appropriate for use in laparoscopic, open or robotic procedures.

Monofilament PTFE knit The treatment of ventral hernias with prosthetic devices has reduced recurrence rates but has led to questions concerning infection. Open hernia repair has been associated with infection rates from three to 18 percent.6 Laparoscopic ventral hernia repair has been associated with lower incidence of infection.6 The PTFE knit is designed with a fiber diameter similar to lightweight mesh but with the strength of a heavyweight mesh. Thus, the PTFE knit can maintain the surface area desired in lightweight materials but not sacrifice strength, as happens with polypropylene knits. The PTFE knit is designed from a dense, monofilament fiber, similar to polypropylene fibers. The macroporous knit of dense, monofilament PTFE fiber in GORE® SYNECOR Biomaterial may reduce the risk of bacterial adherence7, and along with increased vascularity8 may aid in the overall treatability of the device to minimize the need for removal if postoperative infection were to occur.

GORE® SYNECOR Biomaterial: Macroporous knit of dense Polypropylene knit monofilament PTFE fiber 1.3

GORE® SYNECOR Biomaterial

Product overview

Permanent strength for high BMIs, multiple co-morbidities and complex repairs GORE® SYNECOR Biomaterials are easy to handle, yet strong and compliant. Strength is an obvious concern when performing a structural repair, such as bridging a fascial defect in ventral hernia repair. This has become critical as patient body mass indices (BMIs) continue to increase. A permanent material, such as PTFE, must be able to maintain it’s integrity over the life of the patient, without degradation or loss in strength. The macroporous, monofilament PTFE knit provides permanent strength when bridging a hernia or soft tissue defect. Testing has shown the PTFE within GORE® SYNECOR Biomaterial to have a burst strength over 500 N providing strength for large defects or BMIs (Data on file 2016; .W L. Gore & Associates, Inc; Flagstaff, AZ).

High strength and optimal porosity * Literature suggests the strength requirement for bridging ventral hernia repair has an abdominal wall surface tension of 32 N / cm.9,10 A calculation is used to convert the 32 N / cm into a load of 255 N, which is measured using the international standard ball burst test method for material strength.11

700

GORE® SYNECOR Biomaterial The macroporous knit of dense, monofilament PTFE fibers provide optimum permanent strength ) 580 1.59 N mm for a dura ble, single-stage repair th (N Equivalent 47.8 N / cm ng ETHICON ULTRAPRO® (or 381 N) line10 Partially Absorbable Lightweight Mesh Potential tensile strength

ce needed for obese patients en rst stre

rr Equivalent 32 N / cm bu cu

(or 255 N) line ll BD® BARD® Soft Mesh MEDTRONIC SYMBOTEX

Ba Composite Mesh

sk of re

ri MEDTRONIC PARIETEX Optimized Composite (PCOx) Mesh ducing

Re Improving tissue response 0 0 3 Minimum pore size (mm)

• Strength measurement for GORE® SYNECOR Biomaterial is for knit component only; other product measurements conducted on full construct out of the box. • Strength measurement for composite mesh products may be lower, once respective bioabsorbable components are degraded. • Studies have shown that increasing pore size from medium to very large improved mechanical strength of tissue ingrowth12 and reduced any scar plate formation.13

* Data on file 2016; .W L. Gore & Associates, Inc; Flagstaff, AZ.

BD and BARD are trademarks of Becton, Dickinson and Company. ETHICON and ULTRAPRO are trademarks of Ethicon, Inc. MEDTRONIC, PARIETEX and SYMBOTEX are trademarks of Medtronic, Inc. 1.4

GORE® SYNECOR Biomaterial

Product overview

Rapid cell migration and vascularization Our bioabsorbable web scaffold supports the rapid development of quality tissue without the risks associated with biologics. The web component of GORE® SYNECOR Biomaterial is designed to break down primarily by hydrolysis, and provides uniformity and consistency. Within one to two weeks, the patient’s own cells migrate into the scaffold and begin generating vascularized soft tissue.14 Gradually, over approximately six to seven months, the web component is gradually absorbed by the body and replaced with the patient’s own favorable Type I collagen.* • Gore 3D PGA:TMC web scaffold facilitates cell infiltration and tissue generation.* • Non-porous PGA:TMC film minimizes visceral attachment to the material (intraperitoneal device only).*

Vascularity within Gore 3D PGA:TMC web scaffold increases over time15 40 d 30 Within one to two weeks, cells migrate into the Gore 20 3D PGA:TMC web scaffold and begin generating vascularized soft tissue

ssel count per fiel 10 Ve

0 3714 30 Days

Gore 3D PGA:TMC web scaffold replaced by tissue†,16 100 Gore 3D PGA:TMC web scaffold Collagen 80

20 Percent volume of defect 0 Day of implant 3 months‡ 6 months‡

* Data on file 2015; .W L. Gore & Associates, Inc; Flagstaff, AZ † The data in this graph is from GORE® BIO-A® Hernia Plug. ‡ Cells and blood vessels make up remaining volume. 1.5

GORE® SYNECOR Biomaterial

Product overview

Tissue ingrowth The combination of the Gore 3D PGA:TMC web scaffold and the macroporous PTFE knit allows for rapid cellular ingrowth and appropriate tissue integration without negatively affecting abdominal wall compliance typically associated with heavyweight polypropylene meshes.17 Studies of GORE® SYNECOR Intraperitoneal Biomaterial demonstrated that at 30 days, a neoperitoneal layer formed on the surface of the film and tissue ingrowth was present throughout the device with various densities around the knit fibers and within the web. The ingrowth was vascularized, organized and filled the macropores. (Data on file 2015; .W L. Gore & Associates, Inc; Flagstaff, AZ).

• Nonporous = capsule • 5 and 60 μm pores = vascularized tissue surrounding implant • 700 μm pores = “pseudocapsules” around nodules

Small blood vessels near the implant-tissue interface Solid nodules of the PVA

Typical tissue forming around the polyvinyl alcohol (PVA) implants. The implant is facing up from the bottom and the surrounding tissue is extending down from the top of each micrograph. Small blood vessels near the implant- tissue interface are indicated by small yellow arrows. Solid nodules of the PVA are indicated by large red arrowheads (original magnification x100). Note the dense tissue structure and relative avascularity of the (a) PVA-skin capsule. By contrast, the tissue response to the porous (b) PVA-5, and (c) PVA-60 implants is highly vascular, as noted by the abundance of small vessels, and comprises a less dense, more randomly oriented fibrous tissue structure. Note the pseudocapsules that form around each nodule of solid PVA in between the pores within the (d) PVA-700 implant.

Figure 1.

The extent of ingrowth achieved for any device is influenced by the size of the pores within the scaffold. While very small pores may inhibit tissue ingrowth, larger pores encourage the ingrowth of new tissue18 (Figure 1). The two layers of Gore 3D PGA:TMC web scaffold, which serve as the tissue-building scaffold in GORE® SYNECOR Preperitoneal Biomaterial, provides optimal porosity for rapid cellular infiltration and vascularization(Figure 2). These two web layers, on either side of the knit, form interconnected pores that are similar in structure to the collagen fiber network(Figure 3).

Engineering tissue response with material structure The PTFE knit layer of GORE® SYNECOR Biomaterial is a macroporous construct of large pores; average pore size is 1.59 mm (Figure 2). The web layer forms interconnected pores that are similar in structure to a collagen fiber network(Figure 3).

The effect of pore size 18,19

1 mm Tissue ingrowth device (“Macroporous”)

100 µm Gore 3D PGA:TMC web scaffold OPTIMAL PORE SIZE RANGE: Tissue ingrowth and tissue

generating /angiogenic device with optimal porosity Gore 3D PGA:TMC web scaffold for cellular infiltration and vascularization 10 µm

1 µm

Tissue ingrowth barrier device (“Microporous”) 0.1 µm Collagen gel Figure 2. Figure 3. 1.6

GORE® SYNECOR Biomaterial

Fibrous tissue ingrowth The combination of the Gore 3D PGA:TMC web scaffold with the macroporous PTFE knit in GORE® SYNECOR Biomaterial allows for rapid cellular ingrowth and appropriate tissue integration. Studies demonstrated that at 30 days, bioabsorption of the Gore 3D PGA:TMC web scaffold was evident within the GORE® SYNECOR Intraperitoneal Biomaterial (Figure 1),* and tissue ingrowth was present throughout the GORE® SYNECOR Preperitoneal Biomaterial, around the knit fibers and within the web Figure( 2).* The ingrowth was vascularized, organized and filled the macropores.

GORE® SYNECOR lntraperitoneal Biomaterial results • Organized fibrous tissue ingrowth at 180 days.* • Minimal encapsulation at 180 days.* GORE® SYNECOR Intraperitoneal Biomaterial GORE® SYNECOR Intraperitoneal Biomaterial 31 days 31 180 days

HE polarized 4x Figure 1. HE polarized 10x At 31 days, the 3 layers of the device are evident. The PGA:TMC film At 180 days, the Gore 3D PGA:TMC web scaffold is absorbed and there is (yellow) has begun to bioabsorb with fragmentation visible. The Gore organized tissue ingrowth with minimal tissue encapsulation of the PTFE knit. 3D PGA:TMC web scaffold layer (orange) shows signs of bioabsorption Overall the tissue response and fibrous tissue ingrowth was similar between with aggregation of web fibers. The PTFE knit fibers are visible (blue).* GORE® SYNECOR lntraperitoneal Biomaterial and a lightweight polypropylene.*

GORE® SYNECOR Preperitoneal Biomaterial results • Organized to densely organized fibrous tissue ingrowth at 180 days.* GORE® SYNECOR Preperitoneal Biomaterial GORE® SYNECOR Preperitoneal Biomaterial 30 days 30

HE polarized Figure 2. This section shows the GORE® SYNECOR Preperitoneal Biomaterial device (Web: black arrows, Fibers: F) filled completely with collagen, At 30 days, the Gore 3D PGA:TMC web layers (orange) shows some vessels (red arrows) and cells. 10x. HE. 30 days.* evidence of bioabsorption with aggregation of web fibers, the PTFE knit fibers are visible (blue).* Overall, this combination results in cellular migration and vascularization, which can facilitate healing after a hernia repair.

* Data on file 2015; .W L. Gore & Associates, Inc; Flagstaff, AZ. 1.7

GORE® SYNECOR Biomaterial

Product overview

Rapid vascularity Vascularity is an important assessment to be made during the acute healing process of implanted mesh materials, especially in complex abdominal wall repairs. In addition, there is even more importance in evaluating the presence of blood vessels throughout the device structure in the immediate postoperative time period. Assessing vascularity via microcomputed tomography (MicroCT), it was shown that as early as seven days post-implant, numerous newly formed blood vessels were observed both around and within the GORE® SYNECOR Biomaterials.14

Arrows indicate area where blood vessels are penetrating through the PTFE knit of GORE® SYNECOR Intraperitoneal Biomaterial at seven days post-implantation.

Minimal contraction All biomaterials, including polypropylene, polyester and PTFE, will contract to some degree after implantation due to the activity of myofibroblasts during wound healing. Animal studies show GORE® SYNECOR Biomaterials have minimal contraction at one and six months.

Device Days in-life Change in area GORE® SYNECOR Preperitoneal Biomaterial* 30 +15.7% 179 0.0% GORE® SYNECOR Intraperitoneal Biomaterial* 31 -5.1% 180 -6.6%

* Data on file 2015; .W L. Gore & Associates, Inc; Flagstaff, AZ. 1.8

GORE® SYNECOR Biomaterial

Product overview

Minimize visceral adhesion formation Typical neoperitonealization is thought to occur within five to eight days20 and during this time, the film surface remains intact providing a uniform surface for cellular deposition. The nonporous PGA:TMC film is designed to limit cellular penetration, which serves to minimize visceral adhesion formation to the material. Animal studies have shown no mid- substance adhesions to the material at both 30 and 180 days (Data on file 2015; .W L. Gore & Associates, Inc; Flagstaff, AZ).

Bacterial adherence7 Bacterial adherence was examined among various materials, including, the PTFE knit of GORE® SYNECOR Biomaterial, various polypropylene knits and a polyvinylidene fluoride / polypropylene construct. The materials were incubated in S. aureus overnight, rinsed and subjected to staining and analysis through confocal microscopy. This allowed for analysis of where bacteria attached.

Via confocal fluorescence imaging, the interaction ofS. aureus to various knitted polymer materials was compared and it was concluded that: • All bacteria are located only on the surface of the fibers for each type of polymer — PTFE, polypropylene and polyvinylidene fluoride (PVDF). • Bacteria localize to the knots and fiber surfaces of all the knits. • No bacteria were located within the PTFE fiber. • Fewer bacteria were found on PTFE knit fibers than other knits. Overall, bacteria localize to the knots and fiber surfaces of all test articles examined in this study. Confocal images suggest that no bacteria are located within the PTFE knit fibers of the GORE® SYNECOR Biomaterial and overall fewer bacteria are located on PTFE knit fibers of GORE® SYNECOR Biomaterial than other materials.

GORE® SYNECOR Biomaterials Partially absorbable lightweight PTFE knit (10x) Polypropylene knit (10x) polypropylene knit (10x) Polyvinylidene / polypropylene knit (10x) 0.0 0.0 0.0 0.0

0.2 0.2 0.2 0.2

0.4 0.4 0.4 0.4 ) ) ) 0.6 ) 0.6 0.6 0.6 Y (mm Y (mm Y (mm 0.9 Y (mm 0.9 0.9 0.9

1.0 1.0 1.0 1.0

1.2 1.2 1.2 1.2

0.0 0.2 0.4 0.6 0.8 1.0 1.2 0.0 0.2 0.4 0.6 0.8 1.0 1.2 0.0 0.2 0.4 0.6 0.9 1.0 1.2 0.0 0.2 0.4 0.6 0.8 1.0 1.2 X (mm) X (mm) X (mm) X (mm)

S. aureus stains green; red represents the fiber materials as reflected light.

1.9

GORE® SYNECOR Biomaterial

Product overview

Handling and ease of use • No pre-soaking of Biomaterials is needed. • The material is flexible, conforming well to the anatomy and allowing for easy deployment through the trocar. • Material memory facilitates easy unrolling of the mesh after insertion for optimal placement. • The material is appropriate for use during robotic procedures. Absorbs fluid. • Absorbs fluids (i.e. blood); may be dipped in sterile saline to facilitate handling.

For robotic procedures.

1.10 Product use recommendations

GORE® SYNECOR Biomaterial

Product use recommendations

For robotic procedures.

GORE® SYNECOR Intraperitoneal Biomaterial is intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of a non-absorbable reinforcing or bridging material. Hospital surgical departments, including general surgery, trauma and plastics, find value in the material and some common applications include: • Laparoscopic and robotic ventral hernia repair • Open ventral hernia repair • High-risk ventral hernia repair

GORE® SYNECOR Preperitoneal Biomaterial is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of a nonabsorbable reinforcing or bridging material. The material is appropriate for use in open, laparoscopic and robotic procedures. Hospital surgical departments, including general surgery, trauma and plastics, find value in the material. Some common applications include: • Transversus abdominis release (TAR) procedure • Component separation technique • Preperitoneal ventral hernia repair • High-risk ventral hernia repair

2.1

GORE® SYNECOR Intraperitoneal Biomaterial

Product replacement

GORE® SYNECOR Intraperitoneal Biomaterial is less than half the cost of leading biologics* and the cost is favorable compared to other biosynthetics.21 Based on patient selection criteria, clinicians may utilize GORE® SYNECOR Intraperitoneal Biomaterial in place of the following products:

Biologic Biosynthetic Permanent Composite Hybrid Company Product name mesh mesh mesh mesh† mesh‡ ALLERGAN STRATTICE Reconstructive Tissue Matrix • BD® COMPOSIX E/X Mesh • BD® COMPOSIX L/P Mesh • BD® DULEX Mesh • BD® PHASIX ST Mesh • BD® SEPRAMESH IP Composite • BD® VENTRALIGHT ST Mesh • BD® VENTRIO Hernia Patch • BD® VENTRIO ST Hernia Patch • BD® XENMATRIX AB Surgical Graft • BD® XENMATRIX Surgical Graft • COOK® BIODESIGN® Hernia Graft • ETHICON FLEXHD® Structural Acellular Hydrated Dermis • ETHICON XCM BIOLOGIC® Tissue Matrix • FEG TEXTILTECHNIK DYNAMESH®-IPOM • INTEGRA® SURGIMEND® Collagen Matrix • MAQUET C-QUR Mesh • MAQUET C-QUR Mosaic Mesh • MEDTRONIC PARIETEX Optimized Composite (PCOx) Mesh • MEDTRONIC PARIETENE DS Composite Mesh • MEDTRONIC PERMACOL Surgical Implant • MEDTRONIC SYMBOTEX Composite Mesh • RTI SURGICAL TUTOMESH® Fenestrated Bovine Pericardium • RTI SURGICAL TUTOPATCH® ECM Extracellular Matrix • TELA BIO OVITEX Reinforced BioScaffold •

* © 2017 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. † Composite meshes are permanent mesh with an absorbable visceral protection layer. ‡ Hybrid meshes have permanent mesh with a bioabsorbable (biologic or biosynthetic) tissue scaffold material. ALLERGAN and STRATTICE are trademarks of Allergan, Inc. BD, COMPOSIX, DULEX, PHASIX, SEPRAMESH, VENTRALIGHT, VENTRIO and XENMATRIX are trademarks of Becton, Dickinson and Company. COOK and BIODESIGN are trademarks of Cook Medical. ETHICON, FLEXHD and XCM BIOLOGIC are trademarks of Ethicon, Inc. FEG TEXTILTECHNIK and DYNAMESH-IPOM are trademarks of FEG Textiltechnik mbH. INTEGRA and SURGIMEND are trademarks of Integra LifeSciences Corporation. MAQUET and CQUR are trademarks of Maquet Getinge Group. MEDTRONIC, PARIETENE DS, PARIETEX, PERMACOL and SYMBOTEX are trademarks of Medtronic, Inc. RTI SURGICAL, TUTOMESH and TUTOPATCH are trademarks of RTI Surgical, Inc. TELA BIO and OVITEX are trademarks of TELA Bio, Inc. 2.2

GORE® SYNECOR Preperitoneal Biomaterial

Product replacement

GORE® SYNECOR Preperitoneal Biomaterial is less than half the cost of leading biologics* and the cost is favorable compared to other biosynthetics.21 Based on patient selection criteria, clinicians may utilize GORE® SYNECOR Preperitoneal Biomaterial in place of the following products:

Biologic Biosynthetic Permanent Composite Hybrid Company Product name mesh mesh mesh mesh† mesh‡ ALLERGAN STRATTICE Reconstructive Tissue Matrix • ATRIUM PROLITE Mesh • ATRIUM VITAMESH • ATRIUM VITAMESH Blue • BD® 3DMAX Light Mesh • BD® 3DMAX Mesh • BD® BARD® Mesh • BD® PHASIX Mesh • BD® BARD® Soft Mesh • BD® XENMATRIX AB Surgical Graft • BD® XENMATRIX Surgical Graft • COOK® BIODESIGN® Advanced Tissue Repair • ETHICON PROLENE® Soft Polypropylene Mesh • ETHICON PROLENE® Polypropylene Mesh • ULTRAPRO ADVANCED Macroporous ETHICON Partially Absorbable Mesh • ETHICON ULTRAPRO® Partially Absorbable Lightweight Mesh • ETHICON XCM BIOLOGIC® Tissue Matrix • FEG TEXTILTECHNIK DYNAMESH®-PP • INTEGRA® SURGIMEND® Collagen Matrix • MEDTRONIC PARIETEX Lightweight Monofilament Mesh • MEDTRONIC PARIETEX Flat Sheet Mesh • MEDTRONIC PERMACOL Surgical Implant • MEDTRONIC PROGRIP Self-Fixating Mesh • MEDTRONIC VERSATEX Monofilament Mesh • NOVUS SCIENTIFIC TIGR® Matrix Surgical Mesh • RTI SURGICAL® TUTOMESH® Fenestrated Bovine Pericardium • RTI SURGICAL® TUTOPATCH® Bovine Pericardium • TELA BIO OVITEX Reinforced BioScaffold •

* © 2017 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. † Composite meshes are permanent mesh with an absorbable component. ‡ Hybrid meshes have permanent mesh with a bioabsorbable (biologic or biosynthetic) tissue scaffold material. ALLERGAN and STRATTICE are trademarks of Allergan, Inc. ATRIUM, PROLITE and VITAMESH are trademarks of Atrium Medical Corporation. BD, BARD, COMPOSIX, DULEX, PHASIX, SEPRAMESH, VENTRALIGHT, VENTRIO and XENMATRIX are trademarks of Becton, Dickinson and Company. COOK and BIODESIGN are trademarks of Cook Medical. ETHICON, FLEXHD, PROLENE, ULTRAPRO, ULTRAPRO ADVANCED and XCM BIOLOGIC are trademarks of Ethicon, Inc. FEG TEXTILTECHNIK and DYNAMESH-PP are trademarks of FEG Textiltechnik mbH. INTEGRA and SURGIMEND are trademarks of Integra LifeSciences Corporation. MEDTRONIC, PARIETEX, PERMACOL, PROGRIP and VERSATEX are trademarks of Medtronic, Inc. NOVUS SCIENTIFIC and TIGR are trademarks of Novus Scientific. RTI SURGICAL, TUTOMESH and TUTOPATCH are trademarks of RTI Surgical, Inc. TELA BIO and OVITEX are trademarks of TELA Bio, Inc. 2.3

GORE® SYNECOR Biomaterial Value analysis

GORE® SYNECOR Biomaterial

Value analysis: Overview

Cost, quality, outcomes, patient quality of life and societal benefits Healthcare professionals understand that in order to deliver the best patient care possible, they will need to operate beyond the intersection of cost, quality and outcomes. When choosing products for a hospital system, the focus is changing from “cost of product” to “cost of care.” The cost of care extends well beyond surgery, to include follow-up care, procedures, a return to the patient’s previous activities and quality of life. Our analysis of value covers those comprehensive, multi- dimensional factors that we can control, thus providing us with the ability to work with healthcare providers in delivering the greatest impact and value in patient care.

Care Payer Satisfaction Ease of use Provider Quality outcomes Safety Physician Control Care Patient Material design Control Performance Cost Contribute Fitness for use

Contribute Support Training Education Research

3.1

GORE® SYNECOR Biomaterial

Value analysis: Economic

Economic value and mesh selection for hernia repair Reynolds et al., with the University of Kentucky, evaluated their expenditure for surgical hernia meshes for ventral In hernia repair, the cost of the mesh or biomaterial hernia wall repair at a tertiary care referral facility.23 selected is only the first consideration, but it is Losses were greatest in cases involving use of biologic potentially very significant in determining value. mesh, which resulted in a median net financial loss of For example, synthetic hybrid products like GORE® $8,370.00. Biologic mesh more than doubled the direct SYNECOR Biomaterial can be less than half the cost of costs of incisional hernia repair.23 leading biologic meshes* and provide a low cost in use compared to lightweight synthetic meshes that have Surgical mesh units23 Surgical mesh costs23 case studies of failing due to inadequate strength.3,4 GORE® SYNECOR Biomaterial can be used in place of biologic and permanent synthetic meshes in clean and clean high-risk patient types, while providing economic value. Even with biologics providing discounted contract pricing, cost savings with biosynthetics must be evaluated and considered as part of the value analysis in clean high-risk patient types. Clearly, the total cost of care is a critical factor in the value analysis.

Gore 3D PGA:TMC web scaffold technology – Proven results Synthetic mesh Biologic mesh $1,000 GORE® SYNECOR Biomaterial incorporates the same $60 100% $0 Gore 3D PGA:TMC web scaffold technology used in ($1,000) GORE® BIO-A® Tissue Reinforcement, a product backed ($2,000) by documented success: ($3,000) • 12+ years of safe clinical use in complex ventral ($4,000) hernia repair. ($5,000) • More than 250 publications. ($6,000) • Over 1,700 patients in the clinical literature. ($7,000) ® ® Since 2008, GORE BIO-A Tissue Reinforcement has ($8,000) documented success and low recurrence rates in ($9,000) ($8,370) hernia repair. Net profit Patient quality of life after hernia repair Ventral hernia repairs have significant economic Request a custom cost analysis ramifications for patients, employers and insurers In hernia surgery, total cost of care can vary widely if because of the volume of procedures, complication complications occur. To see how the cost of complications can rates, the significant rate of recurrences and escalating affect your hospital’s bottom line, schedule a brief discussion costs. Ventral hernia repairs in the United States are with your local Gore sales associate for a custom value estimated to cost at least $3.2 billion annually based on analysis. To contact your local Gore Field Sales Associate, 2006 data.23 Notably, the report also found that every please call 1 888 925 4673. reduction in recurrence generates substantial cost savings – each one percent reduction would save about $32 million annually.23

GORE® SYNECOR Biomaterial

Value analysis: Preclinical data

Human fibroblast cells grow into GORE® SYNECOR Biomaterial The web layer is designed to encourage cellular penetration and ingrowth of the device. The in vitro analysis demonstrated penetration of human fibroblast cells into the Gore 3D PGA:TMC web scaffold of the device. Overall, the rendering demonstrates penetration of fibroblasts throughout the web of GORE® SYNECOR Biomaterial at eight days.

0.0

0.2

0.4

0.6

Y (mm) 0.9

1.0 Green: fibroblast 1.2 Blue: nuclei and bioabsorbable fibers 0.0 0.2 0.4 0.6 0.9 1.0 1.2 X (mm)

Ingrowth The combination of the Gore 3D PGA:TMC web scaffold and the PTFE knit allows for rapid cellular ingrowth and appropriate tissue integration without negatively affecting abdominal wall compliance typically associated with heavyweight polypropylene meshes.

Studies demonstrated that at 30 days tissue ingrowth was present throughout the device with various densities around the knit fibers and within the web (Data on file 2015; .W L. Gore & Associates, Inc; Flagstaff, AZ). The ingrowth was vascularized, organized and filled the macropores.

This section shows the GORE® SYNECOR Preperitoneal Biomaterial device (Web: black arrows, Fibers: F) filled completely with collagen, vessels (red arrows) and cells. 10x. HE. 30 days (Data on file 2015; .W L. Gore & Associates, Inc; Flagstaff, AZ).

Assessing vascularity via microcomputed tomography (MicroCT), it was shown that as early as seven days post implant, numerous newly formed blood vessels were observed both around and within the GORE® SYNECOR Preperitoneal Biomaterial.14

3.3

GORE® SYNECOR Biomaterial

Value analysis: Clinical data24, 25 GORE® SYNECOR Intraperitoneal Biomaterial Background Approach

• Traditional clinical trials are expensive, inflexible and Figure 1. difficultto apply to the real world.

• 21st Century Cures Act will allow for faster speed to market for new drugs and devices to get to patients.

• Continuous quality improvement (CQI) is a tool from systems and data science that facilitates the measurement and improvement of a complex patient care process.

• GORE ® SYNECOR Intraperitoneal Biomaterial is a new hybrid hernia device cleared in December 2015.

Methods Open Laparoscopic Robotic Open and Lap • Multi-site CQI project for ventral/incisional hernia repair.

® • Evaluated new hybrid hernia device: GORE SYNECOR Results Intraperitoneal Biomaterial. • 10 months to accrue 212 patients. • CQI Exempt from HIPAA and IRB process. • No mesh related complications thus far, however long term • Agency for Healthcare Research and Quality (AHRQ) follow up is in progress. vetted the CQI process as a model for patient safety and quality improvement. • Average hospital length of stay was shorter for patients undergoing robotic and laparoscopic repair compared to • De-identified patient information used for data open (Figure 2). analysis and data visualization. • CQI data analysis and visualization is performed at • 212 patients evaluated in 10 months obtained from each local environment and with the pooled dataset. nine different hernia teams (Table 1).

• Surgeons utilized an open, laparoscopic, combination Co-morbidities open and laparoscopic or robotic approach to hernia Figure 2. repair (Figure 1). Rooti • Data points and outcome measures can be modified aarooi Oe in real time.

Table 1. Data entered Sites and surgeons (#of cases)

New Hanover Regional Medical Center, Dr. W Hope 6 Capital Regional Medical Center, Dr. C Doerhoff 43 University of Tennessee Medical Center, 12 erae oital let o ta Bo a e B reio eria reair Dr. B Ramshaw, Dr. M Mancini, Dr. G Mancini a Marina Del Ray Hospital, Dr. D Marcus 10 Our Lady of the Lake Regional Medical Center, 28 Dr. K LeBlanc Discussion Baptist Hospital, Dr. T Goers 4 • CQI for post market analysis of drugs / devices may Greenville Hospital System, Dr. A Carbonell, 9 provide better value for patients and the medical Dr. W Cobb, Dr. J Warren industry by keeping costs low and generating data Loma Linda University, Dr. M Michelotti 40 Moore Regional Hospital, Dr. D Grantham, quickly for evaluation. Dr. R Washington, Dr. J Fessenden 60 • These results suggest the patients who received Total Cases 212 laparoscopic or robotic repair had shorter hospital length of stay. There were no short-term mesh related complications. 3.4

GORE® SYNECOR Biomaterial

Value analysis: Societal impact

Environmental benefits GORE® SYNECOR Biomaterial is synthetically made in a controlled environment. The product does not utilize human or animal-derived tissue, so there is no risk of cell, disease or virus transmission. Patient benefits • No human/animal-derived tissue alleviates concern or need for patient discussion to consider religious beliefs or cultural practices regarding the use of certain animals or their body parts.26 • Allows for a single surgery with potentially faster recovery and fewer complications. • Helps avoid a staged repair requiring multiple surgeries. Community benefits GORE® SYNECOR Biomaterial was designed with one purpose – Successful outcomes that provide value for: Patients — A single surgery with faster recovery and fewer complications, versus a staged repair requiring multiple surgeries. Surgeons — A single-stage, durable repair in complex cases. Hospitals — Positive clinical outcomes with low cost of use. Payors — An efficient solution in complex cases, with an effective single procedure. The key considerations for your value analysis include: 1. GORE® SYNECOR Intraperitoneal Biomaterial GORE® SYNECOR Intraperitoneal Biomaterial is a cost-effective, easy-to-use hernia repair solution for open, laparoscopic and robotic cases. It is a unique hybrid in combining permanent strength with a tissue-building scaffold. Construction features include: • Gore 3D PGA:TMC web scaffold — A tissue-building scaffold for rapid vascularity and ingrowth. • Latest generation macroporous knit of dense, monofilament PTFE fiber — May reduce the risk of bacteria residing within the knit7 and provides optimum strength for a durable, single-stage repair. • A nonporous PGA:TMC film — Minimizes tissue attachment to the material on the visceral side. 2. GORE® SYNECOR Preperitoneal Biomaterial GORE® SYNECOR Preperitoneal Biomaterial is a cost-effective, easy-to-use hernia repair solution for onlay, retrorectus and preperitoneal placements. It is a unique hybrid in combining permanent strength with a tissue-building scaffold. Construction features include: • Two layers of Gore 3D PGA:TMC web scaffold — A tissue-building scaffold for rapid vascularity and ingrowth on both sides. • Latest generation macroporous knit of dense, monofilament PTFE fiber in GORE® SYNECOR Preperitoneal Biomaterial may reduce the risk of bacteria residing within the knit 7 and along with increased vascularity8 may aid in the overall treatability of the device to minimize the need for removal if postoperative infection were to occur. 3. Those who benefit • General surgeons • Plastic surgeons • Trauma surgeons 4. The financial impact • Low cost of use in comparison to biologic products of similar size, which also may require an additional surgery as they are not intended for bridging. 1,2 • Low cost of use compared to lightweight and mid-weight meshes that have clinical literature case studies demonstrating failure due to inadequate strength in similar indications. 3–5 5. Impact on patient outcomes A single surgery with faster recovery and fewer complications, versus a staged repair requiring multiple surgeries.

3.5 Materials management information

GORE® SYNECOR Biomaterial

Materials management information

GORE® SYNECOR Intraperitoneal Biomaterial product configuration and sizing

Catalogue number Description GKFC12 12 cm diameter circle GKFV1015 10 cm x 15 cm oval G = Gore GKFV1520 15 cm x 20 cm oval K = Knit F = Film GKFR2025 20 cm x 25 cm rectangle C = Circle GKFR2030 20 cm x 30 cm rectangle V = Oval R = Rectangle

GORE® SYNECOR Preperitoneal Biomaterial product configuration and sizing

Catalogue number Description GKWV1015 10 cm x 15 cm oval GKWR1215 12 cm x 15 cm rectangle

GKWV1520 15 cm x 20 cm oval G = Gore K = Knit GKWR2025 20 cm x 25 cm rectangle W=Web GKWR2030 20 cm x 30 cm rectangle V = Oval R = Rectangle

Product specifications GORE® SYNECOR Intraperitoneal Biomaterial is intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of a nonabsorbable reinforcing or bridging material. GORE® SYNECOR Preperitoneal Biomaterial device is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of a non-absorbable reinforcing or bridging material.

Material composition A unique hybrid device composed of a combination of the latest generation macroporous knit of dense, monofilament PTFE fibers and bioabsorbable layers comprised of Gore 3D PGA:TMC web scaffold and a PGA:TMC nonporous film on the visceral surface (intraperitoneal device only). • Gore 3D PGA:TMC web scaffold facilitates cell infiltration and tissue generation. • The macroporous knit of dense, monofilament PTFE fiber in GORE® SYNECOR Biomaterial may reduce the risk of bacteria residing within the knit7, and along with increased vascularity8 may aid in the overall treatability of the device to minimize the need for removal if postoperative infection were to occur. • Nonporous PGA:TMC film minimizes visceral attachment to the material (intraperitoneal device only). Additionally, GORE® SYNECOR Biomaterial does not require any precertification for use but we do offer peer-to-peer education courses for surgeons, residents, fellows, nursing staff, value analysis committees or other administrators. To learn more, please contact your local Gore Field Sales Associate or call 1 888 925 4673.

Coding and reimbursement For a coding and reimbursement guide, visit goremedical.com/coding.

4.1

GORE® SYNECOR Intraperitoneal Biomaterial

FDA clearance

4.2

GORE® SYNECOR Intraperitoneal Biomaterial

FDA clearance

4.3

GORE® SYNECOR Preperitoneal Biomaterial

FDA clearance

4.4

GORE® SYNECOR Preperitoneal Biomaterial

FDA clearance

4.5

GORE® SYNECOR Intraperitoneal Biomaterial

Instructions for use

GORE® SYNECOR Intraperitoneal Biomaterial • Use of this product in applications other than those indicated, including but not limited to those listed below, has the potential Carefully read all instructions prior to use. Observe all instructions, for serious complications: warnings, and precautions noted throughout. Failure to do so may result in complications. – The safety and effectiveness of this device has not been PRODUCT DESCRIPTION established for use in pelvic floor soft tissue deficiencies. Clinical data has shown that use of any surgical mesh in The GORE® SYNECOR Intraperitoneal Biomaterial is a composite pelvic organ prolapse and stress urinary incontinence mesh comprised of a non-absorbable macroporous knit procedures could result in complications, including, constructed of monofilament polytetrafluoroethylene (PTFE) fibers. but not limited to, mesh exposure, mesh erosion, pelvic The visceral surface is a bioabsorbable synthetic nonporous film pain, fistula, dyspareunia, infection, vaginal bleeding or comprised of poly (glycolide:trimethylene carbonate) copolymer discharge, vaginal dysfunction or recurrence, which may (PGA:TMC). The parietal surface is a bioabsorbable synthetic require additional surgery. Further, a positive risk benefit porous fibrous structure comprised of PGA:TMC copolymer. profile for surgical mesh used in transvaginal pelvic Degraded via a combination of hydrolytic and enzymatic organ prolapse repair is not well established in published pathways, the PGA:TMC copolymer has been found to be both literature. biocompatible and nonimmunogenic. In vivo studies with this copolymer indicate the bioabsorption process should be complete – The safety and effectiveness of this device has not been by six to seven months.1 GORE® SYNECOR Intraperitoneal established for use in patients who have a surgical site Biomaterial is designed for intraperitoneal placement. infection that cannot be treated successfully prior to device placement (e.g. use of surgical mesh in an infected surgical site). Use of any surgical mesh in the presence of infection could result in potentially serious patient harms and additional intervention, including surgery. PGA/TMC web BEFORE IMPLANT PROCEDURE • As with any mesh, use of GORE® SYNECOR Intraperitoneal PTFE Knit Biomaterial in the presence of contamination may result in fever, infection, irritation or inflammation, pain, and wound dehiscence and may require removal of the mesh if infection PGA/TMC Film occurs. PROCEDURE INDICATIONS FOR USE • Strict aseptic techniques should be followed. Failure to do so may result in infection and related serious potential patient The GORE® SYNECOR Intraperitoneal Biomaterial device is harms. intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the • Failure to ensure adequate device overlap of the defect may addition of a nonabsorbable reinforcing or bridging material. result in recurrence of the original, or development of an adjacent tissue defect which may lead to bowel obstruction, dysphagia, gastroesophageal reflux disease (GERD) recur- CONTRAINDICATIONS rence, pain, and secondary procedure. ® The GORE SYNECOR Intraperitoneal Biomaterial is contraindicated • As GORE® SYNECOR Intraperitoneal Biomaterial is designed for use in reconstruction of cardiovascular defects. for intraperitoneal placement, the shiny film surface should not be placed adjacent to fascial or subcutaneous tissue WARNINGS AND PRECAUTIONS because it may result in minimal tissue attachment. Persistent Read all instructions carefully. Failure to properly follow the seroma may result and may require additional intervention instructions, warnings, and precautions may lead to serious including surgery to resolve. consequences or injury to the patient (see ADVERSE EVENTS). • Correct surface orientation is important for GORE® SYNECOR Intraperitoneal Biomaterial. Incorrect parietal (nonshiny) sur- WARNINGS face placement with unnecessary contact with internal organs GENERAL may result in adhesions, erosion, extrusion, fistula, infection, • Do not use if the package is opened or damaged, or it is sus- irritation or inflammation, pain, and additional intervention pected that the sterility of the device has been compromised, including surgery. Clinical data on abdominal surgery, with or as infection and related serious potential patient harms could without surgical mesh, has shown that adhesion formation occur. may occur and may result in complications including pain, • Do not use past the “use by” (expiration) date, as this may bowel obstruction, and additional intervention including affect product performance and sterility, resulting in serious surgery. potential harms. • Use of absorbable sutures to secure the mesh in place may • Reuse may result in infection and related serious potential result in inadequate fixation. Ensure staple size and staple or patient harms. See HOW SUPPLIED. tack spacing provides adequate fixation of device to tissue. 4.6

GORE® SYNECOR Intraperitoneal Biomaterial

Instructions for use

Insufficient fixation of the device may result in mesh migration, HOW SUPPLIED erosion or extrusion, hernia recurrence, or recurrence of CONTENTS soft tissue deficiency which may lead to bowel obstruction, The GORE® SYNECOR Intraperitoneal Biomaterial is packaged dysphagia, fistula, GERD recurrence, pain, and additional in a single sterile barrier foil pouch with an internal TYVEK® intervention including surgery. desiccant pocket. The pouch is then placed in an envelope style AFTER IMPLANT PROCEDURE paperboard carton. • When post-operative infection is suspected, debridement STERILITY • The GORE® SYNECOR Intraperitoneal Biomaterial is provided of involved tissues should be considered. If an infection STERILE and non-pyrogenic, and is sterilized by ethylene develops, it should be treated aggressively. An unresolved oxide. Do not resterilize. infection may require removal of the material. • Do not use after the “use by” (expiration) date printed on the • If using this device as a permanent implant and exposure label. Provided that the integrity of the package is not compro- occurs, treat to avoid contamination, or device removal may mised in any way, the package will serve as an effective barrier be necessary. Exposure or protrusion of the device could until the “use by” (expiration) date printed on the label. result in infection, pain, and additional intervention including surgery. • The GORE® SYNECOR Intraperitoneal Biomaterial is designed for single use only; do not reuse device. Gore does not have PRECAUTIONS data regarding reuse of this device. Reuse may cause device The following caution should be considered to ensure the safe and failure or procedural complications including device damage, effective use of the device and protect the safety of the patient. compromised device biocompatibility, and device contamina- • Use of GORE® SYNECOR Intraperitoneal Biomaterial in infants, tion which may lead to patient harms. (See WARNINGS) children or pregnancy where future growth will occur has not STORAGE AND HANDLING been evaluated. • Store in a dry place. Avoid exposing the package or device to extreme hot or cold temperatures. ADVERSE EVENTS • Do not use the GORE® SYNECOR Intraperitoneal if the foil POTENTIAL CLINICAL AND DEVICE ADVERSE EVENTS pouch is compromised or if the device is damaged. Device-related: • To open the package, peel the seal apart from the upper Possible adverse reactions with the use of any tissue deficiency portion of the foil pouch. prosthesis may include, but are not limited to adhesions • Use clean sterile gloves or atraumatic sterile instruments and related harms, bowel obstruction, contamination, defect when handling the GORE® SYNECOR Intraperitoneal Bioma- recurrence and related harms, dysphagia, erosion or extrusion terial. and related harms, exposure or protrusion and related harms, fever, fistula, GERD recurrence, infection, irritation • Handle and dispose of the device and packaging with the or inflammation, mesh migration, mesh shrinkage, pain, necessary precautionary measures in accordance with accept- paresthesia, seroma or hematoma and related harms, tissue able medical practice and with applicable local, state, and ischemia, wound dehiscence, and additional intervention federal laws and regulations. including surgery. • See WARNINGS AND PRECAUTIONS for additional considerations specific to storage and handling. Procedure-related: As with any surgical procedure, there are always risks of For additional Storage and Handling information, see HOW complications for surgical repair of hernias, with or without SUPPLIED. mesh, these may include but are not limited to, adhesions DIRECTIONS FOR USE and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion PHYSICIAN TRAINING REQUIREMENTS The GORE® SYNECOR Intraperitoneal Biomaterial should only and related harms, fever, fistula, GERD recurrence, hernia be used by physicians experienced in the repair of hernias and recurrence, ileus, increased procedure time and related harms, abdominal wall or thoracic wall soft tissue deficiencies. irritation or inflammation, infection, lung function impairment, pain, paresthesia, perforation, revision/resurgery, seroma or DEVICE PREPARATION hematoma and related harms, wound complications and wound • Check information on the product labeling for correct configu- dehiscence. ration, size, and expiration date. Refer to IFU Section WARNING AND PRECAUTIONS for any • Open the carton at the flap on the top of the package and additional information regarding adverse events and any steps remove the pouch. that should be taken to avoid them, as well as information about • Inspect the package and do not use device if the package is other warnings and precautions. damaged or if it is suspected sterility has been compromised. CLINICAL AND DEVICE ADVERSE EVENT REPORTING • Use sterile technique to peel the seal apart from the upper Any adverse event involving the GORE® SYNECOR Intraperitoneal portion of the pouch and remove the device. Biomaterial should be reported to the manufacturer and the • Ensure the size of the mesh is adequate for the intended re- country specific regulatory authorities immediately. To report pair. Use sharp surgical instruments to trim GORE® SYNECOR an event to W. L. Gore & Associates, call: +1.800.528.1866 Ext. Intraperitoneal Biomaterial to ensure appropriate overlap of 44922 or email: [email protected]. 4.7

GORE® SYNECOR Intraperitoneal Biomaterial

Instructions for use

the defect on all sides. If GORE® SYNECOR Intraperitoneal Bio- All fixation devices should be used in accordance with the material is cut too small, excessive tension may be placed on manufacturer’s instructions for use. The physician should the suture line, which may result in recurrence of the original, reference the manufacturer’s instructions for use and any or development of an adjacent, tissue defect. SEE WARNINGS. supporting clinical literature regarding any potential warnings, • GORE® SYNECOR Intraperitoneal Biomaterial does not require precautions, and adverse reactions related to fixation devices. pre-wetting. If desired, GORE® SYNECOR Intraperitoneal Bio- material may be wetted with sterile saline or similar standard See WARNINGS AND PRECAUTIONS for additional considerations irrigation solution prior to placement through a trocar to specific to the procedure. facilitate introduction. See WARNINGS AND PRECAUTIONS for additional considerations MR SAFETY INFORMATION specific to the procedure. GORE® SYNECOR Intraperitoneal Biomaterial is MR Safe. IMPLANT PROCEDURE DEVICE INSERTION REFERENCES • Insert the device through an open incision, trocar incision, or 1. Katz AR, Mukherjee DP, Kaganov AL, Gordon S. A new synthetic introduce through a trocar. Ease of trocar introduction may monofilament absorbable suture made from polytrimethylene vary depending on rolled device size and trocar availability. carbonate. Surgery, Gynecology & Obstetrics 1985;161(3):213- Excessive force should be avoided during trocar introduction 222. to minimize potential for device damage. SURFACE ORIENTATION DEFINITIONS • Ensure correct surface orientation during intraperitoneal placement. One surface of the product has a shiny nonporous film. The shiny film surface should be placed adjacent to those tissues where minimal tissue attachment is desired (i.e., serosal surfaces). The parietal (non-shiny) surface should be placed adjacent to those tissues where ingrowth is desired. SEE WARNINGS. SUTURE FIXATION • Nonabsorbable sutures, such as GORE‑TEX® Suture, of appropriate size with a taper or piercing point needle are recommended to secure the mesh. The use of absorbable sutures may lead to inadequate anchoring of GORE® SYNECOR Intraperitoneal Biomaterial to the host tissue and necessitate reoperation. SEE WARNINGS. • For best results, use monofilament sutures. Suture size should be determined by surgeon preference and the nature of the reconstruction. • When suturing GORE® SYNECOR Intraperitoneal Biomaterial to the host tissue, the mesh should be sutured a minimum distance of 1 cm (0.4 in) from the edge of the device. • Interrupted sutures can provide additional security against recurrence due to suture failure. ALTERNATIVE FIXATION • Permanent staples or helical tacks (also known as helical coils) can be used as an alternative to sutures. • Use of absorbable tack and staple fixation devices with GORE® SYNECOR Intraperitoneal Biomaterial have been evaluated acutely in animal models and shown to be compatible. • Appropriate force should be used when positioning tacking devices to avoid damage to film surface. • Staple size and staple or tack spacing should be determined by surgeon preference to provide for adequate tissue fixation and to prevent reherniation. SEE WARNINGS. • Fixation methods other than those described above have not been evaluated for use with GORE® SYNECOR Intraperitoneal Biomaterial.

4.8

GORE® SYNECOR Preperitoneal Biomaterial

Instructions for use

GORE® SYNECOR Preperitoneal Biomaterial • Use of this product in applications other than those indicated, Carefully read all instructions prior to use. Observe all instructions, including but not limited to those listed below, has the potential warnings, and precautions noted throughout. Failure to do so may for serious complications: result in complications. – The safety and effectiveness of this device has not been PRODUCT DESCRIPTION established for use in pelvic floor soft tissue deficiencies. The GORE® SYNECOR Preperitoneal Biomaterial is a composite Clinical data has shown that use of any surgical mesh in mesh comprised of a non-absorbable macroporous knit pelvic organ prolapse and stress urinary incontinence constructed of monofilament polytetrafluoroethylene (PTFE) procedures could result in complications, including, but not fibers between two layers of bioabsorbable material. The limited to, mesh exposure, mesh erosion, pelvic pain, fis- bioabsorbable layers are a synthetic porous fibrous structure tula, dyspareunia, infection, vaginal bleeding or discharge, comprised of poly(glycolide:trimethylene carbonate) copolymer vaginal dysfunction or recurrence, which may require (PGA:TMC). Degraded via a combination of hydrolytic and additional surgery. Further, a positive risk benefit profile for enzymatic pathways, the PGA:TMC copolymer has been found surgical mesh used in transvaginal pelvic organ prolapse to be both biocompatible and non-immunogenic. In vivo repair is not well established in published literature. studies with this copolymer indicate the bioabsorption process – The safety and effectiveness of this device has not been should be complete by six to seven months.1 GORE® SYNECOR established for use in patients who have a surgical site Preperitoneal Biomaterial is designed for preperitoneal infection that cannot be treated successfully prior to device placement and should be placed between tissue layers where placement (e.g. use of surgical mesh in an infected surgical ingrowth is desired. site). Use of any surgical mesh in the presence of infection could result in potentially serious patient harms and additional intervention, including surgery. BEFORE IMPLANT PROCEDURE • As with any mesh, use of GORE® SYNECOR Preperitoneal Biomaterial in the presence of contamination may result in fever, infection, irritation or inflammation, pain, and wound dehiscence and may require removal of the mesh if infection occurs. PROCEDURE • Strict aseptic techniques should be followed. Failure to do so INDICATIONS FOR USE may result in infection and related serious potential patient harms. The GORE® SYNECOR Preperitoneal Biomaterial device is • Failure to ensure adequate device overlap of the defect may intended for use in the repair of hernias and abdominal wall result in recurrence of the original, or development of an soft tissue deficiencies that may require the addition of a adjacent tissue defect which may lead to bowel obstruction, non-absorbable reinforcing or bridging material. dysphagia, gastroesophageal reflux disease (GERD) recurrence, pain, and secondary procedure. CONTRAINDICATIONS • Placing the PGA:TMC porous web with unnecessary con- The GORE® SYNECOR Preperitoneal Biomaterial is contraindicated tact with internal organs may result in adhesions, erosion, for use in reconstruction of cardiovascular defects. extrusion, fistula, infection, irritation or inflammation, pain, and additional intervention including surgery. Clinical data on WARNINGS AND PRECAUTIONS abdominal surgery, with or without surgical mesh, has shown that adhesion formation may occur and may result in com- Read all instructions carefully. Failure to properly follow the plications including pain, bowel obstruction, and additional instructions, warnings, and precautions may lead to serious intervention including surgery. consequences or injury to the patient (see ADVERSE EVENTS). • Use of absorbable sutures to secure the mesh in place may WARNINGS result in inadequate fixation. Ensure staple size and staple or GENERAL tack spacing provides adequate fixation of device to tissue. • Do not use if the package is opened or damaged, or it is sus- Insufficient fixation of the device may result in mesh migra- pected that the sterility of the device has been compromised, tion, erosion or extrusion, hernia recurrence, or recurrence of as infection and related serious potential patient harms could soft tissue deficiency which may lead to bowel obstruction, occur. dysphagia, fistula, GERD recurrence, pain, and additional intervention including surgery. • Do not use past the “use by” (expiration) date, as this may affect product performance and sterility, resulting in serious AFTER IMPLANT PROCEDURE potential harms. • When post-operative infection is suspected, debridement • Reuse may result in infection and related serious potential of involved tissues should be considered. If an infection patient harms. See HOW SUPPLIED. develops, it should be treated aggressively. An unresolved infection may require removal of the material. 4.9

GORE® SYNECOR Preperitoneal Biomaterial

Instructions for use

• If using this device as a permanent implant and exposure • Do not use after the “use by” (expiration) date printed on the occurs, treat to avoid contamination, or device removal may be label. Provided that the integrity of the package is not compro- necessary. Exposure or protrusion of the device could result in mised in any way, the package will serve as an effective barrier infection, pain, and additional intervention including surgery. until the “use by” (expiration) date printed on the label.

® PRECAUTIONS • The GORE SYNECOR Preperitoneal Biomaterial is designed for single use only; do not reuse device. Gore does not have data The following caution should be considered to ensure the safe and regarding reuse of this device. Reuse may cause device failure effective use of the device and protect the safety of the patient. or procedural complications including device damage, com- • Use of GORE® SYNECOR Preperitoneal Biomaterial in infants, promised device biocompatibility, and device contamination children or pregnancy where future growth will occur has not which may lead to patient harms. (See WARNINGS) been evaluated. STORAGE AND HANDLING ADVERSE EVENTS • Store in a dry place. Avoid exposing the package or device to POTENTIAL CLINICAL AND DEVICE ADVERSE EVENTS extreme hot or cold temperatures. Device-related: • Do not use the GORE® SYNECOR Preperitoneal if the foil pouch Possible adverse reactions with the use of any tissue deficiency is compromised or if the device is damaged. prosthesis may include, but are not limited to adhesions • To open the package, peel the seal apart from the upper and related harms, bowel obstruction, contamination, defect portion of the foil pouch. recurrence and related harms, dysphagia, erosion or extrusion • Use clean sterile gloves or atraumatic sterile instruments when and related harms, exposure or protrusion and related handling the GORE® SYNECOR Preperitoneal Biomaterial. harms, fever, fistula, GERD recurrence, infection, irritation or inflammation, mesh migration, mesh shrinkage, pain, • Handle and dispose of the device and packaging with the paresthesia, seroma or hematoma and related harms, tissue necessary precautionary measures in accordance with ischemia, wound dehiscence, and additional intervention acceptable medical practice and with applicable local, state, including surgery. and federal laws and regulations. • See WARNINGS AND PRECAUTIONS for additional Procedure-related: considerations specific to storage and handling. As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without For additional Storage and Handling information, see HOW mesh, these may include but are not limited to, adhesions and SUPPLIED. related harms, bleeding, bowel obstruction, dysphagia, erosion DIRECTIONS FOR USE or extrusion and related harms, exposure or protrusion and PHYSICIAN TRAINING REQUIREMENTS related harms, fever, fistula, GERD recurrence, hernia recurrence, The GORE® SYNECOR Preperitoneal should only be used by ileus, increased procedure time and related harms, irritation or physicians experienced in the repair of hernias and abdominal wall inflammation, infection, pain, paresthesia, perforation, revision/ soft tissue deficiencies. resurgery, seroma or hematoma and related harms, wound complications and wound dehiscence. DEVICE PREPARATION • Check information on the product labeling for correct Refer to IFU Section WARNING AND PRECAUTIONS for any configuration, size, and expiration date. additional information regarding adverse events and any steps that should be taken to avoid them, as well as information about • Open the carton at the flap on the top of the package and other warnings and precautions. remove the pouch. • Inspect the package and do not use device if the package is CLINICAL AND DEVICE ADVERSE EVENT REPORTING damaged or if it is suspected sterility has been compromised. Any adverse event involving the GORE® SYNECOR Preperitoneal Biomaterial should be reported to the manufacturer and the country • Use sterile technique to peel the seal apart from the upper specific regulatory authorities immediately. To report an event to W. portion of the pouch and remove the device. L. Gore & Associates, call: +1.800.528.1866 Ext. 44922 or email: • Ensure the size of the mesh is adequate for the intended [email protected]. repair. Use sharp surgical instruments to trim GORE® SYNECOR Preperitoneal Biomaterial to ensure appropriate overlap of the HOW SUPPLIED defect on all sides. If GORE® SYNECOR Preperitoneal Biomate- CONTENTS rial is cut too small, excessive tension may be placed on the The GORE® SYNECOR Preperitoneal Biomaterial is packaged in a suture line, which may result in recurrence of the original, or single sterile barrier foil pouch with an internal TYVEK® desiccant development of an adjacent, tissue defect. SEE WARNINGS. pocket. The pouch is then placed in an envelope style paperboard • GORE® SYNECOR Preperitoneal Biomaterial does not require carton. pre-wetting. If desired, GORE® SYNECOR Preperitoneal Bio- STERILITY material may be wetted with sterile saline or similar standard • The GORE® SYNECOR Preperitoneal Biomaterial is provided irrigation solution prior to placement to facilitate introduction. STERILE and non-pyrogenic, and is sterilized by ethylene oxide. Do not resterilize. See WARNINGS AND PRECAUTIONS for additional considerations specific to the procedure. 4.10

GORE® SYNECOR Preperitoneal Biomaterial

Instructions for use

IMPLANT PROCEDURE All fixation devices should be used in accordance with the DEVICE INSERTION manufacturer’s instructions for use. The physician should • Insert the device through an open incision, trocar incision, or reference the manufacturer’s instructions for use and any introduce through a trocar. Excessive force should be avoided supporting clinical literature regarding any potential warnings, during trocar introduction to minimize potential for device precautions, and adverse reactions related to fixation devices. damage. See WARNINGS AND PRECAUTIONS for additional considerations • Removing the trocar seal can help facilitate deployment. Ease of specific to the procedure. introduction may vary depending on rolled device size and trocar variability. See Table 1 for the minimum recommended trocar MR SAFETY INFORMATION size. GORE® SYNECOR Preperitoneal Biomaterial is MR Safe. TABLE 1: MINIMUM RECOMMENDED TROCAR SIZE

MINIMUM RECOMMENDED REFERENCES DEVICE SIZE TROCAR SIZE 1. Katz AR, Mukherjee DP, Kaganov AL, Gordon S. A new synthetic 10 cm x 15 cm 10 mm monofilament absorbable suture made from polytrimethylene carbonate. Surgery, Gynecology & Obstetrics 1985;161(3):213- 12 cm x 15 cm 11 mm 222. 15 cm x 20 cm 12 mm 20 cm x 25 cm 15 mm DEFINITIONS 20 cm x 30 cm* 15 mm * Recommended wetting for ease of introduction

DEVICE PLACEMENT • It is recommended that GORE® SYNECOR Preperitoneal Biomaterial be placed next to well-vascularized tissue. SEE WARNINGS.

SUTURE FIXATION • Nonabsorbable sutures, such as GORE‑TEX® Suture, of appropriate size with a taper or piercing point needle are recommended to secure the mesh. The use of absorbable sutures may lead to inadequate anchoring of GORE® SYNECOR Preperitoneal Biomaterial to the host tissue and necessitate reoperation. SEE WARNINGS. • For best results, use monofilament sutures. Suture size should be determined by surgeon preference and the nature of the reconstruction. • When suturing GORE® SYNECOR Preperitoneal Biomaterial to the host tissue, the mesh should be sutured a minimum distance of 1 cm (0.4”) from the edge of the device. • Interrupted sutures can provide additional security against recurrence due to suture failure.

ALTERNATIVE FIXATION • Permanent staples or helical tacks (also known as helical coils) can be used as an alternative to sutures. • Use of absorbable tack and staple fixation devices with GORE® SYNECOR Preperitoneal Biomaterial has been shown to be compatible. • Staple size and staple or tack spacing should be determined by surgeon preference to provide for adequate tissue fixation and to prevent reherniation. SEE WARNINGS. • Fixation methods other than those described above have not been evaluated for use with GORE® SYNECOR Preperitoneal Biomaterial.

4.11 References

GORE® SYNECOR Biomaterial

About Gore

W. L. Gore & Associates, Inc. Inspired by challenges, committed to performance.

• Founded January 1, 1958 • Privately held • Over $3.2 billion in annual sales – Associates held to a high standard – You and your needs are our focus

Gore Medical Products Division Together, improving life Gore core technology ePTFE fluoropolymers

FABRICS MEDICAL PRODUCTS PERFORMANCE SOLUTIONS

VASCULAR GENERAL MEDICAL PRODUCTS CARDIAC

5.1

GORE® SYNECOR Biomaterial

References

1. Blatnik J, Jin J, Rosen M. Abdominal hernia repair with bridging acellular dermal matrix—an expensive hernia sac. American Journal of Surgery 2008;196:47–50. 2. Giordano S, Garvey PB, Baumann DP, Liu J, Butler CE. Primary fascial closure with biologic mesh reinforcement results in lesser complication and recurrence rates than bridged biologic mesh repair for abdominal wall reconstruction: a propensity score analysis. Surgery 2017;161(2):499-508. 3. Petro CC, Nahabet EH, Criss CN, et al. Central failures of lightweight monofilament polyester mesh causing hernia recurrence: a cautionary note. Hernia 2015;19(1):155-159. 4. Cobb WS, Warren JA, Ewing JA, Burnikel A, Merchant M, Carbonell AM. Open retromuscular mesh repair of complex incisional hernia: predictors of wound events and recurrence. Journal of the American College of Surgeons 2015;220(4):606-613. 5. Warren JA, McGrath SP, Hale AL, Ewing JA, Carbonell AM 2nd, Cobb WS 4th. Patterns of recurrence and mechanisms of failure after open ventral hernia repair with mesh. American Surgeon 2017;83(11):1275-1282. 6. LeBlanc KA, Heniford BT, Voeller GR. Innovations in ventral hernia repair. Materials and techniques to reduce MRSA and other infections. Contemporary Surgery 2006;62(4)Supplement:1-8. 7. Clinger L. PTFE Knit Microbial Placement. Flagstaff, AZ; W. L. Gore & Associates, Inc; 2018. [Workplan]. WP110158. 8. Hollinger, Jeffrey O., ed. An introduction to biomaterials. CRC press, 2012, Section 6.4.5 Host Response to Porous Materials, p.100. 9. Klinge U, Klosterhalfen B, Conze J, et al. Modified mesh for hernia repair that is adapted to the physiology of the abdominal wall. European Journal of Surgery 1998;164(12):951-960. 10. Zhu LM, Schuster P, Klinge U. Mesh implants: an overview of crucial mesh parameters. World Journal of Gastrointestinal Surgery 2015; 7(10):226-236. 11. ASTM D3787-16, Standard Test Method for Bursting Strength of Textiles—Constant-Rate-of-Traverse (CRT) Ball Burst Test, ASTM International, West Conshohocken, PA, 2016, www.astm.org 12. Lake SP, Ray S, Zihni AM, Thompson DM Jr, Gluckstein J, Deeken CR. Pore size and pore shape – but not mesh density – alter the mechanical strength of tissue ingrowth and host tissue response to synthetic mesh materials in a porcine model of ventral hernia repair. Journal of the Mechanical Behavior of Biomedical Materials 2015; 42:186-197. 13. Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze J, Schumpelick V. Impact of polymer pore size on the interface scar formation in a rat model. Journal of Surgical Research 2002;103(2):208-214. 14. Crawford N. Assessment of Vascularity via Micro CT in Various Patch Devices. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2016. [Final study report]. 2344TL. 15. Berman A. A Rabbit Model for the Biomechanical and Histological Assessment of Suture Line Wound Healing. Flagstaff, AZ: W.L. Gore & Associates, Inc.; 2008. [Corporate protocol]. 1978SC. 16. Morales-Conde S, Flores M, Fernández V, Morales-Méndez S. Bioabsorbable vs polypropylene plug for the “Mesh and Plug” inguinal hernia repair. Poster presented at the 9th Annual Meeting of the American Hernia Society; February 9-12, 2005; San Diego, CA. 17. Welty G, Klinge U, Klosterhalfen B, Kasperk R, Schumpelick V. Functional impairment and complaints following incisional hernia repair with different polypropylene meshes. Hernia. 2001;5(3):142-147. 18. Sharkawy AA, Klitzman B, Truskey GA, Reichert WM. Engineering the tissue which encapsulates subcutaneous implants, II. Plasma-tissue exchange properties. Journal of Biomedical materials Research 1998;40(4):586-597. 19. Rosengren A, Bjursten LM. Pore size in implanted polypropylene filters is critical for tissue organization. Journal of Biomedical Materials Research. Part A 2003;67(3):918-926. 20. Matthews BD, Mostafa G, Carbonell AM, Joels CS, Kercher KW, Austin C, Heniford BT. (2005). Evaluation of adhesion formation and host tissue response to intra-abdominal polytetrafluoroethylene mesh and composite prosthetic mesh. Journal of Surgical Research, 13(2), 227-234. 21. Kim M, Oommen B, Ross SW, et al. The current status of biosynthetic mesh for ventral hernia repair. Surgical Technology International 2014;25:114-121 22. Poulose BK, Sherlton J, Phillips S, et al. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia 2012;169(2):179-183. 23. Reynolds D, Davenport DL, Korosec RL, Roth S. Financial implications of ventral hernia repair: a hospital cost analysis. Journal of Gastrointestinal Surgery 2013;17(1):159-167. 24. Carbonell A, Cobb W, Doerhoff C, et al. Clinical Quality Improvement (CQI): a post market method to evaluate a new mesh for ventral/incisional hernia repair. Presented at the Annual American College of Surgeons Clinical Congress; October 22-26, 2017; San Diego, CA. 25. Grimsley L, Forman B, Carbonell A, et al. Evaluating the real world use of a new hybrid hernia mesh. Presented at the 2018 International Hernia Congress, March 12-15, 2018, Miami, FL. Hernia 2018;22(1)Supplement:S178. P-1316. 26. Jenkins ED, Yip M, Melman L, Frisella MM, Matthews BD. Informed consent: cultural and religious issues associated with the use of allogeneic and xenogeneic mesh products. Journal of the American College of Surgeons 2010;210(4):402-410.

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