Value analysis committee product information kit. Strength Plus Scaffold

Transcription

1 Value analysis committee product information kit Strength Plus Scaffold

2 Table of contents Product overview Key considerations 1.1 Applications 1.3 Optimum strength 1.4 Rapid cell migration and vascularization 1.5 Effect of pore size 1.5 Ingrowth 1.6 Tissue response 1.6 Rapid vascularity 1.7 Shrinkage 1.7 Adhesions 1.7 Bacterial adherence 1.8 Handling 1.9 Product use recommendations Product use recommendations 2.1 Product replacement 2.2 Value analysis Overview 3.1 Economic 3.2 Clinical data 3.3 Societal impact 3.4 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 4.4 References 5.1

3 Product overview

4 Product overview The GORE SYNECOR Intraperitoneal Biomaterial is the solution delivering rapid vascularity with permanent strength. It is a cost-effective, easy-to-use solution for open, laparoscopic, and robotic cases that combines: Rapid vascularity and ingrowth Durable, single-stage repair Minimizes attachment at visceral side GORE SYNECOR Intraperitoneal 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 product 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 combining permanent strength with a tissue-building scaffold. Construction features include: GORE BIO-A Web A tissue-building scaffold for rapid vascularity and ingrowth Latest generation macroporous knit of dense, monofilament PTFE fiber May reduce risk of harboring bacteria due to solid fiber and provide optimum strength for a durable, single-stage repair A nonporous polyglycolic acid (PGA) / trimethylene carbonate (TMC) film 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 Impact on patient outcomes A single surgery with faster recovery and fewer complications, versus a staged repair requiring multiple surgeries 1.1

5 Product overview GORE SYNECOR Intraperitoneal Biomaterial is a unique combination of a macroporous knit of dense, monofilament PTFE fibers and a bioabsorbable copolymer scaffold comprised of PGA and TMC on the parietal surface, and a PGA / TMC nonporous 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 BIO-A Web Macroporous PTFE knit PGA / TMC film GORE BIO-A 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 harboring bacteria Nonporous PGA / TMC film minimizes visceral attachment to the material Desirable attributes Favorable for high risk wounds and challenging hernia repairs Rapid vascularity Low profile High strength Desirable attributes Less foreign material Potentially lower inflammation Desirable attributes Appropriate for bridging Long-term durability 1.2

6 Product overview 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 material is 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 3 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 may reduce the risk of harboring bacteria due to the solid fiber. GORE SYNECOR Biomaterial: Macroporous knit of dense monofilament PTFE fiber Polypropylene knit 1.3

7 Product overview Optimum strength for high BMIs, multiple co-morbidities, and complex repairs GORE SYNECOR Intraperitoneal Biomaterial is 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 biomaterial must be able to serve its intended use 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 Intraperitoneal 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 *,7 Literature suggests the strength requirement for bridging ventral hernia repair has an abdominal wall surface tension of 32 N / cm. 8,9 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, ASTM D Ball burst strength (N) 0 Reducing risk of recurrence 0 MEDTRONIC PARIETEX Optimized Composite Mesh BARD Soft Mesh 580 N Improving tissue response Minimum pore size (mm) 1.59 mm ETHICON ULTRAPRO Partially Absorbable Lightweight Mesh MEDTRONIC SYMBOTEX Composite Mesh The macroporous knit of dense, monofilament PTFE fibers provide optimum strength for a durable, single-stage repair. Equivalent 47.8 N / cm Line 9 Potential tensile strength needed for obese patients Equivalent 32 N / cm Line 3 Strength measurement for GORE SYNECOR Intraperitoneal 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 ingrowth 10 and reduced scar plate formation 11 * Data on file 2016; W. L. Gore & Associates, Inc; Flagstaff, AZ. 1.4

8 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 Intraperitoneal 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. Gradually, over approximately six to seven months, the web component is gradually absorbed by the body, and replaced 1:1 with the patient s own favorable Type I collagen. GORE BIO-A Web scaffold facilitates cell infiltration and tissue generation Nonporous PGA / TMC film minimizes visceral attachment to the material Engineering tissue response with material structure The PTFE knit layer of GORE SYNECOR Intraperitoneal Biomaterial is a macroporous construct of large pores; average pore size is 1.59 mm (Figure 1). The web layer forms interconnected pores that are similar in structure to a collagen fiber network (Figure 2). The effect of pore size 12,13 1 mm MACROPOROUS PTFE KNIT Tissue ingrowth device (macroporous) 100 µm 10 µm GORE BIO-A WEB SCAFFOLD OPTIMAL PORE SIZE RANGE: Tissue ingrowth and tissue generating / angiogenic device with optimal porosity for cellular infiltration and vascularization GORE BIO-A Web (GORE BIO-A Tissue Reinforcement) (SEM 100x). Figure 1. Collagen gel. Figure

9 Product overview Tissue ingrowth The combination of the GORE BIO-A 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. Studies 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. 14 Fibrous Tissue Ingrowth 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 180 days 31 days HE polarized 4x At 31 days, the 3 layers of the device are evident. The PGA:TMC film (yellow) has begun to bioabsorb with fragmentation visible. The GORE BIO-A Web layer (Orange) shows signs of bioabsorption with aggregation of web fibers. The PTFE knit fibers are visible (blue). HE polarized 10x At 180 days, the GORE BIO-A web is absorbed and there is organized tissue ingrowth with minimal tissue encapsulation of the PTFE knit. Overall the tissue response and fibrous tissue ingrowth was similar between GORE SYNECOR lntraperitoneal Biomaterial and a lightweight polypropylene. 1.6

10 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 Intraperitoneal Biomaterial. 15 Arrows indicate area where blood vessels are penetrating through the PTFE knit at seven days post-implantation. Shrinkage All biomaterials, including polypropylene, polyester, and the macroporous PTFE knit, will contract to some degree after implantation due to the activity of myofibroblasts during wound healing. Animal studies show GORE SYNECOR Intraperitoneal Biomaterial has minimal shrinkage at 30 and 180 days. 14,16 Adhesions Typical neoperitonealization is thought to occur within 5 to 8 days 17 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. 14,16 1.7

11 Product overview Bacterial adherence 18 Bacterial adherence was examined among various materials, including, the PTFE knit of GORE SYNECOR Intraperitoneal 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 of S. 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 knit 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 and overall fewer bacteria are located on PTFE knit fibers than other materials. 0.0 PTFE knit (10x) 0.0 Polypropylene knit (10x) 0.0 Partially absorbable lightweight polypropylene knit (10x) Polyvinylidene / polypropylene knit (10x) Y (mm) Y (mm) Y (mm) Y (mm) X (mm) X (mm) X (mm) X (mm) S. aureus stains green; red represents the fiber materials as reflected light. 1.8

12 Product overview Handling No pre-soaking of GORE SYNECOR Intraperitoneal Biomaterial is needed The material is soft and conformable, 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 1.9

13 Product use recommendations

14 Product use recommendations 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 ventral hernia repair Open ventral hernia repair High risk ventral hernia repair 2.1

15 Product replacement GORE SYNECOR Intraperitoneal Biomaterial is less than half the cost of leading biologics, * and cost is favorable compared to other biosynthetics. 19 Based on patient selection criteria, clinicians may utilize GORE SYNECOR Intraperitoneal Biomaterial in place of the following products: Company Product name Biologic mesh Biosynthetic mesh Permanent mesh Composite mesh ** Hybrid mesh ALLERGAN STRATTICE Reconstructive Tissue Matrix BARD COMPOSIX E/X Mesh BARD COMPOSIX L/P Mesh BARD DULEX Mesh BARD SEPRAMESH IP Composite BARD VENTRALIGHT ST Mesh BARD VENTRIO Hernia Patch BARD VENTRIO ST Hernia Patch BARD XENMATRIX AB Surgical Graft BARD XENMATRIX Surgical Graft BARD DAVOL PHASIX ST Mesh COOK BIODESIGN Hernia Graft COOK ZENAPRO Hybrid Hernia Repair Device ETHICON FLEXHD Structural Acellular Hydrated Dermis ETHICON XCM BIOLOGIC Tissue Matrix INTEGRA SURGIMEND Collagen Matrix KEBOMED DYNAMESH IPOM Composite Mesh MAQUET C-QUR Mesh MAQUET C-QUR Mosaic Mesh MEDTRONIC PARIETEX Optimized Composite (PCOx) 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. 2.2

16 Value analysis

17 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 Control Contribute Payer Provider Physician Patient Care Satisfaction Ease of use Quality outcomes Safety Control Material design Performance Cost Fitness for use Contribute Support Training Education Research 3.1

18 Value analysis: Economic Economic value and mesh selection for hernia repair In hernia repair, the cost of the mesh or biomaterial selected is only the first consideration, but it is potentially very significant in determining value. For example, a synthetically made biosynthetic product like GORE SYNECOR Intraperitoneal Biomaterial can be less than half the cost of leading biologic meshes * and provide a low cost in use compared to lightweight synthetic meshes that have that have case studies of failing due to inadequate strength. 3,4 GORE SYNECOR Intraperitoneal 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 BIO-A Web Technology Proven results GORE SYNECOR Intraperitoneal Biomaterial incorporates the same GORE BIO-A Web Technology used in GORE BIO-A Tissue Reinforcement, a product backed by documented success: Ten years of safe clinical use in complex ventral hernia repair More than 150 publications Over 1,700 patients in the clinical literature Since 2008, GORE BIO-A Tissue Reinforcement has documented success and low recurrence rates in hernia repair. Patient quality of life after hernia repair Ventral hernia repairs have significant economic ramifications for patients, employers, and insurers because of the volume of procedures, complication rates, the significant rate of recurrences, and escalating costs. Ventral hernia repairs in the United States are estimated to cost at least $3.2 billion annually based on 2006 data. 20 Notably, the report also found that every reduction in recurrence generates substantial cost savings each one percent reduction would save about $32 million annually. 20 Reynolds et al., with the University of Kentucky, evaluated their expenditure for surgical hernia meshes for ventral hernia wall repair at a tertiary care referral facility. 21 Losses were greatest in cases involving use of biologic mesh, which resulted in a median net financial loss of $8, Biologic mesh more than doubled the direct costs of incisional hernia repair. 21 Surgical mesh units 21 Surgical mesh costs 21 $1,000 $0 ($1,000) ($2,000) ($3,000) ($4,000) ($5,000) ($6,000) ($7,000) ($8,000) Synthetic mesh Biologic mesh $60 100% ($9,000) ($8,370) Net profit Request a custom cost analysis In hernia surgery, total cost of care can vary widely if complications occur. To see how the cost of complications can affect your hospital s bottom line, schedule a brief discussion with your local Gore sales associate for a custom value analysis. To contact your local Gore sales associate, please call * 2017 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. 3.2

19 Value analysis: Clinical data 22,23 Background Traditional clinical trials are expensive, inflexible and difficult to 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 approved in December 2015 Approach Figure 1. Methods Multi-site CQI project for ventral / Incisional hernia repair Evaluated new hybrid hernia device: GORE SYNECOR Intraperitoneal Biomaterial CQI Exempt from HIPAA and IRB process Agency for Healthcare Research and Quality (AHRQ) vetted the CQI process as a model for patient safety and quality improvement De-identified patient information used for data analysis and data visualization 212 patients evaluated in 10 months obtained from nine different hernia teams (Table 1) Surgeons utilized an open, laparoscopic, combination open and laparoscopic or robotic approach to hernia repair (Figure 1) Data points and outcome measures can be modified in real time Results 10 months to accrue 212 patients No mesh related complications thus far, however long term follow up is in progress Average hospital length of stay was shorter for patients undergoing robotic and laparoscopic repair compared to open (Figure 2) CQI data analysis and visualization is performed at each local environment and with the pooled dataset Co-morbidities Figure 2. Robotic Laparoscopic Open Open Laparoscopic Robotic Open and Lap Sites and surgeons Table 1. New Hanover Regional Medical Center, Dr. W Hope 6 Capital Regional Medical Center, Dr. C Doerhoff 43 Data entered (#of cases) University of Tennessee Medical Center, Dr. B Ramshaw, Dr. M Mancini, Dr. G Mancini 12 Marina Del Ray Hospital, Dr. D Marcus 10 Our Lady of the Lake Regional Medical Center, Dr. K LeBlanc 28 Baptist Hospital, Dr. T Goers 4 Greenville Hospital System, Dr. A Carbonell, Dr. W Cobb, Dr. J Warren 9 Loma Linda University, Dr. M Michelotti 40 Moore Regional Hospital, Dr. D Grantham, Dr. R Washington, Dr. J Fessenden 60 Total Cases Average hospital length of stay (Days) Discussion CQI for post market analysis of drugs / devices may provide better value for patients and the medical industry by keeping costs low and generating data quickly for evaluation These results suggest the patients who received laparoscopic or robotic repair had shorter hospital length of stay. There were no short-term mesh related complications Body Mass Index (BMI) Previous hernia repair (%)

20 Value analysis: Societal impact Environmental benefits GORE SYNECOR Intraperitoneal 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 24 Allows for a single surgery Faster recovery Fewer complications Helps avoid a staged repair requiring multiple surgeries Community benefits GORE SYNECOR Intraperitoneal 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. The product 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 BIO-A Web A tissue-building scaffold for rapid vascularity and ingrowth Latest generation macroporous knit of dense, monofilament PTFE fiber May reduce the risk of harboring bacteria due to the solid fiber, 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. Those who benefit General surgeons Plastic surgeons Trauma surgeons 3. 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 Impact on patient outcomes A single surgery with faster recovery and fewer complications, versus a staged repair requiring multiple surgeries 3.4

21 Materials management information

22 Materials management information Product configuration and sizing Catalogue number GKFC12 GKFV1015 GKFV1520 GKFR2025 GKFR2030 Description 12 cm diameter circle 10 cm x 15 cm oval 15 cm x 20 cm oval 20 cm x 25 cm rectangle 20 cm x 30 cm rectangle G = Gore K = Knit F = Film C = Circle 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 non-absorbable reinforcing or bridging material. Material composition A unique combination of the latest generation macroporous knit of dense, monofilament PTFE fibers and a bioabsorbable copolymer scaffold comprised of PGA and TMC on the parietal surface, and a PGA / TMC nonporous film on the visceral surface. GORE BIO-A Web scaffold facilitates cell infiltration and tissue generation A macroporous knit of dense, monofilament PTFE fiber, which may reduce the risk of harboring bacteria due to the solid fiber Nonporous PGA / TMC film minimizes visceral attachment to the material Additionally, GORE SYNECOR Intraperitoneal 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 sales associate or call Coding and reimbursement For a coding and reimbursement guide, visit goremedical.com/synecorip. 4.1

23 FDA clearance 4.2

24 FDA clearance 4.3

25 Instructions for use GORE SYNECOR Intraperitoneal Biomaterial INDICATIONS The GORE SYNECOR Intraperitoneal Biomaterial device 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. CONTRAINDICATIONS Not for reconstruction of cardiovascular defects. DESCRIPTION GORE SYNECOR Intraperitoneal Biomaterial is a composite mesh comprised of a non-absorbable macroporous knit constructed of monofilament PTFE fibers. The visceral surface is a bioabsorbable synthetic nonporous film comprised of poly(glycolide:trimethylene carbonate) copolymer (PGA:TMC). The parietal surface is a bioabsorbable synthetic porous fibrous structure comprised of PGA:TMC copolymer. PGA / TMC Web PTFE Knit PGA / TMC Film STERILITY GORE SYNECOR Intraperitoneal Biomaterial is sterilized by ethylene oxide and supplied STERILE. Provided that the integrity of the package is not compromised in any way, the package will serve as an effective barrier until the use by (expiration) date printed on the box. GORE SYNECOR Intraperitoneal Biomaterial is designed for single use only; do not reuse device. Gore does not have data regarding reuse of this device. Reuse may cause device failure or procedural complications including device damage, compromised device biocompatibility, and device contamination. Reuse may result in infection, serious injury, or patient death. SURFACE ORIENTATION Correct surface orientation is important for GORE SYNECOR Intraperitoneal Biomaterial to function as intended. One surface of the product has a shiny nonporous film. This shiny film surface should be placed adjacent to those tissues where minimal tissue attachment is desired (i.e., serosal surfaces). The other (nonshiny) surface should be placed adjacent to those tissues where ingrowth is desired. RECOMMENDED TECHNIQUES HANDLING Use clean, sterile gloves and/or atraumatic instruments when handling GORE SYNECOR Intraperitoneal Biomaterial. PREPARATION GORE SYNECOR Intraperitoneal Biomaterial does not require pre-wetting. If desired, GORE SYNECOR Intraperitoneal Biomaterial may be wetted with sterile saline or similar standard irrigation solution prior to placement through a trocar to facilitate introduction. SIZING Cutting GORE SYNECOR Intraperitoneal Biomaterial to the proper size is essential. Use sharp surgical instruments to trim the mesh to ensure appropriate overlap of the defect on all sides. Reported standard of care is 5 cm or greater. If GORE SYNECOR Intraperitoneal Biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect. SUTURE FIXATION Nonabsorbable sutures, such as GORE TEX Suture, (such as taper or piercing point) of appropriate size 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. 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") from the edge of the device. Interrupted sutures can provide additional security against recurrence due to suture failure. 4.4

26 Instructions for use ADDITIONAL / ALTERNATIVE FIXATION Permanent staples or helical tacks (also known as helical coils) can be used as an alternative to sutures. Staple size and staple or tack spacing should be determined by surgeon preference to provide for adequate tissue fixation and to prevent reherniation. 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. Fixation methods other than those described above have not been evaluated for use with GORE SYNECOR Intraperitoneal Biomaterial. All fixation devices should be used in accordance with the manufacturer s instructions for use and the physician should reference the manufacturer s instructions for use and any supporting clinical literature regarding any potential adverse reactions related to fixation devices. WARNINGS Strict aseptic techniques should be followed. When operative infection is suspected, dissection of involved tissues should be considered. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. As with any mesh, use of GORE SYNECOR Intraperitoneal Biomaterial in contaminated fields may require removal of the mesh if infection occurs When using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary Incorrect positioning of the shiny film surface adjacent to fascial or subcutaneous tissue will result in minimal tissue attachment. Persistent seroma may result. Use of this product in applications other than those indicated has the potential for serious complications GORE SYNECOR Intraperitoneal Biomaterial has not been clinically evaluated in transvaginal pelvic prolapse repair. Clinical data has shown that use of any surgical mesh in transvaginal pelvic organ prolapse procedures could result in complications, including, but not limited to, mesh exposure, mesh erosion, pelvic pain, fistula formation, dyspareunia, infection, vaginal dysfunction or recurrence. PRECAUTIONS Use of GORE SYNECOR Intraperitoneal Biomaterial in infants, children or pregnancy where future growth will occur has not been evaluated Ensure the size of the mesh is adequate for the intended repair Do not use absorbable sutures to secure the mesh in place Appropriate force should be used when positioning tacking devices to avoid damage to film surface Do not resterilize the GORE SYNECOR Intraperitoneal Biomaterial ADVERSE REACTIONS Possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence. As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision / resurgery, device contraction, fever, hernia recurrence. 4.5

27 References

28 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: Giordano, S., Garvey, P. B., Baumann, D. P., Liu, J., & Butler, C. E. (2017). 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 161(2), 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): 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): 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): 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: Olson TB. Competitive Hernia Device Strength Evaluation. Flagstaff, AZ: W. L. Gore & Asoociates, Inc; [Work plan]. WP 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): Zhu LM, Schuster P, Klinge U.Mesh implants: an overview of crucial mesh parameters. World Journal of Gastrointestinal Surgery 2015; 7(10): 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: 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): 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): 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): Berman A. Evaluation of Plexus with film and ETHICON PHYSIOMESH in a 30-day rabbit intraperitoneal model. Flagstaff, AZ: W.L. Gore & Associates, Inc.; [Corporate protocol]. 2335SC. 15. Crawford N. Assessment of Vascularity via Micro CT in Various Patch Devices. Flagstaff, AZ: W. L. Gore & Associates, Inc.; [Final study report]. 2344TL. 16. Berman A. Evaluation of Plexus with film and ETHICON PHYSIOMESH in a 180-day rabbit intraperitoneal model. Flagstaff, AZ: W. L. Gore & Associates, Inc.; [Corporate protocol]. 2337SC. 17. Matthews BD, Mostafa G, Carbonell AM, Joels CS, Kercher KW, Austin C, Heniford BT. (2005). Evaluation of adhesion formation and host tissue reponse to intra-abdominal polytetrafluoroethylene mesh and composite prosthetic mesh. Journal of Surgical Research, 13(2), Clinger L. PTFE Knit Microbial Placement. Flagstaff, AZ; W. L. Gore & Associates, Inc; [Workplan]. WP Kim M, Oommen B, Ross SW, et al. The current status of biosynthetic mesh for ventral hernia repair. Surgical Technology International 2014;25: 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): 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): 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. 23. 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 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):

29 W. L. Gore & Associates, Inc. Flagstaff, AZ (Asia Pacific) (United States) (Europe) (United States) goremedical.com Refer to Instructions for Use for a complete description of all warnings, precautions, and contraindications. Products listed may not be available in all markets. ALLERGAN and STRATTICE are trademarks of Allergan, Inc. BARD, COMPOSIX, DULEX, SEPRAMESH, VENTRALIGHT, VENTRIO, and XENMATRIX are trademarks of C.R. Bard, Inc. DAVOL and PHASIX are trademarks of Davol, Inc., a subsidiary of C. R. Bard, Inc. COOK, BIODESIGN, and ZENAPRO are trademarks of Cook Medical. ETHICON, FLEXHD, and XCM BIOLOGIC are trademarks of Ethicon, Inc. INTEGRA and SURGIMEND are trademarks of Integra LifeSciences Corporation. KEBOMED and DYNAMESH are trademarks of KEBOMED. MAQUET and CQUR are trademarks of Maquet Getinge Group. MEDTRONIC, 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. GORE, BIO-A, SYNECOR, and designs are trademarks of W. L. Gore & Associates. 2016, 2018 W. L. Gore & Associates, Inc. AU2131-EN4 AUGUST 2018