Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 GORE ® BIO-A ® Tissue Reinforcement A Valuable Alternative to Biologics Refer to Instructions For Use at goremedical.com for a complete description of all warnings, precautions, and adverse events.

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Clinical need Additional support for tissue without increased risks associated with permanent materials 1,2 What are the risks? Erosion Infection Seroma Wound dehiscence Enterocutaneous fistulae 1 Davis SS Jr. Current controversies in paraesophageal hernia repair. Surgical Clinics of North America 2008;88(5); Bruening K, Butler CE, Ferzoco S, et al; The Ventral Hernia Working Group. incisional ventral hernias; review of the literature and recommendations regarding the grading and technique of repair. Surgery 2010;148(3);

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 solution Reinforcement material that functions as a scaffold for patient’s own cells to create tissue and replace material over time, leaving no permanent mesh behind. Two options: Harvest human or animal tissue and remove cells to leave scaffold behind –Biologics NEW ALTERNATIVE: Create synthetic tissue scaffold –Bioabsorbable web

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Managing the risk of complications in complex cases In the example of incisional hernia repair, many cases are complex. As Breuing et al 1 states, numerous influences that vary from patient to patient increase the risk of complications such as infections, seroma, wound dehiscence, formation of enterocutaneous fistulae and recurrence, as depicted below. Risk Assessment Low risk of complications No history of wound infections Co-morbid Smoker Obese Diabetic Immunosuppressed COPD Potentially Contaminated Previous wound infection Stoma present Violation of the gastrointestinal tract Infected Infected mesh Septic dehiscence 1 Breuing K, Butler CE, Ferzoco S, et al; The Ventral Hernia Working Group. Incisional ventral hernais: review of the literature and recommendations regarding the grading and technique of repair. Surgery 2010;148(3):

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Bioabsorbable scaffold designed to facilitate tissue generation Uniquely designed web of bioabsorbable polymers 67% PGA : 33% TMC – Same polymer as Maxon™ Suture Highly interconnected pores Degrades primarily by hydrolysis 3D matrix facilitates tissue generation and healing Cells infiltrate and form vascularized soft tissue Scaffold is absorbed in approximately six months Maxon is a trademark of Covidien AG or its affiliates.

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Tissue scaffold – Material Structure 1 Photo courtesy of Biophysical Society and Christopher B. Raub, Vinod Suresh, Tatiana Krasieva, Julia Lyubovitsky, Justin D. Mih, Andrew J. Putnam, Bruce J. Tromberg, and Steven C. George—University of California Irvine GORE ® BIO-A ® Tissue Reinforcement SEM (100x) GORE ® BIO-A ® Tissue Reinforcement SEM (50x) 3D Matrix with Highly Interconnected Pores Bioabsorbable web structure similar to a collagen fiber network Collagen Gel 1

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Gore bioabsorbable technology 3D bioabsorbable scaffold implanted Cells migrate into scaffold Cells secrete collagen to create new tissue Material absorbs and cells fill space with new tissue

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Tissue Fills the scaffold *Cells & Blood Vessels Make Up Remaining Volume Calculated by Histological Image Analysis 1 Morales-Conde S, Flores M, Fernandez V, Morales-Mendez 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. Volume of Material = Volume of Tissue: 1:1 Replacement 1

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Tissue scaffold – Rapid cell population and vascularization 1 3 Days: 7 Days: 14 Days:30 Days: As early as three days, the material is firmly embedded into native tissue (arrow). Cellular infiltration is present with lymphocytes, macrophages and erythrocytes. As wound healing progresses, strands of collagen and capillary proliferation (arrows) are evident. Dense fibrocollagenous tissue forms an early cellular scaffold as the material starts to absorb. Blood vessels are present between the material fibers. Native tissue is seamlessly incorporated within the GORE ® BIO- A ® Material. 1 Milligan’s Trichrome 20x. Histology of abdominal wall explant in rabbit. Data on file.

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Versatile for numerous applications Onlay of GORE ® BIO-A ® Tissue Reinforcement following primary closure of cura Suture line reinforcement with GORE ® BIO-A ® Tissue Reinforcement following midline closure Reinforcement of the pelvic floor with GORE ® BIO-A ® Tissue Reinforcement following primary closure GORE ® BIO-A ® Tissue Reinforcement placed between anterior sheath and rectus muscle prior to primary closure of anterior sheath Reinforcement of suture line with GORE ® BIO-A ® Tissue Reinforcement at rectus muscle donor site Paraesophageal/hiatal hernia repair Abdominal wall reconstruction Abdominoperineal resection Stoma reversal Breast reconstruction using pedicled TRAM flap

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 A new alternative to expensive biologics GORE ® BIO-A ® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. Example applications where this product may be used include, but are not limited to: Hernia repair (non-load bearing applications) Muscle flap reinforcement General tissue reconstructions

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Conclusion Non-permanent tissue scaffolds play an important clinical role Biologics (decellularized tissue) are not the only technology to provide tissue scaffolds Gore bioabsorbable web technology creates tissue scaffold without disadvantages of permanent materials or biologics

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 GORE ® BIO-A ® Tissue Reinforcement Images

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Product Photos

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Product Photos

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks of W. L. Gore & Associates. © 2010 W.L. Gore & Associates, Inc. AP6305-EN1 NOVEMBER 2010 Gore bioabsorbable clinical history