Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks...

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 ReinforcementA Valuable Alternative to Biologics

Refer to Instructions For Use at goremedical.com for a complete description of all warnings, precautions, and adverse events.


Clinical need

Additional support for tissue without increased risks associated with permanent materials1,2

What are the risks?• Erosion• Infection• Seroma• Wound dehiscence• Enterocutaneous fistulae

1Davis SS Jr. Current controversies in paraesophageal hernia repair. Surgical Clinics of North America 2008;88(5);959-978.2Bruening K, Butler CE, Ferzoco S, et al; The Ventral Hernia Working Group. incisional ventral hernias; review of the literatureand recommendations regarding the grading and technique of repair. Surgery 2010;148(3);544-558.


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


Managing the risk of complicationsin complex cases

In the example of incisional hernia repair, many cases are complex. As Breuing et al1

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

1Breuing 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):544-558.


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 generationand 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.


Tissue scaffold – Material Structure

1Photo 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 Gel1


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


Tissue Fills the scaffold

*Cells & Blood Vessels Make Up Remaining Volume

Calculated by Histological Image Analysis1Morales-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 Replacement1


Tissue scaffold –Rapid cell population and vascularization1

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.


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 reversalBreast

reconstruction using pedicled

TRAM flap


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


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


GORE® BIO-A® Tissue ReinforcementImages


Product Photos


Gore bioabsorbable clinical history

Products listed may not be available in all markets. GORE ®, BIO-A ®, and designs are trademarks...

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