GORE ENFORM Biomaterial offers unprecedented conformability

and facilitates highly-vascularized, uniform tissue ingrowth

FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W.

L. Gore & Associates, Inc. (Gore) will showcase its new GORE®

ENFORM Biomaterial, a fully synthetic and absorbable biomaterial

designed for optimal handling and tissue response, at the AHS annual

meeting in Las Vegas on March 11-14, 2019. Recently granted FDA

clearance and launched in the U.S., GORE ENFORM Biomaterial is used for

soft tissue reinforcement in abdominal wall reconstruction procedures

which includes use in plastic and reconstructive surgery procedures,

hernia repair, and muscle flap procedures. The device facilitates highly

vascularized uniform tissue ingrowth for critical healing and quality

soft tissue reconstruction outcomes, making it an exceptional

alternative to biologics.

Matthew Goldblatt, MD, general surgeon at Medical College of Wisconsin,

commented, “I’m especially impressed with the conformability and soft

flexible feel of the GORE ENFORM Biomaterial. It’s easy to handle and

implant. Additionally, this device has several features that make it

attractive. First, patients like that it’s fully bioabsorbable,

providing needed reinforcement and strength during critical healing and

then disappearing completely, leaving no permanent mesh behind. Second,

my OR staff appreciates that since it is not derived from human or

animal tissue, it does not require refrigeration, has no tissue tracking

requirements, and has a three-year shelf life.”

This distinctively soft and conformable device for abdominal wall

reconstruction resulted from Gore’s patient-focused collaboration with

plastic, general, and trauma surgeons. The device is composed of

synthetic bioabsorbable polyglycolic acid and trimethylene carbonate

copolymer, allowing it to be completely absorbed within six to seven

months, leaving no permanent material behind in the body.

Devinder Singh, MD, chief and medical director of Plastic Surgery at

Anne Arundel Medical Center in Annapolis, Maryland, added, “As a plastic

surgeon, the GORE ENFORM Biomaterial’s conformability, absorbability,

and handling make it ideal for complex soft tissue reconstruction

procedures in my patients. The engineering allows this device to better

match patient anatomy, which is crucial to ensuring both patient comfort

and improved patient satisfaction with the aesthetic outcome. I’m

impressed that the material is uniquely flexible while at the same time

promoting immediate infiltration to regenerate high-quality uniform

tissue. It is remarkable to see both features in the same product.”

“Gore did not just imagine a better future for abdominal wall

reconstruction. We engineered it,” said Todd Olson, Product Specialist,

W. L. Gore & Associates, Inc. “Not only have we developed a product that

works with the body’s natural healing process for a predictable result,

we are striving to provide considerable economic value by eliminating

tissue processing costs associated with biologics in complex

applications.”

Common applications for this device include ventral hernia repair as a

suture line reinforcement and donor site reinforcement for flap

procedures including deep inferior epigastric perforator (DIEP) and

transverse rectus abdominis muscle (TRAM). The GORE ENFORM Biomaterial

is part of Gore’s portfolio of surgical devices that feature the

company’s proven synthetic bioabsorbable material, including GORE® BIO-A®

Biomaterial and GORE®

Gore is dedicated to tracking the safety and efficacy of its products in

post-market clinical studies. A U.S. clinical study to track the

real-world, on-label indication use of the GORE ENFORM Biomaterial will

begin in 2019. The results will complement the over 10 years of clinical

data that is already available for the GORE BIO-A Tissue Reinforcement,

which is composed of the same polyglycolic acid (PGA) and trimethylene

carbonate (TMC) copolymer.

Gore Medical will also be hosting a lunch symposium at AHS on Tuesday,

March 12, from 12:30 p.m. to 1:30 p.m. in the Joshua 3-4 room.

For more information visit goremedical.com/products/enform.

For complete indications and other important safety information for

Gore commercial products referenced herein, refer to the applicable

Instructions for Use (IFU).

Medical Products Division

Gore engineers devices that treat a range of cardiovascular and other

health conditions. With more than 40 million medical devices implanted

over the course of more than 40 years, Gore builds on its legacy of

improving patient outcomes through research, education and quality

initiatives. Product performance, ease of use and quality of service

provide sustainable cost savings for physicians, hospitals and insurers.

Gore is joined in service with clinicians and through this collaboration

we are improving lives. www.goremedical.com

About Gore

W. L. Gore & Associates is a global materials science company dedicated

to transforming industries and improving lives. Founded in 1958, Gore

has built a reputation for solving complex technical challenges in the

most demanding environments — from revolutionizing the outerwear

industry with GORE-TEX® fabric to creating medical devices

that improve and save lives to enabling new levels of performance in the

aerospace, pharmaceutical and mobile electronics markets, among other

industries. The company is also known for its strong, team-oriented

culture and global recognition from the Great Place to Work®

Institute. Headquartered in Newark, Del., Gore employs 9,500 Associates

and generates annual revenues of $3.5 billion. www.gore.com

Products listed may not be available in all markets.

GORE®,

ENFORM, BIO-A®, and SEAMGUARD® are trademarks of W. L. Gore & Associates.

AX0878-EN1

MARCH 2019

Contacts

Media:

Bliss Integrated

Communication for Gore Medical

Liz DeForest

212-584-5477