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® Tissue Reinforcement, GORE® SYNECOR Preperitoneal and Intraperitoneal Biomaterial and GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement.
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
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