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