FDA Clears W. L. Gore & Associates’s GORE SYNECOR Preperitoneal Biomaterial Hernia Repair Device

Hybrid of unique bioabsorbable and permanent materials provide a single-stage hernia repair to help minimize complications in preperitoneal applications

FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its GORE® SYNECOR Preperitoneal Biomaterial hernia repair device. The device is being launched June 8 at the Abdominal Wall Reconstruction (AWR) Conference in Washington, D.C. The Gore SYNECOR portfolio now offers treatment options for the full range of hernia cases, with configurations for both intraperitoneal and preperitoneal placement.

“We tailored the PTFE material’s microstructure, porosity, and form to match this application, making this device distinct even among other hernia repair products”

“The hybrid of a permanent synthetic mesh with a long-term bioabsorbable in the GORE® SYNECOR Preperitoneal Biomaterial is an innovative solution for preperitoneal hernia repairs, where the device’s placement between tissue layers makes tissue ingrowth especially desirable,” said William S. Cobb IV, MD, FACS.

GORE SYNECOR Preperitoneal Biomaterial is a hybrid, biosynthetic hernia repair solution intended for single-stage preperitoneal, onlay, and retromuscular placements through open, laparoscopic, and robotic applications. It is comprised of three layers: A macroporous knit of dense, monofilament polytetrafluoroethylene (PTFE) fibers provides strength for a durable single-stage repair and minimizes harboring of bacteria, while two surrounding layers of GORE® BIO-A® Web, a bioabsorbable copolymer scaffold, facilitate tissue ingrowth and vascularization on both sides of the device. Some common applications include: Transversus abdominis release (TAR) procedure, component separation technique, preperitoneal ventral hernia repair, and high-risk ventral hernia repair.

“I see immense value in the potential of this product to provide a single surgery that offers fast recovery, minimizes remaining material, and may reduce complications, such as mesh splitting and infection, when compared to the multi-surgery staged repairs required in some complex cases,” said Dr. Cobb.

GORE BIO-A Web scaffold has a 20-year history of clinical use as a cost-effective and efficient reinforcement for soft-tissue. Studies have shown that GORE BIO-A Web facilitates rapid vascularity that supports generating quality tissue fast. The web scaffold provides a 3-D matrix of interconnected pores that fills quickly with collagen and facilitates a 1:1 tissue generation within the thickness of the material, with complete absorption by the body in approximately six months. In addition, studies have shown that hernia repairs with the biosynthetic scaffold have low long-term hernia recurrence rates with improved quality of life for patients.

Preclinical studies of GORE SYNECOR Preperitoneal Biomaterial demonstrated that the tissue-building scaffold promoted vascularity within seven days and tissue ingrowth within one month. Vascularity within the device and the PTFE fiber design enable treatment options in the presence of contamination, minimizing the need for device removal.

“We tailored the PTFE material’s microstructure, porosity, and form to match this application, making this device distinct even among other hernia repair products,” said David Lane, Business Leader for General Medical Products. “In hernia surgery, total cost of care can vary widely if complications occur, which is why we used a unique combination of high-quality materials to reduce the potential for most common complications. Additionally a biosynthetic product like GORE SYNECOR Preperitoneal Biomaterial can be less than half the cost of commonly used biologic meshes and can be used in place of biologic and permanent, synthetic meshes in clean and clean high-risk patient types, overall providing strong clinical and economic value to providers.”

The GORE® SYNECOR Product portfolio of hernia repair solutions also includes GORE® SYNECOR Intraperitoneal Biomaterial, which is being evaluated through an ongoing Clinical Quality Improvement (CQI) Study designed to evaluate the real-world use of the device without exclusion criteria.

An update on the CQI Study will also be featured at AWR in two sessions that are open to the public:

• Lunch Symposium – June 9 from 1:20 -2:00 pm EDT in the General Session Room (Grand Ballroom)
• Reception with Interactive Displays – June 9 from 6:30 -8:00 pm EDT in Salon 1 (Gore Pavilion)

MEDICAL PRODUCTS DIVISION

Gore Medical Products Division 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 W. L. GORE & ASSOCIATES

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 continued recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs approximately 10,000 Associates and generates annual revenues that exceed $3 billion. www.gore.com

Products listed may not be available in all markets. GORE®, BIO-A®, SYNECOR, and designs are trademarks of W. L. Gore & Associates. AWO776-EN1 JUNE 2017