Gore received 510(k) clearance from the FDA to introduce its GORE SYNECOR Preperitoneal Biomaterial hernia repair device in the U.S. The material has both permanent and bioresorbable components and can be used in most hernia repair procedures, including for intraperitoneal and preperitoneal placement, and during traditional open, laparoscopic, or even robotic surgeries. It is designed to help treatment consist of only a single surgery and to help facilitate tissue in-growth following implantation.
Here’s some details from Gore about the structure of GORE SYNECOR:
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.
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.
Product page: GORE SYNECOR Biomaterial…
Via: Gore…