W.L. Gore & Associates said today it won FDA 510(k) clearance for its Synecor preperitoneal biomaterial hernia repair device, with plans to launch the device this week.
The Synecor preperitoneal biomaterial is a hybrid biosynthetic hernia repair device designed for use in single-stage preperitoneal, onlay and retromuscular placements through open, laparoscopic and robotic procedures, the Flagstaff, Ariz.-based company said.
“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. 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,” Dr. William Cobb said in a press release.
The device is designed with 3 layers, including a macroporous knit of monofilament polytetrafluoroethylene fibers and 2 surrounding layers of Gore Bio-A web bioabsorbably copolymer scaffolds to facilitate tissue ingrowth and vascularization on both sides of the device, the company said.
“We tailored the PTFE material’s microstructure, porosity, and form to match this application, making this device distinct even among other hernia repair 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,” general medical products biz lead David Lane said in a press release.
Last month, Gore said it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region.