W.L. Gore & Associates said today it won FDA 510(k) clearance for its Synecor biomaterial designed for open, laparoscopic and robotic single-stage hernia repairs.
The Synecor biomaterial is comprised of dense monofilament polytetrafluoroethylene macroporous knit to provide strength and reduce bacteria growth, Gore’s Bio-A Web tissue scaffold and a non-porous PGA/TMC film to minimize tissue attachment at the visceral side, the company said.
“Hernia repair is one of the most common surgeries performed globally. We expect that this new composite material will make a positive impact on patient outcomes, providing value for surgeons, hospitals and patients,” general surgical products biz unit leader Ron Anderson said in a press release
Gore said the material will allow surgeons to get the benefits of both a permanent material and absorbable, non-permanent materials during hernia repairs.
While no certification is required to use the implant, Gore said it is providing operating room support and educational courses for surgeons interested in using the material.
This article originally appeared on MassDevice.com’s sister site, Medical Design & Outsourcing.
The post Gore wins 510(k) for Synecore hernia repair biomaterial appeared first on MassDevice.
from MassDevice http://ift.tt/1lsE3Io
Cap comentari:
Publica un comentari a l'entrada