www.fdanews.com/articles/174956-gore-medical-wins-clearance-for-biomaterial
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Gore Medical Wins Clearance for Biomaterial
January 19, 2016
Gore Medical has scored a victory at the FDA with 510(k) clearance for its GORE SYNECOR biomaterial designed for hernia repair.
While surgeons traditionally have had to choose between permanent and non-permanent materials, the device is composed of three materials — dense monofilament polytetrafluoroethylene macroporous knit, a tissue scaffold and a nonporous film — which allow surgeons to avoid compromising on materials, the company says.
Gore adds that the device provides for well vascularized ingrowth for use in open, laparoscopic and robotic cases. — Michael Cipriano