Published on 22 August 2012
Gore gains EU approval for vascular graft
The Gore Hybrid Vascular Graft, which received FDA clearance in 2010, is indicated for use as a vascular prosthesis for replacement or bypass of diseased vessels impacted by aortic aneurysmal, peripheral vascular and end-stage renal disease, according to the Flagstaff, Ariz.-based company. The device is designed to address the causes of graft failure; intimal hyperplasia, thrombosis and seroma.
The expanded polytetrafluoroethylene vascular prosthesis has a section reinforced with nitinol that is partially constrained. It is the only combination graft of its kind that incorporates Carmeda BioActive Surface with covalently bonded heparin, resulting in a thrombo-resistant surface.