Gore gains EU approval for vascular graft

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W. L. Gore & Associates has received CE Mark for the Gore Hybrid Vascular Graft, which is designed to expand treatment options for outflow by maximizing the number of access sites available.

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.