Gore Hybrid Vascular Graft Approved in Europe
August 20, 2012—Gore & Associates (Flagstaff, AZ) announced that it has received CE Mark approval for the Gore hybrid vascular graft, which is designed to expand treatment options for optimal outflow by maximizing the number of access sites available.
In 2010, the Gore hybrid vascular graft received clearance from the US Food and Drug Administration. It is indicated for use as a vascular prosthesis for replacement or bypass of diseased vessels affected by aortic aneurysmal, peripheral vascular, and end-stage renal disease. The device is designed to address the most common causes of graft failure: intimal hyperplasia, thrombosis, and seroma.
According to the company’s announcement, the device is composed of Gore’s expanded polytetrafluoroethylene vascular prosthesis, which has a nitinol-reinforced section that is partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations. The graft incorporates the Carmeda bioactive surface with covalently bonded heparin, resulting in a proven thromboresistant surface. The device simplifies access to vessels using an optional over-the-wire deployment method that reduces vessel injury and dissection. It has been used to create new access sites in anatomical locations that would have otherwise been abandoned, preserving the amount of access sites available throughout the patient’s long-term therapy.
“The Gore hybrid vascular graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery,” commented Jean Bismuth, MD, in the company’s press release. Dr. Bismuth is with the Methodist DeBakey Heart and Vascular Center in Houston, Texas. “It is the first significant innovation in vascular grafts in years, providing tremendous versatility. The Gore hybrid vascular graft allows the surgeon to create a sutureless anastomosis and displays significant potential for improving hemodynamics.”