GORE Hybrid Vascular Graft receives CE Mark approval

W. L. Gore & Associates (Gore) has received CE Mark for the GORE® Hybrid Vascular Graft. The graft is designed to expand treatment options for optimal outflow by maximizing the number of access sites available. Twelve month follow-up data for newly created access implants demonstrates a trend towards significant improvement in functional graft patency and reduction in seroma, as compared to historical graft data. Since commercialization, there have been more than 2500 successful implants of the GORE Hybrid Vascular Graft in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, and other vascular procedures.    

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. The device is designed to address the most common causes of graft failure; intimal hyperplasia, thrombosis, and seroma. The device simplifies access to vessels with an optional over the wire deployment method that reduces vessel injury and dissection. The GORE Hybrid Vascular Graft 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. It is the first significant innovation in vascular grafts in years, providing tremendous versatility," said Jean Bismuth, MD, Assistant Professor at the Methodist DeBakey Heart and Vascular Center in Houston, Texas. "The GORE Hybrid Vascular Graft allows the surgeon to create a sutureless anastomosis and displays significant potential for improving hemodynamics."

The GORE Hybrid Vascular Graft combines several trusted Gore technologies. The expanded polytetrafluoroethylene (ePTFE) vascular prosthesis has a section reinforced with nitinol. The nitinol reinforced section is partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations. It is the only combination graft of its kind that incorporates CARMEDA^® BioActive Surface (CBAS^® Surface) with covalently bonded heparin, resulting in a proven thromboresistant surface.

"Receiving CE Mark for the GORE Hybrid Vascular Graft demonstrates our commitment to providing physicians with innovative technology that can expand treatment options and improve patient outcomes worldwide," said Chuck Biggerstaff, associate with the Gore Venous Access Business.

Source: W. L. GORE & ASSOCIATES