Gore Gains CE Mark for Vascular Graft

W.L. Gore & Associates has received the 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. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. When small blood vessels are ruptured, blood plasma can seep out; inflammation caused by dying injured cells also contributes to the fluid.

Since commercialization of the device, there have been more than 2,500 successful implants of the Hybrid graft, according to Gore. Patients who have benefited include those suffering occlusive or aneurysmal diseases, trauma patients requiring vascular replacement, those needing dialysis access, and other vascular procedures.

The graft, which received 510(k) clearance from the U.S. Food and Drug Administration in 2010, is used 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 (thickening of the Tunica intima of a blood vessel as a complication of a reconstruction procedure or the removal of the inner arterial lining), thrombosis (local coagulation or blood clotting), and seroma. The device reportedly simplifies access to vessels with an option over the wire deployment method that reduces vessel injury and dissection. The graft also has been used to create new access sites in anatomical locations that would otherwise have 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, M.D., assistant professor at the Methodist DeBakey Heart and Vascular Center in Houston, Texas. “The [device] allows the surgeon to create a sutureless anastomosis [surgical connection between vessels] and displays significant potential for improving hemodynamics.”

The graft uses several other Gore technologies such as the expanded polytetrafluoroethylene (commonly known as ePTFE) vascular prosthesis with a section reinforced by nitinol. The nitinol section is partially constrained, designed to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations.

The combination graft incorporates Carmeda Bioactive Surface (CBAS Surface) with covalently bonded heparin, which Gore claims results in a proven thrombo-resistant surface. The CBAS Surface is manufactured by medical coating company Carmeda AB (a wholly owned subsidiary of Gore), and is used by several companies as a blood compatible device coating.

Based in Flagstaff, Ariz., the Gore Medical Products Division’s portfolio includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery.