Gore has received CE mark for its Gore Hybrid Vascular Graft which is indicated for use as a vascular prosthesis for replacement or bypass of diseased vessels impacted by aortic aneurysm, peripheral vascular and end stage renal disease.
The graft, which received FDA clearance in 2010, 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.
According to a company release, since commercialisation, 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, 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, assistant professor at the Methodist DeBakey Heart and Vascular Center in Houston, Texas, USA. “The graft allows the surgeon to create a sutureless anastomosis and displays significant potential for improving haemodynamics.”
About the Gore Hybrid Vascular Graft
The Gore Hybrid Vascular Graft is an expanded polytetrafluoroethylene (ePTFE) vascular prosthesis that has a section reinforced with nitinol. The nitinol reinforced section is partially constrained to allow for easy insertion and deployment into a vessel. The graft has a continuous lumen with the Carmeda BioActive Surface (CBAS Surface) consisting of a stable covalently bonded, reduced molecular weight heparin of porcine origin.