W. L. Gore & Associates received CE Mark approval for its GORE Hybrid Vascular Graft in the European Union, a device for replacing or bypassing damaged vasculature due to aortic aneurysms, peripheral vascular and end stage renal disease.
The device has received FDA approval back in 2010 and has already been used in over 2500 procedures.
More about the graft from the announcement:
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.
You’ve got to love puns like “palpably bridges the gap” between vascular and endovascular surgery. When you read as many press releases as we do, it’s especially appreciated.
Press release: Gore Receives CE Mark for GORE® Hybrid Vascular Graft
Product page: GORE Hybrid Vascular Graft