CE Mark for Gore’s Hybrid Vascular Graft Signals Preservation Of Dialysis Access Sites

In short

Arizona’s W. L. Gore & Associates has announced the gaining of CE Mark approval for its GORE® Hybrid Vascular Graft. According to the company the graft is designed to expand treatment options for optimal outflow by maximising the number of access sites available. Gore is also trumpeting twelve month follow-up data for newly created access implants which demonstrates a trend towards significant improvement in functional graft patency and reduction in seroma, as compared with historical graft data.

Background

The GORE Hybrid Vascular Graft is designed to address the most common causes of graft failure; intimal hyperplasia, thrombosis, and seroma. The device comprises the company’s signature expanded polytetrafluoroethylene (ePTFE) vascular prosthesis, a section of which is reinforced with nitinol and partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations.

Furthermore the company tells us 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.

The product received FDA clearance in 2010 and 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, procedures for which it has been used on more than 2500 patients since commercialisation.

The device simplifies access to vessels with an optional over the wire deployment method that reduces vessel injury and dissection. As a consequence GORE says its 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.

Clinician comments

“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.”

Company comments

“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, Business Wire