News | January 09, 2015

Gore Receives CE Mark Approval for Gore Viabahn Endoprosthesis

Gore Medical, Gore Viabahn Endoprosthesis, CE Mark, stent grafts

January 9, 2015 — W. L. Gore & Associates Inc. announced that the Gore Viabahn Endoprosthesis has received CE Mark approval to improve blood flow in symptomatic obstruction of peripheral veins, excluding the venae cavae and pulmonary veins.

“The Gore Viabahn Endoprosthesis is a welcome addition to options available for treating stenosis in the dialysis access circuit,” said Peter Riley, M.D., consultant interventional radiologist at the Queen Elizabeth Hospital Birmingham, United Kingdom. “It has a proven track record in maintaining patency in central chest vein stenosis as confirmed by our recently published single-center study. It is extremely flexible, allowing deployment across anatomical sites of movement and flexion. The Gore REVISE Clinical Study indicates improved patency compared to PTA [percutaneous transluminal angioplasty] in the graft to vein anastamosis and has demonstrated similar outcomes to draining veins, particularly at the cephalic arch, in my practice.”

In the Gore REVISE Clinical Study (AVR 06-01), the Gore Viabahn device group demonstrated statistical superiority of target lesion primary patency as compared to PTA (p = 0.008).

The device is a low-profile, flexible, self-expanding, small-diameter, endoprosthesis constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner and attached to an external nitinol stent structure. The ePTFE luminal surface incorporates the CBAS Heparin Surface. This heparin technology consists of a covalent end-point attachment to the graft surface that is intended to provide sustained thromboresistance.

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