Gore receives CE mark for Gore Viabahn Endoprosthesis

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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] has a proven track record in maintaining patency in central chest vein stenosis as confirmed by our recently published single-centre 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 in the graft to vein anastomosis and has demonstrated similar outcomes to draining veins, particularly at the cephalic arch, in my practice,” says Peter Riley, consultant interventional radiologist at the Queen Elizabeth Hospital, Birmingham, UK.

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).

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

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