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news.W L Gore & Associates has received approval from the FDA to market the Gore Viabahn Endoprosthesis for use in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4-12mm.
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The iliac indication was obtained using data collected as part of the Gore Viabahn Endoprosthesis feasibility study that was conducted in the US and Europe from 1996 to 1999. Data collected from this study was used to establish the Gore Viabahn Endoprosthesis as safe and effective for treatment of iliac arterial occlusive disease when used in accordance with its labeling.
The Gore Viabahn Endoprosthesis was previously approved for use in patients with symptomatic peripheral artery disease in superficial femoral artery (SFA) lesions with reference vessel diameters ranging from 4–7.5mm.
The Gore Viabahn Endoprosthesis is a stent-graft and is said to be the only device of its kind on the market and approved for treating peripheral vascular disease in the SFA.