Thursday, July 2, 2009
Smoother GORE VIABAHN Endoprosthesis Gets Approved in US
Filed under: Vascular Surgery
W. L. Gore & Associates just received FDA's OK to market an updated version of the firm's GORE VIABAHN® Endoprosthesis indicated for "improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference diameters ranging from 4.0 - 7.5 mm [and] in iliac artery lesions with reference vessel diameters from 4.0 – 12 mm"
The modification is a result of the precision laser trimming technology which enables the removal of excess material at the device margin, resulting in a contoured edge. The device is the only stent-graft approved by the FDA for the treatment of patients suffering from Peripheral Arterial Disease (PAD) in superficial femoral artery (SFA) lesions and iliac artery lesions. In the US alone, as many as 12 million people suffer from PAD.The GORE VIABAHN Endoprosthesis is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The outstanding flexibility of the GORE VIABAHN Endoprothesis enables it to traverse tortuous areas of the SFA and to conform to the complex anatomy of the artery. The device was initially approved by the FDA in 2005 for treating PAD in the SFA. Later in 2007, Gore made modifications to the device which includes reducing the profile and adding a Heparin Bioactive Surface.
Product page: GORE VIABAHN® Endoprosthesis
Press release: Gore Receives FDA Approval for Modification of GORE VIABAHN® Endoprosthesis
Flashbacks Gore VIABAHN® Endroprosthesis Stent: Now Approved...
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