Large Diameter GORE VIABAHN Endoprosthesis Has Heparin Bioactive Surface


July 22, 2009

The GORE VIABAHN Endoprosthesis, a self-expanding, covered, stent, is offered in diameters from 6-13 mm for the treatment of peripheral arterial disease (PAD) in the iliac artery.

It is deployed using a 0.035” guide wire and TIP to HUB direction. Additional modifications to the large diameter GORE VIABAHN Endoprosthesis (9-13 mm) include radial device expansion, a contoured proximal edge and a lower profile that is now available for most sizes.

The GORE VIABAHN Endoprosthesis family of devices is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The product’s flexibility enables it to traverse tortuous areas and to conform to the complex anatomy of the artery.

The FDA initially approved the original device configuration in 6-8 mm sizes in 2005 for treating PAD in the superficial femoral artery (SFA). The 9-13 mm sizes were released in July 2009. In 2007, Gore added a 5 mm size and made modifications to the device, including reducing its profile and adding a Heparin bioactive surface. In 2008, Gore received approval for large diameters of the GORE VIABAHN Endoprosthesis 9-13 mm for the indication of improving blood flow in patients with symptomatic peripheral artery disease in iliac artery lesions. In June 2009 the FDA allowed Gore to change the device by removing excess material at the device margin, resulting in a contoured edge at the proximal end. The device is the only stent-graft approved by the FDA for the treatment of patients suffering from PAD in superficial femoral and iliac artery lesions.

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