Large-Diameter Gore Viabahn Approved to Treat Iliac Arteries
July 21, 2009—W. L. Gore & Associates (Flagstaff, AZ) announced that it has received approval from the US Food and Drug Administration (FDA) to market the latest design for the Gore Viabahn endoprosthesis with heparin bioactive surface for device diameters of 9 to 13 mm for the treatment of peripheral arterial disease (PAD) in the iliac artery. The product enables streamlined deployment on the same 0.035-inch guidewire and tip-to-hub direction as the 5- to 8-mm sizes. Additional modifications to the large-diameter Viabahn include radial device expansion, a contoured proximal edge, and a lower profile that is now available for most sizes.
According to Gore, the Viabahn family of endoprosthesis devices features a durable, reinforced, biocompatible, expanded polytetrafluoroethylene liner attached to an external nitinol stent structure. In 2005, the FDA approved the original device configuration of 6- to 8-mm sizes for treating PAD in the superficial femoral artery.
In 2007, the company added a 5-mm size, reduced its profile, and added a heparin bioactive surface. In 2008, 9- to 13-mm sizes were approved for improving blood flow in patients with symptomatic PAD in iliac artery lesions. In June 2009, the FDA approved a manufacturing change to the device to remove excess material at the device margin, resulting in a contoured edge at the proximal end. The Viabahn's flexibility enables it to traverse tortuous areas and to conform to the complex anatomy of the artery, the company stated.
"The latest improvements to the Gore Viabahn, including a smaller delivery profile and 0.035-inch guidewire compatibility for the larger diameter endografts, will allow us to easily deliver the larger devices to more locations," commented Michael B. Silva Jr, MD. "Treating difficult vascular problems requires good skills and good equipment. The self-expanding, covered Viabahn offers elegant and versatile endovascular solutions to difficult vascular problems."