The Flair endovascular stent graft, comprised of a self-expanding nitinol stent encapsulated within Bard’s proprietary ePTFE graft material, is marketed by the Bard Peripheral Vascular division located in Tempe, Arizona. The device is indicated to treat stenoses in synthetic arteriovenous bypass grafts.
Previously, Bard’s six month, prospective, randomized, pivotal study of 190 patients at 16 sites showed that placement of the Flair endovascular stent graft resulted in more than twice the primary patency of balloon angioplasty (50.6% versus 23.3%, p<0.001). Timothy Ring, chairman and CEO of Bard, commented, "This approval is the first in our developing position in the US peripheral vascular stent market. We have two additional premarket approval applications pending. "One for an iliac artery indication for our E Luminexx stent and another for a superficial femoral artery indication for our LifeStent FlexStar stent. With this pipeline, Bard is poised to have a broad and well-positioned peripheral vascular stent lineup in the US market."