Bard Receives FDA Approval for Endovascular Stent Graft
The FLAIR Endovascular Stent Graft treats stenoses (narrowing) at the venous anastomosis of synthetic arteriovenous (AV) grafts in hemodialysis patients to increase blood flow.
The FLAIR Endovascular Stent Graft is a flexible, self-expanding stent graft made of expanded ePTFE covering a Nitinol stent framework. Bard’s Peripheral Vascular Division is currently in discussions with the FDA on a post-approval study design utilizing a new FLAIR delivery system. The initial market launch for the FLAIR Endovascular Stent Graft is expected in late 2008, following FDA approval of the new FLAIR delivery system.
“The FLAIR Endovascular Stent Graft is the first interventional technology that has demonstrated superiority to balloon angioplasty for maintaining access patency,” said Ziv Haskal, M.D., of New York Presbyterian/Columbia University Medical Center.
Dr. Haskal was the lead investigator of the randomized, prospective, multicenter clinical trial to evaluate the safety and effectiveness of the device. Of the 190 patients with a hemodynamically significant stenosis, 50 percent at the synthetic AV access graft-vein-anastomosis were randomized for treatment with PTA, followed by the placement of a FLAIR Endovascular Stent Graft, or for treatment with PTA alone. |