August 17, 2007 – C. R. Bard Inc. announced that it has received FDA approval to market its FLAIR Endovascular Stent Graft to treat 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, located in Tempe, AZ, 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, multi-center clinical trial to evaluate the safety and effectiveness of the device. One hundred 90 patients with a hemodynamically significant stenosis; 50% at the synthetic AV access graft-vein-anastomosis were randomized to treatment with PTA, followed by the placement of a FLAIR Endovascular Stent Graft, or to treatment with PTA alone.
Results of the clinical trial demonstrated that the FLAIR Endovascular Stent Graft was superior to the PTA Control with respect to the primary effectiveness endpoint, six month Treatment Area Primary Patency (51% vs 23%; p
For more information: www.crbard.com