February 19, 2009 - C. R. Bard Inc. this week said it received pre-market approval (PMA) from the FDA to market the LifeStent FlexStar and FlexStar XL Vascular Stent Systems, which are approved for the treatment of occlusive disease in native superficial femoral arteries (SFA) and proximal popliteal arteries.
Two-year clinical data on the LifeStent vascular stent demonstrated a freedom from target lesion revascularization rate of 78 percent vs. 42 percent (p<.0001) for percutaneous transluminal angioplasty alone. In addition, the device exhibited a low fracture rate of 3.8 percent at 18 months.
“The long-term data recently presented are important because they demonstrate the sustained performance of the LifeStent vascular stent,” said Dr. Barry Katzen, M.D., founder and medical director of Baptist Cardiac and Vascular Institute and co-principal investigator of the LifeStent RESILIENT trial. “Of particular significance to clinicians and patients is the approval of the 170 mm stent, the longest commercially available in the U.S. Henceforth, long and diffuse lesions presenting in the SFA can be effectively treated with a single stent, which should help improve both clinical outcomes and procedural costs.”
Bard said approval of the LifeStent positions it as the only company offering a stent indicated for the treatment of SFA and proximal popliteal disease in the U.S.
For more information: www.crbard.com