REGULATORY NEWS

FDA clears Bard vascular stent for femoral, popliteal arteries


C. R. Bard has received pre-market approval (PMA) from the FDA to market its LifeStent FlexStar and FlexStar XL vascular stent systems for the treatment of occlusive disease in native superficial femoral arteries (SFA) and proximal popliteal arteries.

Bard Peripheral Vascular Division in Tempe, Ariz., markets the devices.

Two-year clinical data on the LifeStent vascular stent demonstrated a freedom from target lesion revascularization rate of 78 vs. 42 percent for percutaneous transluminal angioplasty alone, according to the Murray Hill, N.J.-based C.R. Bard. In addition, the device exhibited a low fracture rate of 3.8 percent at 18 months.

"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," said Barry Katzen, MD, founder and medical director of Baptist Cardiac & Vascular Institute in Miami and co-principal investigator of the LifeStent RESILIENT trial.

Last updated on February 19, 2009 at 9:32 am EST