LifeStent FlexStar and FlexStar XL Vascular Stent

PMA Applicant : Bard Peripheral Vascular, Inc.
Address : 1625 W. 3rd Street, Tempe, AZ 85281
Approval Date : February 13, 2009

The LifeStent FlexStar and FlexStar XL Vascular Stent Systems are used to re-open stenotic (narrowed) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. They consist of two components, the stent and the delivery system. The stent is an implant constructed of nitinol (nickel-titanium alloy) tubing, laser-cut into a mesh shape. The stent is mounted within the delivery catheter: a long, thin, tube-like device.The inside lining of the artery will grow over the stent approximately 8 weeks after it is implanted. Once in place, the stent acts as a scaffold to Hold open the narrowed superficial femoral or proximal popliteal artery, and Improve blood flow to the legs.

Visit: http://www.fda.gov/cdrh/mda/docs/P070014.html