C R Bard Inc has announced that it has received pre-market approval from the United States Food and Drug Administration to market the LifeStent FlexStar and FlexStar XL vascular stent systems. The devices are approved for the treatment of occlusive disease in native superficial femoral arteries (SFA) and proximal popliteal arteries, and are marketed by the Bard Peripheral Vascular Division, located in Tempe, Arizona.
Two-year clinical data on the LifeStent vascular stent demonstrated a freedom from target lesion revascularization rate of 78% vs. 42% (p<.0001) for percutaneous transluminal angioplasty alone.
In addition, the device exhibited a low fracture rate of 3.8% at 18 months. Dr Barry Katzen, founder and medical director of Baptist Cardiac & Vascular Institute and co-principal investigator of the LifeStent RESILIENT trial, said: “The long-term data recently presented are important because they demonstrate the sustained performance of the LifeStent vascular stent.
“Of particular significance to clinicians and patients is the approval of the 170mm stent, the longest commercially available in the United States. 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.”
Timothy Ring, chairman and chief executive officer, said: “The approval of the LifeStent vascular stent positions Bard as the only company offering a stent indicated for the treatment of SFA and proximal popliteal disease in the USA.
“It’s also the third pre-market approval we have received for a peripheral vascular stent or stentgraft in the last five months. This demonstrates our ability to execute rigorous clinical trials and our commitment to introducing innovative products to address the needs of clinicians and their patients.”