A Medical Device Daily
C. R. Bard (Murray Hill, New Jersey) said it has received pre-market approval (PMA) from the FDA to market its 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 (Tempe, Arizona).
According to Bard, two-year clinical data on the LifeStent demonstrated a freedom from target lesion revascularization rate of 78% vs. 42% for percutaneous transluminal angioplasty alone. In addition, the device exhibited a low fracture rate of 3.8% at 18 months, the company noted.
"The long-term data recently presented are important because they demonstrate the sustained performance of the LifeStent vascular stent," said Barry Katzen, MD, founder and medical director of Baptist Cardiac & Vascular Institute (Miami) and co-principal investigator of the LifeStent RESILIENT trial.
Of particular significance to clinicians and patients is the approval of the 170mm stent, the longest commercially available in the U.S., Katzen noted. "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," he said.
The LifeStent FlexStar and FlexStar XL were previously approved for blockage of the bile ducts.
Bard bought the LifeStent product line from Edwards Lifesciences (Irvine, California) early last year (Medical Device Daily, Jan. 15, 2008), a deal that was first disclosed in December 2007. In addition to paying Edwards about $74 million at the time of closing, the deal included up to an additional $65 million on the achievement of certain milestones, including FDA approval of LifeStent products for a SFA indication (MDD, Dec. 10, 2007). At the time of the acquisition, Edwards had already submitted a PMA application and was in the process of responding to the agency's questions.
"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 U.S.," Timothy Ring, CEO/chairman of Bard, said in a company statement "It's also the third PMA we have received for a peripheral vascular stent or stent-graft 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."
In December, the company reported FDA approval for its E*Luminexx vascular stent, a flexible, self-expanding nitnol stent intended to treat patients with common or external iliac artery occlusive disease (MDD, Dec. 10, 2008). That approval came soon after the agency approved Bard's Flair endovascular stent graft with an optimized delivery system. That device is comprised of a self-expanding Nitnol stent encapsulated within Bard's ePTFE graft material, and is indicated to treat stenoses in synthetic arteriovenous bypass grafts (MDD, Oct. 31, 2008).
After receiving FDA approval for the E*Luminexx stent and the Flair stent graft, Ring said in a company statement that the "anticipated approval of the LifeStent FlexStar stent for the treatment of [SFA] disease will further enhance our comprehensive offerings to address challenges associated with the treatment of peripheral vascular disease."