Bard Receives FDA Approval For The LifeStent(R) Vascular Stent

Main Category: Vascular
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Feb 2009 - 0:00 PDT

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C. R. Bard, Inc., (NYSE: BCR) announced that it has received Pre-Market Approval (PMA) 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, M.D., founder and medical director of Baptist Cardiac & Vascular Institute and co-principal investigator of the LifeStent® RESILIENT trial, commented, "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 M. Ring, chairman and chief executive officer, commented, "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. 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."

C. R. Bard, Inc., is a multinational developer, manufacturer, and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current expectations, the accuracy of which is necessarily subject to risks and uncertainties. These statements are not historical in nature and use words such as "anticipate", "estimate", "expect", "project", "intend", "forecast", "plan", "believe", and other words of similar meaning in connection with any discussion of future operating or financial performance. Many factors may cause actual results to differ materially from anticipated results including product developments, sales efforts, income tax matters, the outcomes of contingencies such as legal proceedings, and other economic, business, competitive and regulatory factors. The company undertakes no obligation to update its forward-looking statements. Please refer to the Cautionary Statement Regarding Forward-Looking Information in our September 30, 2008 Form 10-Q for more detailed information about these and other factors that may cause actual results to differ materially from those expressed or implied.

C. R. Bard, Inc.

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