Bard Receives FDA Approval For The FlairTM Endovascular Stent Graft

Main Category: Medical Devices / Diagnostics
Also Included In: Cardiovascular / Cardiology
Article Date: 30 Oct 2008 - 9:00 PDT

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C. R. Bard, Inc. (NYSE: BCR) today announced that it has received approval from the United States Food and Drug Administration to market the FlairTM Endovascular Stent Graft with an optimized delivery system. The device, comprised of a self-expanding Nitinol stent encapsulated within Bard's proprietary ePTFE graft material, is marketed by the Bard Peripheral Vascular Division located in Tempe, Arizona.

The FlairTM Endovascular Stent Graft is indicated to treat stenoses in synthetic arteriovenous bypass grafts. More than 300,000 patients with end-stage renal disease in the United States rely on these bypass grafts to receive hemodialysis treatment. These stenoses are the leading cause of bypass graft malfunction, compromising dialysis quality. Typically, multiple interventions, primarily with balloon angioplasty, are necessary to maintain the patency of bypass grafts over their useful lives.

Bard's six month, prospective, randomized, pivotal study of 190 patients at 16 sites showed that placement of the Flair™ Endovascular Stent Graft resulted in more than twice the primary patency of balloon angioplasty (50.6% vs. 23.3%, p<0.001). "The FlairTM Endovascular Stent Graft is the first interventional technology that has demonstrated superiority to balloon angioplasty for maintaining access patency," said Ziv Haskal M.D., Professor of Radiology at the University of Maryland and lead investigator of the clinical trial.

Timothy M. Ring, chairman and chief executive officer, commented, "This approval is the first in our developing position in the U.S. peripheral vascular stent market. We have two additional PMA applications pending. One for an iliac artery indication for our E-Luminexx™ Stent and another for a superficial femoral artery indication for our LifeStent® FlexStar Stent. With this pipeline, Bard is poised to have a broad and well-positioned peripheral vascular stent lineup in the U.S. market."

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. http://www.crbard.com

Source
Eric J. Shick, 908-277-8413
Vice President, Investor Relations
C. R. Bard, Inc
and
Holly P. Glass, 703-754-2848
Vice President, Government and Public Relations
C. R. Bard, Inc

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