MURRAY HILL, N.J.--(BUSINESS WIRE)--Oct. 29, 2008--C. R. Bard,
Inc. (NYSE: BCR) today announced that it has received approval from
the United States Food and Drug Administration to market the Flair(TM)
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 Flair(TM) 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(TM)
Endovascular Stent Graft resulted in more than twice the primary
patency of balloon angioplasty (50.6% vs. 23.3%, p less than 0.001).
"The Flair(TM) 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
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(TM) Stent and another for a superficial femoral artery
indication for our LifeStent(R) 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. (www.crbard.com) is a multinational developer,
manufacturer, and marketer of innovative, life-enhancing medical
technologies in the fields of vascular, urology, oncology and surgical
CONTACT: C. R. Bard, Inc.
Eric J. Shick, 908-277-8413
Vice President, Investor Relations
Holly P. Glass, 703-754-2848
Vice President, Government and Public Relations
SOURCE: C. R. Bard, Inc.