MURRAY HILL, N.J.--(BUSINESS WIRE)--Feb. 17, 2009--
C. R. Bard, Inc., (NYSE: BCR) today 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., (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 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.
Source: C. R. Bard, Inc.
C. R. Bard, Inc. Investors: Eric J. Shick,
908-277-8413 Vice President, Investor Relations or Media: Holly
P. Glass, 703-754-2848 Vice President, Government and Public
Relations
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