Lutonix® Global Real-World Registry Outcomes Presented at TCT 2015
October 12 2015 - 7:30PM
Business Wire
C. R. Bard, Inc. (NYSE:BCR) announced today the presentation of
the 12-month results from the Lutonix® Global Real-World Registry
at the Transcatheter Cardiovascular Therapeutics (TCT) 2015
meeting. These results come just months after publication in the
New England Journal of Medicine of the 1-year data from the
Lutonix® 035 Drug Coated Balloon (DCB) Catheter pivotal, randomized
LEVANT 2 trial.
In this registry study, the Lutonix® 035 DCB demonstrated a
freedom from target lesion revascularization (TLR) rate of 94.3% in
femoropopliteal arteries at 12 months in 631 patients and, based
upon interim data from 170 patients (who were early enrollees), a
freedom from TLR rate of 93.0% at 24 months.
Professor Dierk Scheinert, Head of Department Interventional
Angiology at the University of Leipzig in Germany, commented, “The
final 12 month results of the Lutonix Global Registry demonstrated
how real world PAD patients with complex and long lesions can
benefit from this DCB technology without leaving metal behind. Also
encouraging are the interim 24 month results which suggest durable
benefits of the Lutonix DCB.”
Timothy M. Ring, chairman and chief executive officer,
commented, “I would like to thank all of the investigators who
participated in the Lutonix® Global Registry, which continues to
generate strong real-world evidence, providing clinicians with an
effective alternative to treat their patients who have PAD in
femoropopliteal arteries.”
Globally, nearly 202 million patients suffer from PAD, which if
untreated could lead to serious complications or even death.
According to the American Heart Association, PAD affects nearly 8
million Americans with more than 50 percent of cases involving the
femoropopliteal arteries in the legs. Patients with femoropopliteal
PAD have reduced blood flow to their lower extremities due to
narrowed arteries and carry the risk of amputations, a cause of
significant physical and psychological burden to patients and
substantial costs to the healthcare system.
About the Lutonix® DCB:
The Lutonix® 035 DCB is an angioplasty balloon coated with a
therapeutic dose of the drug Paclitaxel, which utilizes standard
mechanical dilatation to restore blood flow for patients with de
novo or restenotic lesions of up to 150mm in length in native
superficial femoral or popliteal arteries.
C. R. Bard, Inc. (www.crbard.com),
headquartered in Murray Hill, N.J., is a leading 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 June 30, 2015 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20151012006142/en/
C. R. Bard, Inc.Investor Relations:Todd W.
Garner, 908-277-8065Vice President, Investor
RelationsorMedia Relations:Scott T. Lowry,
908-277-8365Vice President and Treasurer
Bard C R (NYSE:BCR)
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