LUTONIX® Global Real-World Registry 24-Month Outcomes Presented at VIVA 2016
September 22 2016 - 8:30AM
Business Wire
C. R. Bard, Inc. (NYSE:BCR) announced the presentation of the
final 24-month results from the LUTONIX® Global Real-World Registry
at the Vascular Intervention Advances (VIVA) 2016 Meeting. These
results are the first reported final 24-month outcomes for
“real-word” registry data for Drug Coated Balloon PTA Catheters
(DCBs). The registry includes a subgroup of patients with long
femoropopliteal lesions (>140mm) treated with the LUTONIX® 035
DCB. A Premarket Approval Supplement for use in this subgroup
population is currently under review with the U.S. Food and Drug
Administration.
In this registry study, the LUTONIX® 035 DCB demonstrated a
Freedom from Target Lesion Revascularization (TLR) at 24 months by
Kaplan-Meier time-to-event analysis of 90.3% for the overall study
population of 527 patients and 89.4% for the long lesion
(>140mm) subgroup of 106 patients.
Dr. James Benenati, Medical Director of the Peripheral Vascular
Laboratory at Miami Cardiac & Vascular Institute commented,
“These 24 month outcomes show the therapeutic durability and safety
of the LUTONIX® DCB in challenging ‘real world’ patients
with complex femoropopliteal artery lesions.”
Timothy M. Ring, chairman and chief executive officer,
commented, “The LUTONIX® Global Registry continues to generate
strong real-world evidence, confirming the sustained effectiveness
of the LUTONIX® DCB, which provides clinicians with an alternative
to treat patients who have peripheral artery disease (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® 035 Drug Coated Balloon PTA Catheter:
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. In the U.S., use of the
LUTONIX® 035 DCB in femoropopliteal lesions longer than 150mm is
limited by U.S. law to investigational use.
C. R. Bard, Inc. (www.crbard.com), headquartered in
Murray Hill, NJ, 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, 2016 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/20160922005219/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
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