MURRAY HILL, N.J.--(BUSINESS WIRE)--Oct. 10, 2014--
C. R. Bard, Inc. (NYSE: BCR) today announced the U.S. Food and Drug
Administration (FDA) approval of the Lutonix® 035 Drug Coated
Balloon (DCB) Catheter for percutaneous transluminal angioplasty (PTA),
after pre-dilatation, for the treatment of de novo or restenotic lesions
up to 150mm in length in native vascular disease of the superficial
femoral or popliteal arteries with reference vessel diameters of 4-6mm.
This approval follows a unanimous favorable recommendation from the
FDA’s Circulatory Systems Devices Advisory Panel in June 2014. The
Lutonix® 035 DCB—the first and only FDA-approved DCB in the
U.S.— is an angioplasty balloon coated with a therapeutic dose of the
drug paclitaxel, and also utilizes standard mechanical dilatation of the
vessel to restore blood flow for patients with peripheral arterial
disease (PAD) in the femoropopliteal arteries.
FDA approval of the Lutonix® 035 DCB was supported by results
of the LEVANT 2 pivotal study, a global, prospective, single-blind,
randomized, 54-site study (42 sites in the U.S. and 12 in Europe) that
enrolled all patients under one protocol. At one year, the LEVANT 2
study demonstrated improved patency of the Lutonix® 035 DCB
compared to standard PTA: 73.5 percent vs. 56.8 percent, p<0.001 by
Kaplan-Meier time-to-event analysis. It also demonstrated clinical
benefits of sustained improvement in Rutherford Class and improved
walking distance scores. The LEVANT 2 study followed a rigorous blinding
protocol designed to reduce bias in the results to accurately and
scientifically assess and compare the long-term performance of key
clinical measures. The LEVANT clinical program, which includes registry
data, enrolled more than 1,000 patients and demonstrated robust safety
of the device comparable to PTA, including the same low rate of distal
embolic events and rate of reintervention for thrombotic events.
“The Lutonix® 035 DCB provides physicians with an opportunity
to enhance the treatment protocol for patients with occlusive disease of
the femoropopliteal artery with a safe, effective method of delivering
paclitaxel directly to stenosed vessels,” said Kenneth Rosenfield, M.D.,
Section Head, Vascular Medicine and Intervention Chairman, Massachusetts
General Hospital, Professor of Medicine, Harvard University School of
Medicine and LEVANT 2 Principal Investigator. “This DCB is a new
first-line therapy for treating blockages, without closing the door to
other treatment options down the road. I envision also using the Lutonix®
035 DCB to complement existing therapy options.”
The American Heart Association (AHA) estimates that PAD, a
life-threatening condition, affects at least 8 million Americans by
narrowing arteries and reducing blood flow to the limbs.1
Patients with PAD in the femoropopliteal arteries are at risk for
lower-extremity amputation, particularly in people over the age of 50.2
Successful treatment of PAD in the femoropopliteal arteries requires
improved blood flow (patency) for longer periods of time. While there
are both non-invasive and invasive treatment options for these arteries
available, each has associated limitations. PTA is currently the
first-line, standard-of-care treatment for PAD, according to the
American College of Cardiology and AHA 2011 guidelines; however, it is
limited by its relative lack of long-term patency.
“In line with Bard’s commitment to delivering products that improve
patient care, we are proud to offer another Bard first-of-its-kind
innovation that expands therapy options for this painful, progressive
and debilitating disease,” said Timothy M. Ring, chairman and chief
executive officer of C. R. Bard. “The Lutonix® 035 DCB gives
clinicians another option as they seek to provide prolonged patency to
patients confronted with femoropopliteal occlusive disease.”
The Lutonix® 035 DCB has been available commercially in
Europe since 2012.
1 Why PAD Matters – American Heart Association Web site.
Available at: http://www.heart.org/HEARTORG/Conditions/More/PeripheralArteryDisease/Why-PAD-Matters_UCM_301303_Article.jsp.
2 Peripheral Arterial Disease – NIH National Heart, Lung, and
Blood Institute. Available at: https://www.nhlbi.nih.gov/health/health-topics/topics/pad.
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, 2014
Form 10-Q for more detailed information about these and other factors
that may cause actual results to differ materially from those expressed
Source: C. R. Bard, Inc.
C. R. Bard, Inc.
Vice President, Investor Relations
Vice President and Treasurer