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FDA Approves Lutonix 035: First Drug-Coated Balloon for Blockages in Leg Arteries
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C.R. Bard, Inc.

Before and After the Lutonix Drug-Coated Balloon
Before and After the Lutonix Drug-Coated Balloon
October 12, 2014 -- The U.S. FDA has approved the first drug-coated balloon for use in opening up blockages in the peripheral arteries, specifically the superficial femoral or popliteal arteries in the leg.

The Lutonix 035 was approved in Europe in 2012 but has taken an additional two years for the FDA to give it the go-ahead. An FDA panel unanimously recommended approval back in June, although there were questions regarding the results that showed no additional benefit in women above the therapy of a standard non-coated balloon.

However, based on the results from the LEVANT 2 clinical trial, the FDA has now given C.R. Bard the go-ahead to market this latest addition to the treatment of peripheral artery disease (PAD).

To help answer the questions raised in the initial review, C.R. Bard will need to initiate two post-approval studies: one, to monitor safety and effectiveness in 657 patients and two, to further assess the results specifically in women.

Angioplasty was first described not in the heart, but in the peripheral leg vessels, by Dr. Charles Dotter in 1964. Oddly, the technique has proven to be more effective in the anatomically complex coronary system than in the leg. Current treatments for PAD include uncoated balloons (PTA), atherectomy devices that "shave" plaque, and both plain and drug-eluting stents. But one of the problems with stents is that they tend to have a higher rate of fracture, due to the mobility of the leg.

So a drug-coated balloon has been thought to be an improvement over the plain PTA balloon. On Friday, the FDA agreed. Although the Lutonix DCB is the first, there are several other DCBs in the FDA pipeline: the most advanced being Medtronic's IN.PACT, which may be approved in short order.

A historical fact: C.R. Bard, the company that acquired Lutonix and is now the manufacturer of the PTA balloon, was the first company to offer a coronary angioplasty balloon, back in the 1980s, the Gruentzig balloon catheter, which was a product of USCI, a division of Bard.

Friday's press release from C.R. Bard, Inc. follows:

The Lutonix® 035 Drug Coated Balloon is the First and Only FDA-Approved DCB Available in the U.S. for the Treatment of Femoropopliteal Occlusive Disease

October 10, 2014 -- Murray Hill, New Jersey -- 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:

[2] Peripheral Arterial Disease – NIH National Heart, Lung, and Blood Institute. Available at:

C. R. Bard, Inc. (, 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 or implied.

Reported by Burt Cohen, October 12, 2014