C. R. Bard, Inc. (NYSE: BCR) today announced that its Lutonix technology center submitted the final module of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) to support approval for the Lutonix® Drug-Coated PTA Dilatation Catheter (DCB). The Lutonix® DCB is being clinically evaluated in the global, multicenter LEVANT 2 randomized clinical trial ( http://www.levant2.com). The purpose of this pivotal investigational device exemption (IDE) trial is to compare the safety and efficacy of the Lutonix® DCB to standard angioplasty balloons for the treatment of peripheral arterial disease (PAD) in superficial femoral (SFA) and popliteal arteries. Drug-coated balloons have received growing attention in recent years as physicians look for effective ways to treat diseased arteries without having to leave a permanent implant behind. Independent forecasts suggest that the global peripheral vascular market for drug-coated balloons could exceed $1 billion annually over the next decade. To date, no such device is approved for use in the United States. While the Lutonix DCB is currently available in Europe and several other countries worldwide, it is limited to investigational use in the United States under an IDE from the FDA. LEVANT 2 raises the bar for scientific rigor in PAD trials. The study was designed to reduce bias in the results in order to accurately and scientifically assess and compare the long-term performance of the treatment modalities alone. Two key aspects of the study design differentiate this trial from recent studies in PAD. First, the LEVANT 2 clinical trial excluded patients who received a stent after initial pre-dilatation of the vessel from the study population. Second, to reduce the potential introduction of bias into the subjective clinical decision for revascularization, the protocol required the clinical assessment to be performed by a physician blinded to the treatment group and the doppler patency measure.
The Lutonix® DCB is part of a global clinical evaluation program. Researchers around the world continue to collect clinical evidence regarding this innovative technology for use in the treatment of PAD. LEVANT 2 was the first drug-coated balloon IDE trial approved by the FDA. The trial randomized 476 patients with diseased femoropopliteal leg arteries at 55 centers worldwide. Data from LEVANT 2, combined with LEVANT I and the LEVANT Continued Access Safety Registry, culminated in over 1000 patients and are the foundation of the submission to the FDA.Designed to treat atherosclerotic lesions in the SFA and popliteal arteries, the Lutonix® DCB is similar to a standard angioplasty balloon but features a proprietary coating containing a low dose of the anti-restenotic drug agent paclitaxal together with excipients sorbital and polysorbate. The combination is intended to form a highly durable coating that allows delivery and subsequent absorption of the drug to the walls of the target vessel. During the procedure, the Lutonix DCB is briefly inflated and is designed to open up the artery to restore blood flow and deliver the drug to the artery wall to prevent restenosis. Timothy M. Ring, chairman and chief executive officer, commented, “This submission marks a key milestone in our drug-coated balloon program, which continues to progress as expected. We look forward to interfacing with the FDA for the purpose of making this important technology available to U.S. patients.” 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. The filing of the pre-market approval application with the FDA should not be construed as an indication of the ultimate outcome of the LEVANT 2 trial or as an indication of the likelihood of the product gaining regulatory approval or being successful commercially. This press release contains some 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 these statements 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. Many factors may cause actual results to differ materially from anticipated results, including product development, sales efforts, the outcome of contingencies such as legal proceedings, and other economic, business competitive and regulatory factors. Please refer to the Cautionary Statement regarding forward-looking information in Bard’s September 30, 2013 10-Q and the information under the caption “risk factors” in the company’s 2012 10-K, including disclosure of the factors that could cause actual results to differ materially from those expressed or implied.