Today at the Transcatheter Cardiovascular Therapies (TCT) conference in San Francisco, California, Kenneth Rosenfield, M.D., Section Head for Vascular Medicine and Intervention, Massachusetts General Hospital and LEVANT 2 Co-Primary Investigator, is presenting information related to the study design, demographics, and six-month follow-up results from the patients randomized in the LEVANT 2 Lutonix Drug-Coated Balloon (DCB) trial.
LEVANT 2 raises the bar for scientific rigor in peripheral artery disease (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, protocol required the clinical assessment to be performed by a physician blinded to the treatment group and the Doppler patency measure.
The six-month follow-up results from randomized patients who were treated with the Lutonix DCB demonstrated safety comparable to uncoated balloons (94.0% vs 94.1%) and superior primary patency (92.3% vs 82.7%, p=0.003) by Kaplan-Meier time-to-event analysis.C. R. Bard, Inc. (NYSE:BCR) has posted the presentation slides on its website for a limited time at http://investorrelations.crbard.com. 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 data provided in the above-mentioned presentation should not be construed as representative 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. Six-month results are not necessarily indicative or predictive of longer-term results. 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.