First of Its Kind Study Design Raises the Bar for Scientific Rigor in Drug-Coated Balloons
Today at the Vascular Interventional Advances (VIVA) meeting in Las Vegas, Nevada, Professor Dierk Scheinert, M.D., Head of the Department of Medicine, Angiology and Cardiology, Park-Krankenhaus Hospital, Leipzig, Germany and LEVANT 2 Co-Primary Investigator, is presenting information related to the LEVANT 2 Lutonix Drug-Coated Balloon (DCB) study design.
Unlike recent studies in Peripheral Artery Disease (PAD), the LEVANT 2 clinical trial excluded patients who received a stent after initial pre-dilatation of the vessel from the study population. The purpose of this more rigorous approach is to remove bias from the study results to accurately and scientifically assess and compare the long-term performance of the treatment modalities alone. After successful pre-dilatation without stenting, the study randomized 476 patients 2 to 1 to the Lutonix DCB versus an uncoated balloon.
Professor Scheinert is also presenting six-month results from 56 patients who were treated with the Lutonix DCB prior to the beginning of the randomized trial, otherwise known as roll-in patients.
C. R. Bard, Inc. (NYSE:BCR) has posted the presentation slides on its website for a limited time at .
The roll-in data provided in the above-mentioned presentation should not be construed as representative of the ultimate outcome of the LEVANT 2 trial or seen as an indication of the trial meeting its primary endpoints 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 June 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.