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Noticias
MURRAY HILL, N.J.--(BUSINESS WIRE)--Oct. 10, 2013-- Today at the Vascular Interventional Advances (VIVA) meeting in Las Vegas, Nevada, Professor Dierk Scheinert, M.D., Head of theDepartment of Medicine, Angiology and Cardiology, Park-Krankenhaus Hospital, Leipzig, Germanyand 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.