Bard’s Drug Coated Balloon, Below the Knee Clinical Trial Discussed at Leipzig Interventional Course


January 28, 2014
Bard Drug Coated Balloon Below the Knee Clinical Trial Peripheral Artery Disease
January 30, 2014 — Experts presented six-month LEVANT 2 trial results for C. R. Bard Inc.’s Lutonix drug coated balloon (DCB) and provided updates on the ongoing Lutonix Below the Knee (BTK) Clinical Trial at the Leipzig Interventional Course (LINC) in Leipzig, Germany.
The symposium took place Jan. 29. 
LEVANT 2 study design — Professor Dierk Scheinert, M.D., head of the Department of Medicine, Angiology and Cardiology, Park-Krankenhaus Hospital, Leipzig, Germany
Single center experience global SFA registry — Michael Lichtenberg, M.D., Klinikum Arnsberg, Arnsberg, Germany
BTK applications and Lutonix BTK Clinical Trial — Professor Marianne Brodmann, M.D., associate professor and assistant medical director, Division of Angiology, Medical University Graz, Austria
Techniques in complex BTK cases — Francesco Liistro, M.D., San Donato Hospital, Arezzo, Italy
Pre-clinical safety data and technology review — Renu Virmani, M.D., CVPath Institute, Gaithersburg, Maryland, United States
A single center experience with Lutonix — Peter Baron von Bilderling, M.D., Gefäßpraxis im Tal, Munich, Germany
Bard announced in June 2013 enrollment of the first patient in the Lutonix BTK Clinical Trial. The global and multi-center, randomized Investigational Device Exemption (IDE) trial is ongoing and is intended to compare the safety and effectiveness of the Lutonix 014 Drug Coated PTA Dilatation Catheter to a standard angioplasty balloon for the treatment of CLI. The trial is expected to enroll several hundred patients at 55 sites worldwide.
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