BD Statement on Meta-Analysis Published Regarding Drug-Coated Balloons for Below-the-Knee Applications

Jan 17, 2020

The meta-analysis published by Dr. Konstantinos Katsanos, et al in the Journal of Vascular and Interventional Radiology on January 14 focused on amputation-free survival (defined as freedom from all-cause mortality and major amputation) and target lesion revascularization of five different paclitaxel-coated devices studied specifically in below-the-knee (BTK) arteries in patients with critical limb ischemia (CLI) up to one year. The findings showed increased all-cause mortality and major amputation rates associated with higher-dose paclitaxel-coated products. However, the authors noted that “the single low-dose 2.0-ug/mm2 trial [LUTONIX? 014 Drug Coated Balloon] was found to be safe . . . and effective.”

The safety findings for the LUTONIX? 014 Drug Coated Balloon (DCB) in this meta-analysis further support the positive safety outcomes reflected in the published 6-month safety data, and the 36-month interim safety data presented at VERVE, from the LUTONIX?  014 DCB IDE, level 1 clinical trial for the BTK indication. BD will be presenting additional LUTONIX? 014 DCB BTK interim three-year safety data at the upcoming Leipzig Interventional Course (LINC) 2020 Annual Conference in Leipzig, Germany later this month. The LUTONIX? 014 DCB has been commercially available in Europe, Canada and Australia for treatment of the BTK arteries associated with CLI since 2013. In the U.S., the LUTONIX? 014 DCB is an investigational device, limited by U.S. law to investigational use.

Sandra Moskowitz

201 847 5976
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