BD announces independent analysis publication of LUTONIX 035 DCB femoropopliteal
Becton Dickinson announced the publication of a company-initiated, independent analysis of the LUTONIX 035 Drug Coated Balloon femoropopliteal clinical program in the Journal of the American College of Cardiology: Cardiovascular Interventions. These data were simultaneously presented in a late-breaking session at Transcatheter Cardiovascular Therapeutics, the annual scientific symposium of the Cardiovascular Research Foundation. This independent analysis evaluated LUTONIX 035 DCB and standard percutaneous transluminal angioplasty safety outcomes using patient-level data and propensity-matching from three LUTONIX DCB randomized, controlled trials: LEVANT 1, LEVANT 2 and LEVANT Japan, as well as the Continued Access cohort of the LEVANT 2 trial, and confirmed that there was no statistically significant increase in mortality with the use of LUTONIX 035 DCB. Further, a medical advisory committee comprised of an interventionalist and oncologist re-evaluated the cause of death in the LEVANT 1 and LEVANT 2 trials, including the LEVANT 2 Continued Access cohort. This independent review confirmed through adjudication that zero deaths were determined to be related to paclitaxel. Moreover, no clustering or pattern of death in any cardiovascular or non-cardiovascular categories was observed, which would have indicated a causal relationship between paclitaxel and death.