BD Announces Publication of an Independent Analysis of Drug-Coated Balloon Safety Data for Femoropopliteal Peripheral Arterial Disease
This independent analysis evaluated LUTONIX® 035 DCB (N=1093) and standard percutaneous transluminal angioplasty (PTA) (N=250) 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.
"The published patient-level analysis from Syntactx provides important information that health care providers can use to make an informed decision on the use of paclitaxel devices until additional long-term data are available," said
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Monique N. Dolecki
BD Public Relations
BD Investor Relations
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