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An FDA advisory committee turned thumbs down on Becton Dickinson s Lutonix 014 drug-coated balloon (DCB) for peripheral artery disease (PAD) during a virtual meeting on Wednesday.
Circulatory System Devices Panel members voted 14-3 (with one abstention) that the benefits of the investigational angioplasty catheter do not outweigh its risks as a treatment for patients with critical limb ischemia (CLI) who have obstructive de novo or non-stented restenotic lesions in below-the-knee (BTK) arteries.
Committee members were largely unconvinced that the Lutonix DCB was supported by adequate efficacy data.
In the pivotal Lutonix BTK IDE trial, the device showed a 10.5% absolute advantage in the primary efficacy endpoint (combined primary patency and limb salvage) at 6 months that was not significant under Bayesian analysis. Such improvement, if any, vanished by 12 months, and the endpoint started to favor the regular percutaneous transluminal angioplast ....

United States , Nicole Lou , Robert Yeh , Bernard Gersh , Bram Zuckerman , Becton Dickinson Lutonix , Joaquin Cigarroa , Oregon Health Science University In Portland , Mayo Clinic College Of Medicine , Harvard Medical School , Circulatory System Devices Panel , Becton Dickinson , System Devices Panel , Oregon Health , Science University , Mayo Clinic College , Medpage Today , Ischemic Colitis , Disorder Of Artery , Disorder Of Blood Vessel , Generalized Atherosclerosis , ஒன்றுபட்டது மாநிலங்களில் , நிக்கோல் லூ , ராபர்ட் ஆமாம் , பெர்னார்ட் கெர்ஷ , பிராம் ஸக்மந் ,