Overview of the virtual 2021 FDA's Circulatory System Devices Advisory Panel on Lutonix 014 Drug-Coated Percutaneous Transluminal Angioplasty Catheter for below-the-knee lesions in critical limb ischemia

Peripheral artery disease, along with subsequent critical limb ischemia (CLI), is highly prevalent, increases with age, and carries high morbidity and mortality. Specific devices for treatment of below-the-knee (BTK) lesions are limited. On February 17, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to consider a premarket approval application for the Lutonix 014 Drug-Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Becton, Dickinson and Company, Franklin Lakes, New Jersey) for the treatment of obstructive de novo or non-stented restenotic lesions in BTK vessels (popliteal, tibial, and peroneal arteries) in patients with CLI. We summarize the presentations and the panel deliberations, including voting outcome and recommendations for risk versus benefit.