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. 

 -  2021 
<br/><br/>Available in print through MWHC library: 2002 - present 
<br/><br/> 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. Copyright (c) 2021. Published by Elsevier Inc. 
<br/><br/><br/>English 
<br/><br/><label>Standard No.: </label>10.1016/j.carrev.2021.06.016 [doi] S1553-8389(21)00316-X [pii] 
<br/><br/><label>Subjects--Topical Terms: </label><br/>*Angioplasty, Balloon<br/>*Cardiovascular System<br/>*Peripheral Arterial Disease<br/>*Pharmaceutical Preparations<br/>*Vascular Access Devices<br/>Angioplasty<br/>Angioplasty, Balloon/ae [Adverse Effects]<br/>Coated Materials, Biocompatible<br/>Humans<br/>Ischemia/su [Surgery]<br/>Limb Salvage<br/>Paclitaxel<br/>Peripheral Arterial Disease/su [Surgery]<br/>Peripheral Arterial Disease/th [Therapy]<br/>Popliteal Artery<br/>Prospective Studies<br/>Treatment Outcome<br/>United States<br/>United States Food and Drug Administration<br/>Vascular Patency
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Heart & Vascular Institute<br/>MedStar Washington Hospital Center
<br/><br/><label>Index Terms--Occupation: </label><br/>Interventional Cardiology Fellowship
<br/><br/><label>Index Terms--Function: </label><br/>Journal Article