TY  - BOOK
AU  - Case, Brian
AU  - Waksman, Ron
AU  - Zhang, Cheng
TI  - 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
PY  - 2021///
KW  - *Angioplasty, Balloon
KW  - *Cardiovascular System
KW  - *Peripheral Arterial Disease
KW  - *Pharmaceutical Preparations
KW  - *Vascular Access Devices
KW  - Angioplasty
KW  - Angioplasty, Balloon/ae [Adverse Effects]
KW  - Coated Materials, Biocompatible
KW  - Humans
KW  - Ischemia/su [Surgery]
KW  - Limb Salvage
KW  - Paclitaxel
KW  - Peripheral Arterial Disease/su [Surgery]
KW  - Peripheral Arterial Disease/th [Therapy]
KW  - Popliteal Artery
KW  - Prospective Studies
KW  - Treatment Outcome
KW  - United States
KW  - United States Food and Drug Administration
KW  - Vascular Patency
KW  - MedStar Heart & Vascular Institute
KW  - MedStar Washington Hospital Center
KW  - Interventional Cardiology Fellowship
KW  - Journal Article
N1  - Available in print through MWHC library: 2002 - present
N2  - 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
UR  - https://dx.doi.org/10.1016/j.carrev.2021.06.016
ER  -