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.
Angioplasty
Angioplasty, Balloon
/ adverse effects
Cardiovascular System
Chronic Limb-Threatening Ischemia
Coated Materials, Biocompatible
Humans
Ischemia
/ surgery
Limb Salvage
Paclitaxel
Peripheral Arterial Disease
/ surgery
Pharmaceutical Preparations
Popliteal Artery
Prospective Studies
Treatment Outcome
United States
United States Food and Drug Administration
Vascular Access Devices
Vascular Patency
Below the knee
Critical limb ischemia
Drug-coated balloon
FDA
Lutonix 014 Drug-Coated Percutaneous Transluminal Angioplasty Catheter
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
12 2021
12 2021
Historique:
received:
15
06
2021
accepted:
16
06
2021
pubmed:
12
7
2021
medline:
1
1
2022
entrez:
11
7
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 34246613
pii: S1553-8389(21)00316-X
doi: 10.1016/j.carrev.2021.06.016
pii:
doi:
Substances chimiques
Coated Materials, Biocompatible
0
Pharmaceutical Preparations
0
Paclitaxel
P88XT4IS4D
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
55-61Informations de copyright
Copyright © 2021. Published by Elsevier Inc.
Déclaration de conflit d'intérêts
Declaration of competing interest Ron Waksman– Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.