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. (Record no. 6672)

MARC details
000 -LEADER
fixed length control field 03331nam a22006497a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 210726s20212021 xxu||||| |||| 00| 0 eng d
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1016/j.carrev.2021.06.016 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code S1553-8389(21)00316-X [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 34246613
245 ## - TITLE STATEMENT
Title 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.
251 ## - Source
Source Cardiovascular Revascularization Medicine. 33:55-61, 2021 12.
252 ## - Abbreviated Source
Abbreviated source Cardiovasc Revasc Med. 33:55-61, 2021 12.
252 ## - Abbreviated Source
Former abbreviated source Cardiovasc Revasc Med. 2021 Jun 19
253 ## - Journal Name
Journal name Cardiovascular revascularization medicine : including molecular interventions
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2021
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2022
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Publication date 2021 Jun 19
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
266 ## - Date added to catalog
Date added to catalog 2021-07-26
268 ## - Previous citation
-- Cardiovascular Revascularization Medicine. 2021 Jun 19
269 ## - Original dates
Original fiscal year FY2021
501 ## - WITH NOTE
Local holdings Available in print through MWHC library: 2002 - present
520 ## - SUMMARY, ETC.
Abstract 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.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Angioplasty, Balloon
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Cardiovascular System
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Peripheral Arterial Disease
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Pharmaceutical Preparations
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Vascular Access Devices
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Angioplasty
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Angioplasty, Balloon/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Coated Materials, Biocompatible
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Ischemia/su [Surgery]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Limb Salvage
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Paclitaxel
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Peripheral Arterial Disease/su [Surgery]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Peripheral Arterial Disease/th [Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Popliteal Artery
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Prospective Studies
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element United States
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element United States Food and Drug Administration
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Vascular Patency
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Heart & Vascular Institute
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Washington Hospital Center
656 ## - INDEX TERM--OCCUPATION
Department Interventional Cardiology Fellowship
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Case, Brian
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Waksman, Ron
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Zhang, Cheng
790 ## - Authors
All authors Case BC, Torguson R, Waksman R, Zhang C
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1016/j.carrev.2021.06.016">https://dx.doi.org/10.1016/j.carrev.2021.06.016</a>
Public note https://dx.doi.org/10.1016/j.carrev.2021.06.016
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 07/26/2021   34246613 34246613 07/26/2021 07/26/2021 Journal Article

Powered by Koha