Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality. [Review] (Record no. 4971)

MARC details
000 -LEADER
fixed length control field 02967nam a22005777a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 200226s20202020 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 0002-8703
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1016/j.ahj.2019.12.012 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code S0002-8703(19)30355-2 [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 32028137
245 ## - TITLE STATEMENT
Title Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality. [Review]
251 ## - Source
Source American Heart Journal. 222:112-120, 2020 04.
252 ## - Abbreviated Source
Abbreviated source Am Heart J. 222:112-120, 2020 04.
252 ## - Abbreviated Source
Former abbreviated source Am Heart J. 222:112-120, 2019 Dec 28.
253 ## - Journal Name
Journal name American heart journal
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2020
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2020
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 2020-02-26
268 ## - Previous citation
-- American Heart Journal. 222:112-120, 2019 Dec 28.
520 ## - SUMMARY, ETC.
Abstract Following the December 2018 publication of a meta-analysis by Katsanos et al reporting higher rates of long-term mortality with the utilization of paclitaxel-related devices (balloons and stents) when compared to control in femoropopliteal arteries, the US Food and Drug Administration (FDA) issued a safety alert in January 2019 and further detailed the implications for future clinical use of these devices in March 2019. The FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee in June 2019. This report summarizes the proceedings of this meeting and the panel's response to the 12 questions posed by the FDA related to the potentially increased late mortality of drug-coated balloons and drug-eluting stents with paclitaxel in patients with peripheral arterial disease. Copyright (c) 2019 Elsevier Inc. All rights reserved.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Angioplasty, Balloon/mt [Methods]
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 *Paclitaxel/pd [Pharmacology]
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 *Stents
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Antineoplastic Agents, Phytogenic/pd [Pharmacology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Congresses as Topic
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 Prosthesis Design
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
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Heart & Vascular Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
657 ## - INDEX TERM--FUNCTION
Medline publication type Review
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Dan, Kazuhiro
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Garcia-Garcia, Hector M
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Hideo-Kajita, Alexandre
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Khalid, Nauman
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Kolm, Paul
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Shlofmitz, Evan
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Torguson, Rebecca
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Waksman, Ron
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Wermers, Jason P
790 ## - Authors
All authors Dan K, Garcia-Garcia HM, Hideo-Kajita A, Khalid N, Kolm P, Shlofmitz E, Torguson R, Waksman R, Wermers JP
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1016/j.ahj.2019.12.012">https://dx.doi.org/10.1016/j.ahj.2019.12.012</a>
Public note https://dx.doi.org/10.1016/j.ahj.2019.12.012
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 02/26/2020   32028137 32028137 02/26/2020 02/26/2020 Journal Article

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