MedStar Authors catalog › Details for: 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]
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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]

by Dan, Kazuhiro; Garcia-Garcia, Hector M; Hideo-Kajita, Alexandre; Khalid, Nauman; Kolm, Paul; Shlofmitz, Evan; Torguson, Rebecca; Waksman, Ron; Wermers, Jason P.
Citation: ; American Heart Journal. 222:112-120, 2020 04..Journal: American heart journal.Published: ; 2020; ; ISSN: 0002-8703.Full author list: Dan K; Garcia-Garcia HM; Hideo-Kajita A; Khalid N; Kolm P; Shlofmitz E; Torguson R; Waksman R; Wermers JP.UI/PMID: 32028137.Subject(s): *Angioplasty, Balloon/mt [Methods] | United States Food and Drug Administration | United States | *Stents | Prosthesis Design | *Peripheral Arterial Disease/su [Surgery] | *Paclitaxel/pd [Pharmacology] | Humans | Congresses as Topic | *Coated Materials, Biocompatible | Antineoplastic Agents, Phytogenic/pd [Pharmacology]Institution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal Article | ReviewOnline resources: Click here to access online Digital Object Identifier: https://dx.doi.org/10.1016/j.ahj.2019.12.012 (Click here) Abbreviated citation: ; Am Heart J. 222:112-120, 2020 04.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.

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