TY  - BOOK
AU  - Dan, Kazuhiro
AU  - Garcia-Garcia, Hector M
AU  - Hideo-Kajita, Alexandre
AU  - Khalid, Nauman
AU  - Kolm, Paul
AU  - Shlofmitz, Evan
AU  - Torguson, Rebecca
AU  - Waksman, Ron
AU  - Wermers, Jason P
TI  - 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]
SN  - 0002-8703
PY  - 2020///
KW  - *Angioplasty, Balloon/mt [Methods]
KW  - *Coated Materials, Biocompatible
KW  - *Paclitaxel/pd [Pharmacology]
KW  - *Peripheral Arterial Disease/su [Surgery]
KW  - *Stents
KW  - Antineoplastic Agents, Phytogenic/pd [Pharmacology]
KW  - Congresses as Topic
KW  - Humans
KW  - Prosthesis Design
KW  - United States
KW  - United States Food and Drug Administration
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
KW  - Review
N2  - 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
UR  - https://dx.doi.org/10.1016/j.ahj.2019.12.012
ER  -