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Overview of the virtual 2020 FDA's circulatory system devices advisory panel on Neovasc reducer system.

MedStar author(s):

Citation: Catheterization & Cardiovascular Interventions. 98(6):1152-1158, 2021 11 15.PMID: 33893757Institution: MedStar Heart & Vascular Institute | MedStar Washington Hospital CenterDepartment: Advanced Cardiac Catheterization Research FellowshipForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Coronary Sinus | *COVID-19 | Humans | SARS-CoV-2 | Treatment Outcome | United States | United States Food and Drug AdministrationYear: 2021 ISSN:

1522-1946

Name of journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & InterventionsAbstract: Refractory angina is considered a devastating condition with limited medical and therapeutic options. The Neovasc Reducer device, when implanted in the coronary sinus, is designed to alleviate anginal symptoms. However, the available clinical data are sparse. The US Food and Drug Administration (FDA) assembled the Circulatory Systems Devices Panel to discuss the Reducer's safety and effectiveness. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we detail the deliberation and discussion among the circulatory panel members, including their final vote. Copyright (c) 2021 Wiley Periodicals LLC.All authors: Medranda GA, Torguson R, Waksman ROriginally published: Catheterization & Cardiovascular Interventions. 2021 Apr 24Fiscal year: FY2022Fiscal year of original publication: FY2021Digital Object Identifier:

https://dx.doi.org/10.1002/ccd.29730

ORCID:

https://orcid.org/0000-0001-9804-3786 https://orcid.org/0000-0002-4063-9226 https://orcid.org/0000-0001-9804-3786 https://orcid.org/0000-0002-4063-9226
https://orcid.org/0000-0001-9804-3786 https://orcid.org/0000-0002-4063-9226 https://orcid.org/0000-0001-9804-3786 https://orcid.org/0000-0002-4063-9226

Date added to catalog: 2021-06-07

Holdings ( 1 )
Title notes ( 2 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	33893757	Available		33893757

Refractory angina is considered a devastating condition with limited medical and therapeutic options. The Neovasc Reducer device, when implanted in the coronary sinus, is designed to alleviate anginal symptoms. However, the available clinical data are sparse. The US Food and Drug Administration (FDA) assembled the Circulatory Systems Devices Panel to discuss the Reducer's safety and effectiveness. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we detail the deliberation and discussion among the circulatory panel members, including their final vote. Copyright (c) 2021 Wiley Periodicals LLC.

English