TY  - BOOK
AU  - Medranda, Giorgio
AU  - Waksman, Ron
TI  - Overview of the virtual 2020 FDA's circulatory system devices advisory panel on Neovasc reducer system
SN  - 1522-1946
PY  - 2021///
KW  - *Coronary Sinus
KW  - *COVID-19
KW  - Humans
KW  - SARS-CoV-2
KW  - Treatment Outcome
KW  - United States
KW  - United States Food and Drug Administration
KW  - MedStar Heart & Vascular Institute
KW  - MedStar Washington Hospital Center
KW  - Advanced Cardiac Catheterization Research Fellowship
KW  - Journal Article
N2  - 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
UR  - https://dx.doi.org/10.1002/ccd.29730
ER  -