Overview of the virtual 2020 FDA's circulatory system devices advisory panel on Neovasc reducer system.
Overview of the virtual 2020 FDA's circulatory system devices advisory panel on Neovasc reducer system.
- 2021
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
1522-1946
10.1002/ccd.29730 [doi]
*Coronary Sinus
*COVID-19
Humans
SARS-CoV-2
Treatment Outcome
United States
United States Food and Drug Administration
MedStar Heart & Vascular Institute
MedStar Washington Hospital Center
Advanced Cardiac Catheterization Research Fellowship
Journal Article
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
1522-1946
10.1002/ccd.29730 [doi]
*Coronary Sinus
*COVID-19
Humans
SARS-CoV-2
Treatment Outcome
United States
United States Food and Drug Administration
MedStar Heart & Vascular Institute
MedStar Washington Hospital Center
Advanced Cardiac Catheterization Research Fellowship
Journal Article