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Overview of FDA Circulatory System Devices Panel virtual meeting on TriGUARD 3 cerebral embolic protection

Despite advances in transcatheter aortic valve replacement (TAVR) technology, periprocedural stroke remains a complication of TAVR procedures. The TriGUARD 3 device is designed to be positioned in the aortic arch to deflect debris away from the brachiocephalic, left common carotid, and left subclavi...

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Published in:	Catheterization and cardiovascular interventions 2022-05, Vol.99 (6), p.1789-1795
Main Authors:	Aladin, Amer I., Case, Brian C., Wermers, Jason P., Rogers, Toby, Waksman, Ron
Format:	Article
Language:	English
Subjects:	Aortic arch Aortic valve Aortic Valve - surgery aortic valve disease (AVDP) Aortic Valve Stenosis - surgery Arteries Circulatory system Coronaviruses COVID-19 Embolic Protection Devices embolic protection devices (EMBP) Humans Intracranial Embolism - etiology new devices (in general) (NEWD) percutaneous intervention Reviews Risk Factors Transcatheter Aortic Valve Replacement - adverse effects Transcatheter Valve Implantation (TVI) Treatment Outcome United States United States Food and Drug Administration
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creator	Aladin, Amer I. Case, Brian C. Wermers, Jason P. Rogers, Toby Waksman, Ron
description	Despite advances in transcatheter aortic valve replacement (TAVR) technology, periprocedural stroke remains a complication of TAVR procedures. The TriGUARD 3 device is designed to be positioned in the aortic arch to deflect debris away from the brachiocephalic, left common carotid, and left subclavian arteries during TAVR. The United States Food and Drug Administration (FDA) assembled the Circulatory System Devices Panel to review safety and effectiveness data for the TriGUARD 3 device. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we summarize the data presented by both the sponsor and FDA, as well as the panel discussion.
doi_str_mv	10.1002/ccd.30098
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subjects	Aortic arch Aortic valve Aortic Valve - surgery aortic valve disease (AVDP) Aortic Valve Stenosis - surgery Arteries Circulatory system Coronaviruses COVID-19 Embolic Protection Devices embolic protection devices (EMBP) Humans Intracranial Embolism - etiology new devices (in general) (NEWD) percutaneous intervention Reviews Risk Factors Transcatheter Aortic Valve Replacement - adverse effects Transcatheter Valve Implantation (TVI) Treatment Outcome United States United States Food and Drug Administration
title	Overview of FDA Circulatory System Devices Panel virtual meeting on TriGUARD 3 cerebral embolic protection
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