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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Bibliographic Details
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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Summary: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.
ISSN:1522-1946
1522-726X
DOI:10.1002/ccd.30098