Overview of FDA Circulatory System Devices Panel virtual meeting on TriGUARD 3 cerebral embolic protection.
Catheter Cardiovasc Interv
; 99(6): 1789-1795, 2022 05.
Article
in English
| MEDLINE | ID: covidwho-1653183
ABSTRACT
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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Aortic Valve Stenosis
/
Intracranial Embolism
/
Embolic Protection Devices
/
Transcatheter Aortic Valve Replacement
/
COVID-19
Type of study:
Prognostic study
Limits:
Humans
Country/Region as subject:
North America
Language:
English
Journal:
Catheter Cardiovasc Interv
Journal subject:
Cardiology
Year:
2022
Document Type:
Article
Affiliation country:
Ccd.30098
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