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
em En
| MEDLINE
| ID: mdl-35084082
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Estenose da Valva Aórtica
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Embolia Intracraniana
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Dispositivos de Proteção Embólica
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Substituição da Valva Aórtica Transcateter
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COVID-19
Tipo de estudo:
Etiology_studies
/
Risk_factors_studies
Limite:
Humans
País como assunto:
America do norte
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article