Overview of FDA Circulatory System Devices Panel virtual meeting on TriGUARD 3 cerebral embolic protection.
Citation: Catheterization & Cardiovascular Interventions. 2022 Jan 27PMID: 35084082Institution: MedStar Heart & Vascular Institute | MedStar Heart & Vascular Institute | MedStar Washington Hospital CenterDepartment: Advanced Cardiac Catheterization Research FellowshipForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2022Local holdings: Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006Abstract: 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. Copyright (c) 2022 Wiley Periodicals LLC.Fiscal year: FY2022Digital Object Identifier: ORCID:- Waksman, Ron:
- http://orcid.org/0000-0002-4063-9226
| Item type | Current library | Collection | Call number | Status | Date due | Barcode |
|---|---|---|---|---|---|---|
| Journal Article | MedStar Authors Catalog | Article | 35084082 | Available | 35084082 |
Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006
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. Copyright (c) 2022 Wiley Periodicals LLC.
English