Overview of FDA Circulatory System Devices Panel virtual meeting on TriGUARD 3 cerebral embolic protection. Issue 6 (27th January 2022)

• Record Type: Journal Article
• Authors: Aladin, Amer I.; Case, Brian C.; Wermers, Jason P.; Rogers, Toby; Waksman, Ron
• Is Part Of: Catheterization and cardiovascular interventions. Volume 99:Issue 6(2022)
• Page Start: 1789
• Page End: 1795
• Publication Date: 2022-01-27
• Subjects: aortic valve disease (AVDP) -- percutaneous intervention -- embolic protection devices (EMBP) -- new devices (in general) (NEWD) -- Transcatheter Valve Implantation (TVI); Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.30098
• Languages: English
• ISSNs: 1522-1946

Abstract

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.