Overview of FDA Circulatory System Devices Panel virtual meeting on TriGUARD 3 cerebral embolic protection. 

 -  2022 
<br/><br/>Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006 
<br/><br/> 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. 
<br/><br/><br/>English 
<br/><br/><label>Standard No.: </label>10.1002/ccd.30098 [doi] 
<br/><br/><label>Subjects--Topical Terms: </label><br/>IN PROCESS -- NOT YET INDEXED
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Heart & Vascular Institute<br/>MedStar Heart & Vascular Institute<br/>MedStar Washington Hospital Center
<br/><br/><label>Index Terms--Occupation: </label><br/>Advanced Cardiac Catheterization Research Fellowship
<br/><br/><label>Index Terms--Function: </label><br/>Journal Article