A U.S. Food and Drug Administration (FDA) panel recently recommended market clearance for the Claret Medical Sentinel Cerebral Protection System (CPS). The recommendation was issued after the Circulatory System Devices Panel reviewed the device last week. If the device gains approval, it will be the first embolic protection system for use during transcatheter aortic valve replacement (TAVR). Used to remove debris from the brain during TAVR, it has been used in over 3,250 patients worldwide and has been studied in three randomized controlled trials. Read more on the issue here. Don’t miss the presentation of Cerebral Embolic Protection Devices During Surgical Aortic Valve Replacement: A Randomized Trial From the Cardiothoracic Surgical Trials Network at ACC.17.

Keywords: Randomized Controlled Trials as Topic, Transcatheter Aortic Valve Replacement, United States Food and Drug Administration

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