Panel to Consider Claret Medical Sentinel System

The FDA Circulatory System Devices Panel will consider 2/23 a Claret Medical De Novo 510(k) application for its Sentinel cerebral protection system for use in patients undergoing transcatheter aortic valve replacement (TAVR). The company is asking that the device be indicated for use as a cerebral protection device to capture and remove embolic material while TAVR procedures are performed to reduce ischemic injury to the brain peri-procedurally.

An FDA briefing document, prepared by the CDRH Division of Cardiovascular Devices and released in advance of the meeting, notes that in a clinical study, the device met its safety criterion but did not meet the efficacy criterion of reducing the risk of stroke in TAVR patients.

Panel members will be asked to assess the significance of the clinical study results and comment on the benefit-to-risk ratio of use the device for the requested indication, the document says.