Claret Medical Announces IDE Approval for US Pivotal Trial of Sentinel Cerebral Protection System

February 18, 2014—Claret Medical, Inc. (Santa Rosa, CA) announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration for a multicenter study of its Sentinel cerebral protection system for embolic protection during transcatheter aortic valve replacement (TAVR).

The SENTINEL study will evaluate the Sentinel system during TAVR as compared to the standard of care. Primary endpoints include the reduction in total new lesion volume, as evaluated by diffusion-weighted magnetic resonance imaging, and the rate of major adverse cardiac and cerebrovascular events. The study will be conducted at up to 15 centers and will begin in the first quarter of 2014.

“Protecting cerebral vasculature from embolic debris liberated from multiple sources during TAVR procedures continues to be a critical safety challenge. Recent studies have validated that macroscopic material liberated during these procedures can be effectively captured and safely removed using Claret Medical’s dual-filter embolic protection system,” commented Martin Leon, MD, Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York and Chair of the trial’s Clinical Steering Committee. “We expect the results of the SENTINEL trial to confirm the importance of embolic debris capture and removal during TAVR and to further elucidate the neurocognitive implications of such embolic protection.”