Claret Medical Seeks Approval of US Pivotal Trial for the Sentinel Cerebral Protection System

December 2, 2013—Claret Medical, Inc. (Santa Rosa, CA) announced that it has submitted an investigational device exemption application to the US Food and Drug Administration for a multicenter study of the company's Sentinel cerebral protection system to provide embolic protection during transcatheter aortic valve replacement (TAVR). 

According to the company, the study will evaluate the safety and efficacy of the Sentinel system in capturing and retrieving embolic debris dislodged during TAVR procedures as compared against the standard of care. Primary endpoints include reduction in total new lesion volume by diffusion-weighted magnetic resonance imaging (DW-MRI) and occurrence of major adverse cardiac and cerebrovascular events.

The study will be conducted at up to 15 centers in the United States and Europe. Martin Leon, MD, is Chair of the study's clinical steering committee. Dr. Leon is Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York City.

In Claret Medical's announcement, Dr. Leon commented, “This study is designed to include patients with severe, symptomatic, calcified native aortic valve stenosis, who are candidates for undergoing TAVR. In this patient population, we expect not only to confirm the importance of cerebral protection in reducing embolic burden traveling to the brain, but also to elucidate the potential role of DW-MRI positive embolic lesions and their effect on the patient's neurocognitive capacity.”