SANTA ROSA, Calif., Dec. 2, 2013 /PRNewswire/ -- Claret Medical, Inc., a developer of innovative solutions for cerebral protection during structural heart interventions, vascular interventions, and cardiac surgery procedures, announced that it has submitted an investigational device exemption (IDE) application to the US Food and Drug Administration for a multicenter study of the Company's Sentinel Cerebral Protection System (CPS) for embolic protection during Transcatheter Aortic Valve Replacement (TAVR). The IDE application is the result of comprehensive and collaborative pre-IDE discussions.
"This application marks a significant step forward in advancing our unique filter-based embolic protection technology for cerebral protection during TAVR and beyond" said Azin Parhizgar, PhD, President and CEO of Claret Medical. "We look forward to starting the study to evaluate the safety and efficacy of the Sentinel CPS in capturing and retrieving embolic debris dislodged during TAVR procedures that could be harmful to patients."
The SENTINEL study will evaluate the Sentinel CPS during TAVR 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 (MACCE). The study will be conducted at up to 15 centers in the US and Europe.
Dr. Martin Leon, Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York and chair of the study's Clinical Steering Committee, noted, "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."
Claret Medical is the leader in cerebral protection during TAVR with more than 600 cases performed in the European Union since 2012.
About Claret Medical
Claret Medical is a privately-held company focused on innovative solutions for cerebral protection during structural heart interventions, vascular interventions, and cardiac surgery procedures. Claret Medical is currently focusing developmental and clinical research resources on addressing the problem of stroke during TAVR, a significant unmet clinical need.
Claret Medical, Inc.
SOURCE Claret Medical, Inc.