Claret Medical, Inc., has received Investigational Device Exemption (IDE) approval from the U.S. FDA for a multicenter study of the Company’s Sentinel Cerebral Protection System (CPS) for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
Claret Medical is a developer of innovative solutions for cerebral protection during structural heart interventions, vascular interventions, and cardiac surgery procedures. The SENTINEL study is a key component of Claret’s focus on addressing the problem of stroke during TAVR, a significant unmet clinical need.
The SENTINEL study will evaluate the Sentinel CPS during TAVR as compared to the standard of care. Primary endpoints include reduction in total new lesion volume by diffusion-weighted magnetic resonance imaging (DW-MRI) and rate of major adverse cardiac and cerebrovascular events (MACCE). 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, M.D., 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.”
“This is another step forward in advancing our unique filter-based technology for cerebral protection during TAVR,” said Azin Parhizgar, Ph.D., President and CEO of Claret Medical.
“We look forward to initiating the study and providing physicians the confidence and control needed to capture and remove embolic debris liberated during TAVR procedures – debris that could otherwise be a source of peri-procedural stroke in this patient population.”
Dr. Parhizgar continues, “I am especially pleased that our comprehensive and collaborative pre-IDE discussions allowed us to receive timely approval to conduct the first randomized clinical study in the US for evaluating the role of cerebral protection during TAVR.”
Source: Claret Medical, Inc., PR Newswire