SANTA ROSA -- Startup therapeutic device maker Claret Medical, Inc. on Tuesday said it received a U.S. Food and Drug Administration go-ahead to study a system designed to protect against stroke and brain blood clots during heart-valve surgery.
The FDA granted an investigational device exemption for the Santa Rosa-based company's Sentinel Cerebral Protection System, intended to protect the brain during surgery via catheters, such as structural heart and vascular interventions.
The startup was formed four years ago. The study is set to be conducted at up to 15 centers starting in the first quarter.
"Protecting cerebral vasculature from embolic debris liberated from multiple sources during (transcatheter aortic valve replacement) procedures continues to be a critical safety challenge," said 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. "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. 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."
The study will evaluate the Sentinel protection system during transcathther aortic valve replacement, compared with the current standard of care. Outcomes the study will watch for primarily include a reduction in total new lesion volume by diffusion-weighted magnetic resonance imaging and the rate of major adverse cardiac and cerebrovascular events.
"This is another step forward in advancing our unique filter-based technology for cerebral protection during (transcatheter aortic valve replacement)," said Azin Parhizgar, PhD, 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 (transcatheter aortic valve replacement) procedures - debris that could otherwise be a source of peri-procedural stroke in this patient population."