Claret Medical is seeking approval from the US Food and Drug Administration (FDA) for its Sentinel cerebral protection system (CPS).
The company has submitted a marketing application to the FDA for clearance of the system to protect transcatheter aortic valve replacement (TAVR) patients from cerebral embolic events.
The system is claimed to be the only device designed to protect the brain by capturing and removing debris dislodged during TAVR that that enters cerebral circulation and carries the potential for stroke.
The filing was based on data from the recently completed Sentinel pivotal IDE prospective, randomized, controlled and blinded study of 363 TAVR patients at 19 centers in the US and Germany.
According to the company, the study trial endpoints included reduction in new ischemic cerebral infarcts, major adverse cardiac or cerebrovascular events, neurocognitive outcomes, and qualitative and quantitative histopathological findings.
In 2013, the company received CE mark approval for the Sentinel system.
Claret Medical president and CEO Azin Parhizgar said: “Our contribution in building significant new science will help the rapidly growing TAVR field embrace the critical role of cerebral protection in all left heart and endovascular procedures.
“These studies incorporate a level of rigorous brain evaluation never before undertaken, including systematic and serial state-of-the-art 3-Tesla MRI neuroimaging of patients’ pre-existing cerebrovascular disease, as determined by a baseline MRI, as well as neurological, histopathological and neurocognitive evaluations.”
Claret Medical is engaged in the development of novel solutions for cerebral protection during structural heart interventions, vascular interventions, and cardiac surgery procedures.