US-based Claret Medical has submitted an investigational device exemption (IDE) application to the US Food and Drug Administration (FDA) 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.
Claret Medical president and CEO Dr Azin Parhizgar noted this application marks a significant step forward in advancing the company’s filter-based embolic protection technology for cerebral protection during TAVR and beyond.
"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," Dr Parhizgar added.
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.