Claret Medical said it filed asked for an investigative device exemption from the FDA for a clinical trial of its Sentinel cerebral protection system.
Santa Rosa, Calif.-based Claret wants to conduct a multicenter study using the Sentinel for embolic protection during transcatheter aortic valve implantation, comparing use of the Sentinel device with standard care.
“This application marks a significant step forward in advancing our unique filter-based embolic protection technology for cerebral protection during [TAVI] 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 [TAVI] procedures that could be harmful to patients,” president & CEO Azin Parhizgar said in prepared remarks.
Claret, which raised $3.6 million in July in a convertible promissory notes offering, already has an embolic debris filter on the market in Europe. Its Montage dual-filter system won CE Mark approval in the European Union back in November 2011, when Claret drummed up a $3.4 million Series A round.
Study results released earlier this year showed that the Montage device captured embolic debris traveling to the brain in 75% of patients undergoing TAVI.