Updated Sept. 5, 2014, at 11:00 a.m. EST.
Claret Medical announced this week that it enrolled the final patient in a European clinical trial as it chases FDA approval for its Sentinel cerebral protection device.*
Claret’s CLEAN-TAVI trial just enrolled the last of 100 patients who underwent transcatheter aortic valve implantation procedures with Medtronic’s (NYSE:MDT) CoreValve system. The Sentinel device complements the procedure by providing a filter to capture and remove any dislodged debris before it can make its way to the brain.
The study was the 1st of its kind examining the role of a cerebral filter in preventing lesions during TAVI operations. The results have important implications for Claret as it pursues regulatory approval in the U.S. as the 1st device to both capture and remove blood clots and other tissue.
Sentinel has had FDA investigational device exemption since February this year after winning European CE Mark approval a month earlier.
Since closing the CLEAN-TAVI trial, Claret has already launched another study, the European SENTINEL-H post-market observational trial. The SENTINEL-H trial will enroll up to 250 patients at 10-15 centers who will undergo TAVI with new newest model of the Sentinel system.
The California-based company is on a roll, having just closed an $18 million series B funding round.
*Corrected: This article mistakenly stated that CLEAN-TAVI is a U.S. study. It is a European study.
