Claret Medical said today that the 1st patient has been treated in a U.S. pivotal trial of its Sentinel cerebral protection system, which is designed to guard against stroke during transcatheter aortic valve implantation.
The 1st patient was treated at New York & Presbyterian Hospital/Columbia University Medical Center by Dr. Susheel Kodali. The Sentinel trial will evaluate 284 patients at up to 15 centers nationwide, according to a press release.
The Sentinel device is designed to capture and remove debris dislodged during endovascular procedures, using a proximal embolic filter delivered to the brachiocephalic artery, and a distal embolic filter delivered to the left common carotid artery. After a TAVI procedure, the filters are withdrawn into the catheter along with any captured debris.
"Any occurrence of stroke is o1ne too many, and results from this clinical trial may give us the evidence needed to make cerebral protection a standard of care during TAVI, as it is in carotid artery stenting," co-principal investigator Dr. Samir Kapadia of the Cleveland Clinic said in prepared remarks. "By both capturing and removing embolic debris released during TAVI, the Sentinel CPS may offer a unique neuroprotective benefit. We expect TAVI device to demonstrate a similarly significant reduction in the number and size of lesions in the brains of TAVR patients when cerebral protection is used."
Claret Medical said early results have demonstrated a 53% reduction in the total volume of new brain lesions and a 60% reduction in the number of new brain lesions 2 days after TAVI.
Last January, Claret Medical won CE Mark approval to launch the Sentinel CPS in Europe, and the following month received an Investigational Device Exemption from the FDA for U.S. trials.
In August, Claret Medical raised $18 million from Santé Ventures and other investors.