Patient Treated With Experimental Brain Protection System During TAVR
Claret Medical said Monday that the first U.S. patient had been successfully treated in its efficacy study of the Sentinel cerebral protection system, a small catheter designed to protect the brain from stroke during transcatheter aortic valve replacement and other endovascular procedures.
The randomized, controlled and blinded Sentinel trial has enrolled 284 patients in 15 sites nationwide, according to the Santa Rosa, Calif., devicemaker. It is the first clinical study in the U.S. to evaluate the role of cerebral protection during TAVR surgery.
The primary endpoints are reduction in total new lesion volume, depicted with MRI, and major adverse cardiac and cerebrovascular events. Secondary endpoints, such as neurocognitive and histopathological outcomes, will be compared in the trial arms with and without cerebral protection, Claret said.
The Sentinel system includes two small filters to capture and remove embolic debris that might otherwise flow through the bloodstream to the brain. The catheter is inserted through an artery and removed when the procedure is completed, the company said.
Susheel Kodali, co-principal investigator for the Sentinel trial, performed the first procedure at New York and Presbyterian Hospital/Columbia University Medical Center.
Last month, Claret reported 30-day results from the CLEAN-TAVI trial of the Sentinel system, which showed a 53 percent reduction in total volume of new brain lesions and 60 percent reduction in number of new lesions two days after TAVR. — Kellen Owings
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