Claret Medical is clear to launch a pivotal U.S. trial of its Sentinel cerebral protection system, having won FDA approval to evaluate the device in patients undergoing transcatheter aortic valve implantation.
The study is slated to begin in the 1st quarter of 2014 and will involve up to 15 clinical centers, Claret reported.
The Sentinel filters potentially dangerous blood clots that may dislodge during TAVI procedures, preventing the debris from traveling to the brain where it could result in a stroke or other complications. The device just last month won CE Mark approval for marketing in the European Union.
"This is another step forward in advancing our unique filter-based technology for cerebral protection during TAVR," president & CEO Azin Parhizgar said in prepared remarks. "I am especially pleased that our comprehensive and collaborative pre-IDE discussions allowed us to receive timely approval to conduct the 1st randomized clinical study in the U.S. for evaluating the role of cerebral protection during TAVR."
