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Claret Medical receives FDA clearance to market Sentinel Cerebral Protection System in the U.S.

Press releases may be edited for formatting or style | June 05, 2017 Cardiology

In clinical studies, the Sentinel removed visible debris headed towards the brain in 99 percent of TAVR cases, regardless of the type of replacement valve used, and with no added risk. The Sentinel is simple to use, with 99 percent deployment success in a median deployment time of four minutes. It is securely positioned away from the aortic arch, avoiding damage to that anatomy, minimizing interference with TAVR catheters, and enabling physicians to focus solely on the TAVR procedure.

“The advent of ‘protected TAVR’ is here, and we believe that Sentinel will create a paradigm shift in how TAVR patients are treated in the U.S.,” said Claret Medical President and Chief Executive Officer Azin Parhizgar, PhD. “The science behind the device has set a high bar for other embolic protection devices to meet and its safety record is indisputable. By helping to reduce the occurrence of peri-procedural strokes, we intend to provide patients and physicians with greater peace of mind as they approach a TAVR procedure.”

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The Sentinel is the most-studied device in the field of TAVR cerebral protection, having been systematically evaluated in more than 1,000 patients in multiple studies, including three randomized controlled trials. More than 3,500 patients worldwide have been protected with the device to-date, and it is the only cerebral protection system commercially available in Europe, selected Asian countries, and now, the U.S.


About Claret Medical
A privately-held company, Claret Medical develops innovative solutions for cerebral protection during structural heart and vascular interventions. The Company has been the leader in the field of cerebral protection since 2011, currently holding 97 percent market share in Europe. It is the first in the category to be commercially available in the U.S. For more information on Sentinel or the Company, please visit www.claretmedical.com.

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