SANTA ROSA, Calif.--(BUSINESS WIRE)--Claret Medical® today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Sentinel™ Cerebral Protection ...
A device designed to remove embolic material—fragments of tissue that can be released into the bloodstream during transcatheter aortic valve replacement (TAVR)—did not result in a reduction in the ...
Debris from the proximal filter of the Sentinel system, including valve tissue, arterial wall with acute thrombus, calcification, and myocardium (Photo Credit: Aloke Finn) In a small, prospective ...
Please provide your email address to receive an email when new articles are posted on . Routine cerebral embolic protection did not reduce stroke in patients undergoing transcatheter aortic valve ...
SILVER SPRING, MD — Unanimously disappointed with the end point used to determine clinical benefit, advisors to the US Food and Drug Administration (FDA) agreed the Sentinel Cerebral Protection System ...
A device designed to remove embolic material—fragments of tissue that can be released into the bloodstream during transcatheter aortic valve replacement (TAVR)—did not result in a reduction in the ...
CHICAGO, IL—Cerebral embolic protection devices are infrequently used during transcatheter aortic valve implantation procedures in the United States, and new data suggest their use does not appear to ...
MARLBOROUGH, Mass., Sept. 17, 2022 /PRNewswire/ -- Boston Scientific Corporation (NYSE:BSX) has announced results from the PROTECTED TAVR clinical trial evaluating the SENTINEL™ Cerebral Protection ...
A US Food and Drug Administration (FDA) advisory panel struggled to muster support for marketing clearance of the TriGuard 3 (Keystone Heart) device for use during transcatheter aortic valve ...
BOSTON — In PROTECTED TAVR, the largest-ever randomized trial of transcatheter aortic valve replacement, cerebral embolic protection did not decrease incidence of periprocedural stroke. Perspective ...
Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window NEW YORK CITY -- ...
CAESAREA, Israel and TAMPA, Fla., Feb. 27, 2017 /PRNewswire/ -- Keystone Heart Ltd., an emerging medical device company focused on developing cerebral embolic protection devices for patients ...
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