TCTMD

Sentinel Cerebral Protection Device in TAVR ‘Promising’ but Trial Misses Primary Endpoint

WASHINGTON, DC—Cerebral protection during transcatheter aortic valve replacement using the Sentinel filter device (Claret Medical) is safe and appears to trap embolic debris in almost every single ...
Medscape

Sentinel Embolic-Protection Device at TAVR Fails to Show Brain Benefit

WASHINGTON, DC — Are surrogate end points enough to recommend a treatment that seems safe but hasn't "worked" by clinical-trial standards, but many agree ought to work? A pair of catheter-delivered ...
TCTMD

Sentinel Cerebral Embolic Protection Device Acquired by Boston Scientific

The manufacturer of two transcatheter aortic valve technologies that have yet to get US Food and Drug Administration (FDA) clearance announced today that it plans to purchase the company that makes ...
Business Wire

Claret Medical Receives FDA Clearance to Market Sentinel Cerebral Protection System in the U.S.

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 ...
Business Wire

Results from U.S. Pivotal IDE Trial Show That Sentinel Cerebral Protection System Protects Patients During Transcatheter Aortic Valve Replacement

WASHINGTON & SANTA ROSA, Calif.--(BUSINESS WIRE)--Claret Medical® today announced the results from the SENTINEL pivotal IDE trial of the Sentinel® Cerebral Protection System (CPS), used to protect ...
FierceBiotech

FDA clears Claret Medical’s Sentinel TAVR stroke protection device for U.S. market

The FDA has cleared the use of Claret Medical’s Sentinel cerebral protection system in the U.S., making the device the first and only of its kind on the market that reduces the risk of stroke by ...