Claret Medical touts Sentinel data in TAVR study

Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates. The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so. “In patients undergoing TAVR, use of (the Sentinel) cerebral embolic protection device demonstrated a significantly higher rate of stroke-free survival compared with unprotected TAVR…In addition, there are no safety issues with use of the protection device…Hence, cerebral embolic protection should become standard of care for the TAVR procedure, as there are no pre-procedural independent predictors identified for selection of patients at high risk for stroke,” study authors wrote. The real-world, all-comers study was conducted at Germany’s University of Ulm and examined a total of 802 consecutive TAVR patients, with 280 of the group protected by the Sentinel. Patients treated with the Sentinel were reported to have a 2.1% rate of all-cause mortality or all-stroke at 7 days, versus 6.8% for patients not treated with Sentinel. “Stroke risk with T...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news