Trial of Sentinel Cerebral Protection System meets primary endpoint in TAVR- Claret Medical

Claret Medical has announced the results from the SENTINEL pivotal IDE trial of the Sentinel Cerebral Protection System (CPS), used to protect patients� brains during transcatheter aortic valve replacement (TAVR). Published in Journal of the American College of Cardiology (JACC) today, the data showed that the Sentinel CPS met its primary safety endpoint and exceeded the study observational success criteria of 30 percent treatment effect. The Sentinel CPS also reduced the clinical stroke rate, eliminated peri-procedural strokes and substantially reduced embolic lesion burden, demonstrating that it can make TAVR a safer procedure. The primary safety endpoint was the occurrence of major adverse cardiac and cerebrovascular events (MACCE) at 30 days. This endpoint was met, with MACCE in the two Sentinel CPS treatment arms at 7.3 percent, significantly lower than the pre-specified performance goal of 18.3 percent (p <0.001).>

Device delivery and retrieval were accomplished safely and successfully throughout the trial at a rate of 99.6 percent. The access site complication rate was only 0.4 percent. Device deployment took less than 10 minutes in 91 percent of cases. The device captured and removed highly heterogeneous embolic debris in 99 percent of patients in the study, including valve tissue, arterial debris, calcification, thrombus and foreign material, demonstrating the need for cerebral protection in the TAVR procedure to remove brain-bound debris. The results were unveiled simultaneously as a Late Breaking Clinical Trial at Transcatheter Cardiovascular Therapeutics.