U.S. Pivotal IDE Trial Confirms Effectiveness of Sentinel Cerebral Protection System During TAVI

Published in Journal of the American College of Cardiology (JACC) and simultaneously unveiled at Transcatheter Cardiovascular Therapeutics (TCT) 2016, are results from the Claret Medical® SENTINEL pivotal IDE trial of the Sentinel® Cerebral Protection System (CPS). Used to protect patients’ brains during transcatheter aortic valve replacement (TAVR), the primary safety endpoints were met and exceeded the study observational success criteria of 30 percent treatment effect. The system 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, says the manufacturer.

Background

TAVR is considered the gold standard in treating high-risk aortic stenosis patients, yet stroke remains a relatively high risk complication, occurring in 9.1% of patients.

Claret Medical’s Sentinel CPS is the only device designed to protect the brain by capturing and removing debris dislodged during TAVR that would otherwise enter the cerebral circulation and increase the potential for stroke. It is the most-studied device in the field of TAVR cerebral protection, having been systematically evaluated in three randomized controlled trials involving more than 750 patients. More than 3,000 patients worldwide have been treated with the device to-date.

In the newly presented study, use of the Sentinel CPS substantially cut the stroke rate by 39 percent, to 5.6 percent. Importantly, unprotected patients in the control group experienced seven peri-procedural strokes, while there were none in the treatment arm protected by the Sentinel CPS (p= 0.002).

The results were unveiled simultaneously as a Late Breaking Clinical Trial at TCT 2016, the annual scientific symposium of the Cardiovascular Research Foundation. The results were presented by national co-primary investigator Susheel Kodali, MD, of Columbia University Medical Center/New York-Presbyterian Hospital on behalf of his co-primary investigators, Samir Kapadia, MD, of The Cleveland Clinic, and Prof. Axel Linke, of The University of Leipzig, Germany.

Investigator comments

“The SENTINEL study showed unequivocal evidence of device safety and performance, and confirmed the high frequency of embolic debris capture by the Sentinel,” said Dr. Kodali. “It also demonstrated that the device is compatible with standard cath lab workflow, with virtually no interference with the primary TAVR procedure and minimal time needed for deployment.”

“This study shows us that TAVR-generated brain lesions matter when assessing patient outcomes after TAVR, and that the Sentinel device reduced both clinical neurologic events and neuroimaging evidence of brain embolization,” said Martin Leon, MD, of Columbia University Medical Center/New York-Presbyterian Hospital and founder of the Cardiovascular Research Foundation. “It is also interesting to note that the strokes that did occur in the trial appeared to be less severe when the Sentinel device was used.”

“The SENTINEL study has, for the first time, revealed a strong link between frequency and size of new brain lesions, and neurocognitive deterioration post-TAVR,” said Ronald M. Lazar, PhD, of the Tananbaum Stroke Center, Neurological Institute, Columbia University Medical Center.

Company comments

“We are gratified that our commitment to science and clinical trial excellence has enabled us to make TAVR a safer procedure and shed light on an important new risk factor in further validating the role of cerebral protection in TAVR,” said Claret Medical President and Chief Executive Officer Azin Parhizgar. “Following our recent marketing application submission, we look forward to working with the FDA to make the Sentinel CPS available to American physicians and their patients who want protection during TAVR.”

Source: Claret Medical

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