News | Embolic Protection Devices | September 20, 2016

Claret Medical Submits for U.S. Clearance of TAVR Cerebral Protection System

Filing based on data from the SENTINEL pivotal IDE trial

Claret Medical, Sentinal CPS, cerebral protection system, FDA marketing application, TAVR, embolic protection

September 20, 2016 – Claret Medical announced its filing of a marketing application with the U.S. Food and Drug Administration (FDA) for clearance of the Sentinel Cerebral Protection System (CPS). The Sentinel CPS is designed to protect the brain by capturing and removing debris dislodged during transcatheter aortic valve replacement (TAVR) that enters cerebral circulation and carries the potential for stroke. There are currently no cerebral embolic protection technologies available in the United States to protect TAVR patients from cerebral embolic events, according to Claret Medical.

The filing includes data from the recently completed SENTINEL pivotal investigational device exemption (IDE) trial, a prospective, randomized, controlled, blinded study of 363 TAVR patients at 19 centers in the United States and Germany. Trial endpoints included reduction in new ischemic cerebral infarcts, major adverse cardiac or cerebrovascular events, neurocognitive outcomes, and qualitative and quantitative histopathological findings. The SENTINEL trial allowed inclusion of all commercially available TAVR platforms available in the U.S.

Results from the recently published CLEAN-TAVI blinded, randomized, controlled trial in the Journal of the American Medical Association (JAMA) and the MISTRAL-C randomized, controlled trial, published in Eurointervention, showed that patients protected with the system had significantly fewer and smaller new ischemic cerebral infarcts following the procedure than unprotected patients. MISTRAL-C also demonstrated that the TAVR procedure created embolic debris in 100 percent of patients, which could have traveled to the brain if not for the protection offered by the Sentinel CPS.

Stroke continues to be a devastating complication of TAVR and other endovascular procedures. Ischemic brain infarcts have been associated with adverse neurologic and cognitive consequences, as well as dementia. In population-based studies, they have also been shown to increase the risk of future stroke by two- to four-fold.

The Sentinel CPS received the CE Mark in 2013.

For more information: www.claretmedical.com

Related Content

Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Overlay Init