The Sentinel Cerebral Protection System (CPS)
The only FDA-cleared device available in the U.S. to protect patients from the risk of stroke during TAVR
The Sentinel Cerebral Protection System (CPS) is a unique device that filters, captures and removes embolic debris released during TAVR, and is the technology behind “Protected TAVR.” It has been shown to reduce strokes by 63% in the first 72 hours after TAVR – when most strokes occur.1 In clinical studies, the Sentinel removed visible debris headed towards the brain in 99% of TAVR cases,2 regardless of replacement valve used and with virtually no added risk. The Sentinel can be used safely with any commercially available TAVR valve.
The Sentinel is simple to use, with 99% deployment success in a median deployment time of four minutes.3 It is securely positioned away from the aortic arch, avoiding damage to the arch, minimizing interference with TAVR catheters, and enabling physicians to focus solely on the TAVR procedure.
The Sentinel is also being studied in other endovascular procedures, such as thoracic endovascular aneurysm repair (TEVAR), left atrial appendage occlusion (LAAO), valve-in-valve (VinV) and transcatheter mitral valve repair and replacement.
Large embolic debris removed after TAVR
“The results seen with the Claret Medical system are striking. They clearly show that by removing embolic debris from cerebral circulation when performing TAVI we can dramatically reduce both the quantity and volume of brain lesions.”
Axel Linke, MD, Professor of Preventative and Regenerative Cardiology, University Leipzig Heart Center, Leipzig, Germany
“Any occurrence of stroke is one too many. By both capturing and removing embolic debris released during TAVI, the Sentinel may offer a unique neuro-protective benefit.”
Samir Kapadia, MD, Director of Cardiovascular Medicine, Cleveland Clinic Foundation, and Co-Principal Investigator for the SENTINEL trial
About The Technology
The Sentinel consists of a 6 French-compatible catheter with deployable proximal and distal filters, an articulating sheath and an integral handle assembly. Precisely located radiopaque markers enable visualization under fluoroscopy during use. Using the articulating sheath, the curve of the device can be adjusted to accommodate anatomic variations of the aortic arch. The Sentinel is available in one universal size that adjusts to the vast majority of vascular anatomies.
- Data from SENTINEL Trial, included in device’s Instructions for Use (IFU). To view IFU, click here.
- Van Mieghem, et al. EuroIntervention, 2016
- Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Click here for the Indication, Contraindications, Warnings, and Precautions.