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Sentinel® Embolic Protection System

Sentinel® is the only device approved to protect patients against the risk of stroke during RVAP, a minimally invasive procedure to replace the aortic valve in patients with severe aortic stenosis. Embolic debris, such as calcium or tissue, can become dislodged during the procedure, travel through the bloodstream to the brain, and potentially cause neurological and neurocognitive damage.


Sentinel CPS, administered through a conventional radial artery approach in the right arm, is a percutaneous device that uses a proximal embolic filter delivered to the brachiocephalic artery and a distal embolic filter delivered to the left common carotid artery at the start of the TAVI procedure. . Filters collect debris released during the procedure (valve tissue, calcification, thrombus, or other material) and prevent debris from traveling to the brain. At the end of the procedure, the filters and collected debris are captured back into the catheter and removed from the patient's right arm.


Sentinel consists of a 6F catheter compatible with deployable proximal and distal filters, an articulated sleeve, and an integral handle assembly. Precisely located radiopaque markers allow visualization under fluoroscopy during use. Using the articulated sheath, the curve of the device can be adjusted to accommodate anatomical variations in the aortic arch. Sentinel CPS is available in a universal size to fit the vast majority of vascular anatomies.


Sentinel CPS is different from other cerebral embolic protection devices still in development because Sentinel is safely positioned away from the aortic arch, thus avoiding damage to the arch, minimizing interference with TAVI catheters, and allowing clinicians to focus solely on the TAVI procedure. .
Sentinel has intraluminal filters that provide markedly different clinical benefits than baffles and devices placed in the aortic arch that can interfere with TAVI cannulation, scrape the wall of the calcified aorta, and may have problems maintaining seal and stability within the arch. .
However, Sentinel CPS is the only non-calcified arch protection device that leverages an approximately twenty-year legacy of safety and efficacy of carotid filters. Not only is the Sentinel CPS not inconspicuous, as it leaves the arch free for the passage of the TAVI device, the Sentinel device is designed to remain securely in place throughout the procedure due to its self-expanding design with circumferential sealing.

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