While transcatheter aortic valve repair (TAVR) procedures can help avoid open heart surgeries in many fragile patients, there is a substantial risk that embolic debris is released from the calcified valves. The brain is particularly in danger, as the dislodged material can block blood vessels feeding it and result in strokes. Claret Medical out of Santa Rosa, California just received FDA clearance to introduce its Sentinel Cerebral Protection System that traps emboli and helps to prevent strokes during TAVR procedures.
The device’s two filters are delivered to the brachiocephalic artery and the left common carotid artery via a radial approach through the right arm. The TAVR procedure is performed exactly the same way as if the Sentinel was not there. As any material of large enough size comes off the valve it is captured by the filters, which following TAVR are rolled back into their catheter and removed along with the captured debris.
The Sentinel can be used during any TAVR procedure, regardless of the replacement valve that is being implanted. It takes about four minutes to deploy the filter, and, according to Claret, the device had a 99% deployment success in a clinical study.
While the device is currently indicated for TAVR cases, it’s also being evaluated for use during other minimally invasive endovascular procedures.
Here’s a short animation showing how the Sentinel is positioned and removed:
Product page: Sentinel Cerebral Protection System…
Via: Claret Medical…