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Frequently asked questions about cerebral embolic protection & the SENTINEL™ Cerebral Protection System

What does the SENTINEL Cerebral Protection System (CPS) do?

SENTINEL CPS works by capturing and removing embolic debris dislodged during the TAVR procedure, before it can reach the brain.

What happens to the debris if it is not collected?

When the debris from the TAVR procedure is not collected, it can travel in the bloodstream toward the brain. If the debris material reaches the brain, stroke may occur.

What is the benefit of cerebral embolic protection?

Patients who undergo TAVR with the SENTINEL CPS have a significantly higher rate of stroke-free survival than do patients who undergo TAVR without the device. In fact, SENTINEL CPS captured visible embolic debris headed toward the brain in 99% of TAVR cases.1

Is cerebral embolic protection safe?

Yes. Clinical trials involving more than 3,500 patients have demonstrated that the SENTINEL device is safe and effective. The SENTINEL cerebral protection technology has been used to protect thousands of patients worldwide and is the most-studied embolic protection device in its field.

What is left behind in cerebral embolic protection?

Nothing. Once the replacement valve is in place the SENTINEL device, along with all the debris it collected, are completely removed from the body.

Does cerebral embolic protection add to my recovery time?

No, having cerebral embolic protection will not impact your recovery time.

What are the different kinds of stroke?

A transient ischemic attack (TIA) is often called a mini stroke. It’s a brief interruption of blood flow to part of the brain, spinal cord or retina, which may cause temporary stroke-like symptoms but does not damage brain cells or cause permanent disability. Symptoms of TIA usually last only a few minutes but may persist for up to 24 hours. The risk of stroke is especially high within 48 hours after a TIA.

An ischemic stroke is the most common type of stroke. It happens when blood flow through the artery that supplies oxygen-rich blood to the brain becomes blocked. Blood clots often cause the blockages that lead to ischemic strokes. The effects of a stroke vary, and can depend on which part of the brain was injured and how long it took to get medical attention.

The most common effects from stroke include cognitive difficulties, paralysis, weakness, as well as difficulty with language, vision, and swallowing.

Is the SENTINEL device FDA approved?

Yes, it was approved on June 5, 2017.

As with any medical device, there are risks associated with use of the SENTINEL Cerebral Protection System. These risks include but are not limited to: infection, blood vessel injury, stroke, death.

Issues specific to the use of the SENTINEL have been reported in a small number of patients and typically went away in 30 days. The use of SENTINEL during yourprocedure is solely at the discretion of your doctor.

1 SENTINEL Clinical Trial