Med Device Monday: Sentinel Cerebral Protection System

Aortic stenosis is one of the most common and most serious valve disease problems. It is caused by the narrowing of the aortic valve opening, reducing the blood flow from the left ventricle to the aorta. The signs of an aortic stenosis include breathlessness, chest pain, pressure or tightness, syncope, palpitations, heart murmur, and a decline in routine physical activities. Since the heart must work harder to pump blood through the narrow valve, the wall of the left ventricle may also become thicker, resulting in a reduced space in the lower heart chamber, which can ultimately cause heart failure.

Among the treatments available for aortic stenosis, the replacement of the valve may be required. This can be done by an open heart surgery (AVR, aortic valve replacement), or via a transcatheter aortic valve replacement procedure (TAVR). Unfortunately, stroke is a major complication of these procedures, observed in 1 to 10% of the patients following surgery depending on the studies. Insufficient blood flow to the brain may be clinically apparent, or it may cause damage that has no visible neurological dysfunction, often referred to as “silent strokes”. These are associated with adverse neurological and cognitive consequences, including impaired mobility, physical decline, depression, cognitive dysfunction, and dementia. Essentially, a patient has just gone through major heart surgery and should be feeling loads better. But instead, a silent stroke might leave them feeling depressed, forgetful, or confused with no clear reason why.

As you’ve probably learned if you’ve been reading these blog posts, “There’s a device for that!” This month, FDA granted a de novo designation for the Sentinel Cerebral Protection System (CPS). The CPS is a device that filters, captures, and removes embolic debris released during valve replacement procedures. It has been shown to reduce strokes by 63% in the first 72 hours after TAVR, which is when most strokes occur. In clinical studies, CPS removed visible debris headed towards the brain in 99% of TAVR cases, regardless of replacement valve used.

From claretmedical.com

From claretmedical.com

Claret Medical explains: “Delivered through a conventional radial artery approach in the right arm, the Sentinel is a percutaneous device that utilizes a proximal embolic filter…The filters collect debris released during the procedure – valve tissue, calcification, thrombus or other material – and prevent it from traveling to the brain. At the completion of the procedure, the filters and collected debris are recaptured into the catheter and removed from the patient’s right arm.”

This is an exciting advancement in cardiac medicine. Filtering out the debris during valve replacement procedures has the amazing benefit of protecting patients from suffering a stroke after surgery. Fix the heart and protect the brain all in one fell swoop! Sounds like a win-win to me.

 

Further reading:

More About the Technology behind the Sentinel Cerebral Protection System

Sentinel Cerebral Protection System's FDA Classification Order

Using the CPS in TAVR Procedures

The CPS Procedure (includes video!)