Claret Medical® today announced several of the largest centers of excellence for transcatheter aortic valve replacement (TAVR) have now performed the first U.S. cases of protected TAVR with the newly FDA-cleared Sentinel Cerebral Protection System in the first week of commercial availability.

Cedars-Sinai in Los Angeles, Cleveland Clinic in Cleveland, Ohio, NewYork-Presbyterian in New York City, and Mount Sinai Heart in New York City are among the first centers to utilize the Sentinel to protect patients from the risk of TAVR-related procedural stroke are Other major centers, such as Emory Healthcare in Atlanta and Gates Vascular Institute in Buffalo, New York, plan cases in the coming days.

The company reports that the Sentinel is the first and only device available in the U.S. that captures and removes debris dislodged during TAVR before it can travel to the brain. Use of the Sentinel has been shown to reduce procedural related strokes by 63 percent in the first 72 hours after TAVR,1 when most strokes occur.

Samir Kapadia, MD, interventional cardiologist with the Miller Family Heart and Vascular Institute, Cleveland Clinic, Ohio on risk of stroke:  “All patients are concerned about the risk of stroke. In our conversations about treatment options, patients and their families seem reassured about having an added layer of protection during their TAVR procedure

“This device has the potential to become a standard of care for protecting patients from the risk of stroke during TAVR, just as embolic protection is commonly used for safeguarding patients during carotid stenting,” said Susheel Kodali, MD, director of the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia University Medical Center, New York City.

Raj Makkar, MD, associate director of the Interventional Technologies in the Heart Institute, Cedars-Sinai, Los Angeles added, “We have seamlessly integrated the device into our TAVR workflow as we have found it intuitive to use and fast to deploy, and it does not interfere with the TAVR procedure itself.”  He concluded, “We are now able to universally remove debris that otherwise had the potential to travel to patients’ brains. This is a meaningful step in enhancing the safety of TAVR for our patients.”

TAVR is one of the fastest growing procedures worldwide and it is estimated that close to 300,000 patients are expected to be treated by 2025 as lower risk and younger patients become eligible for the treatment. The procedure enables replacement of a diseased aortic heart valve in a minimally invasive way, but recent studies have found that almost one in 10 patients experience a clinically-apparent stroke due to the procedure.2 The majority of strokes are likely caused by debris that breaks loose from the native heart valve or aortic wall and travels towards the brain, leading to potential neurological damage.

References:

  1. Data from SENTINEL Trial, included in device’s Instructions for Use (IFU). To view the IFU, click here.
  2. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017 Jan 31; 69(4): 367-377