Unmet Need

Transcatheter aortic valve replacement (TAVR) has become an increasingly popular procedure for patients diagnosed with aortic stenosis who are not candidates for open-heart valve replacement surgery. As of 2017, TAVR had been performed on approximately 400,000 patients worldwide, and is rapidly expanding with an anticipated growth rate of 40% [1]. 

Despite the prevalence of TAVR, stroke remains a devastating and unsolved complication as a result of the procedure. The 30-day post-TAVR stroke rate has been reported as 2.8%, but over 80% of patients have signs of silent ischemic events or “silent strokes” which lead to poor long-term health outcomes [2].


Currently, the only FDA-approved cerebral protection device for TAVR is the SENTINEL Cerebral Protection System by Boston Scientific, which covers only two of the three great vessels coming off the aortic arch. Despite the device’s ability to capture and remove debris from the body, it did not result in a reduction in new lesion volume on MRI or strokes within 30 days compared to patients receiving no cerebral protection in its latest trial, failing to meet its overall primary efficacy endpoint [3]. Furthermore, several physicians spanning TAVR centers across the United States have cited the monetary cost of the SENTINEL device as a barrier to its use.

Amongst physicians who use the device, there is an overwhelming consensus that it should cover all three great vessels and be more intuitive to deploy. There is an urgent need for a less expensive and more effective and intuitive cerebral protection device for TAVR.

 

 

References

  1. Kourkoveli, Panagiota, et al. “TAVR in 2017-What We Know? What to Expect?” Journal of Geriatric Cardiology : JGC, Science Press, Jan. 2018.
  2. Dalby, Miles, and Vasileios Panoulas. “Transcatheter Aortic Valve Implantation: Complications.” Edited by Stephen JD Brecker and Susan B Yeon, 10 Oct. 2019.
  3. Kodali, Susheel K. “SENTINEL.” American College of Cardiology, 1 Nov. 2016.