The FDA determined Sentinel is effective in capturing debris caused by TAVR.
The U.S. Food and Drug Administration (FDA) granted regulatory clearance to Claret Medical for Sentinel, a cerebral protection system used during transcatheter aortic-valve replacement (TAVR).
The randomized, controlled trial determined that Sentinel cut strokes by 63% in the 72 hours following TAVR, a reduction that lasted up to 90 days.
The company announced the FDA approval on Monday, June 5, in a news release, noting that the de novo classification will allow it to begin immediately distributing the system in the United States. According to Claret Medical, the device is the first of its kind, lowering risk of stroke during TAVR by snaring and removing debris introduced to the bloodstream by TAVR before it reaches the brain. This debris can include “thrombus, calcification, valve tissue, artery wall, and foreign material,” according to a recent Journal of the American College of Cardiology study.
Despite potential complications, recent studies have shown support for the procedure. A two-year study presented at the 2017 American College of Cardiology showed that TAVR was just as effective as surgical aortic valve replacement (SAVR).
“TAVR was just as good as surgery, but it was not statistically superior to it,” said Michael Reardon, MD, who presented the study at the March conference. “We saw the biggest surgical outcomes we’ve seen yet and TAVR did just as well.”
The same JACC study indicated that TAVR will cause a stroke in about 1 in 10 patients and that most strokes occur during the procedure or within 72 hours. The study concluded that transcatheter cerebral embolic protection systems, such as Sentinel, are safe and captured stroke-causing debris in 99% of patients without altering neurocognitive function.
Martin Leon, MD, the chairman of the Sentinel Trial Clinical Steering Committee, called access to the new device “extremely meaningful.”
“The 63% reduction in clinical strokes in the first 72 hours after TAVR, combined with the fact that 1 in 4 patients had an average of 25 particles of debris collected that were visible to the naked eye, is striking. The device was delivered safely, added minimal time to the procedure, and performed as intended with capture of embolic material and reduction in ischemic brain injury.”
MD Magazine writers Gale Scott and Dennis Bittner, PhD, contributed to this report.