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The Sentinel, a dual-filter embolic protection device, won FDA clearance for use during transcatheter aortic valve replacement (TAVR), manufacturer Claret Medical .

Sentinel was designed to filter out debris dislodged during the TAVR procedure so it doesn't travel up to the brain. With FDA approval via the agency's de novo classification pathway, the manufacturer will now launch the device in TAVR centers of excellence across the U.S.

Notably, the device failed to reduce major adverse events or strokes overall in the SENTINEL trial reported last year. Additionally, new lesions formed in protected brain territories were just as big as those in controls.

However, earlier this year, an FDA advisory panel still recommended approval for the device based on its low safety risk and the lack of other options.

"The 63% reduction in clinical strokes in the first 72 hours after TAVR, combined with the fact that one in four patients had an average of 25 particles of debris collected that were visible to the naked eye, is striking," Martin Leon, MD, of Columbia University Medical Center/New York-Presbyterian Hospital -- and chairman of the SENTINEL Trial Clinical Steering Committee -- said in the announcing the FDA approval. "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."

Reimbursement under Medicare and Medicaid remains to be determined.

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