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ITAL-neo Registry: Boston Scientific's ACURATE neo2 Valve Significantly Reduces Paravalvular Leak (PVL) from 1st Generation Device
Increasing the Size of the Outer Pericardial Skirt Reduced PVL Three-Fold
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Dr. Andrea Buono presenting ITAL-neo at EuroPCR 2022 |
May 18, 2022 -- On the first day of this year's EuroPCR meeting in Paris, Dr. Andrea Buono of Fondazione Poliambulanza Istituto Ospedaliero in Brescia, Italy, presented the 90-day results from the ITAL-neo registry, a retrospective observational multi-center study, comparing outcomes from Boston Scientific's first generation ACURATE neo transcatheter aortic valve replacement (TAVR) system with those from the newer ACURATE neo2 device. The results were published simultaneously in JACC: Cardiovascular Interventions.
ACURATE neo2™ Aortic Valve System |
Boston Scientific's first generation self-expanding TAVR was originally approved for use in Europe in 2014. One issue was that it exhibited a not insignificant moderate or greater paravalvular leak (PVL).
So the company added a taller external skirt for the newer device. And, as Drs. Kim and Mφllmann wrote in their accompanying editorial, "A Tiny Detail With Considerable Impact,"
the results basically solved that issue. The PVL was reduced from 11.2% down to 3.5%.
Whether or not this "fix" will make the ACURATE neo2 approvable by the U.S. F.D.A. and competitive with the current generation of TAVR valves available in the U.S. is the subject of a clinical trial currently enrolling patients: the ACURATE IDE which will measure the neo2's performance against Medtronic's CoreValve and Edwards' SAPIEN 3 TAVR Systems.
Reported by Burt Cohen, May 18, 2022
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