Boston Scientific launches ACURATE neo2 aortic valve system in Europe.

Boston Scientific Corporation announced it has initiated a controlled launch of the ACURATE neo2 Aortic Valve System in Europe. This next-generation transcatheter aortic valve implantation (TAVI) technology is a new platform designed with a number of features to improve upon the clinical performance of the original ACURATE neo platform. Compared to the previous generation device, the ACURATE neo2 valve system also has an expanded indication for patients with aortic stenosis – with no specified age or risk level – who are considered appropriate candidates for the therapy by their heart team, including a cardiac surgeon. Data from the ACURATE neo2 CE-Mark Study demonstrated PVL (paravalvular regurgitation or leaking) rates for the ACURATE neo2 Valve System to be lower than previously reported with the current generation ACURATE neo valve. At 30 days and 1 year after implantation, respectively, 97% and 97.5% of patients experienced no/trace or mild PVL, 3.0% and 2.5% of patients experienced moderate PVL and 0% of patients experienced severe PVL. The ACURATE neo2 Aortic Valve System received CE Mark in April 2020. In the U.S., the ACURATE neo2 Valve System is an investigational device being assessed in the ACURATE IDE clinical trial and is not available for sale.