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Boston Scientific Unveils ACURATE Neo2 Aortic Valve System In Europe

Boston Scientific Corp. (BSX) announced Monday that it has initiated a controlled launch of the ACURATE neo2 Aortic Valve System in Europe.

The next-generation transcatheter aortic valve implantation or TAVI technology is a new platform with additional features to improve upon the clinical performance of the original ACURATE neo platform.

The ACURATE neo2 valve system, compared to the previous generation device, also has an expanded indication for patients with aortic stenosis - with no specified age or risk level. These patients are considered appropriate candidates for the therapy by their heart team, including a cardiac surgeon.

The new system is indicated to restore function and normal blood flow through a severely narrowed aortic valve. It features a new annular sealing technology designed to conform to irregular, calcified anatomies and further minimize paravalvular regurgitation or leaking or PVL.

Joe Fitzgerald, president, Interventional Cardiology, Boston Scientific, said, "Combined with the LOTUS Edge Aortic Valve System and SENTINEL Cerebral Protection System to protect the brain against the risk of TAVI-related stroke, the ACURATE neo2 valve represents the natural evolution of our complementary dual-valve TAVI toolkit that covers the needs of a wide range of patient cases."

The ACURATE neo2 Aortic Valve System received CE Mark in April 2020. In the U.S., the system is an investigational device being assessed in the ACURATE IDE clinical trial and is not available for sale.

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