Boston Scientific obtains CE Mark for ACURATE prime aortic valve system

Boston Scientific Corporation announced it has obtained CE mark for the ACURATE Prime Aortic Valve System, the latest transcatheter aortic valve replacement (TAVR) technology in the company's structural heart portfolio. The ACURATE Prime valve system is designed with several features to build upon the clinical performance of the ACURATE neo2 platform including an additional valve size, which expands the treatment range to patients with a larger anatomy.

The new ACURATE Prime valve system is indicated to restore function and normal blood flow through a narrowed aortic valve in low, intermediate and high-risk patients with severe aortic stenosis. With a self-expanding, supra-annular design, this device has an enhanced frame that equalizes force across the valve for a stable fit against the native, diseased valve. It also offers physicians a redesigned deployment mechanism for highly accurate valve positioning to help ensure positive patient outcomes.

The ACURATE Prime valve system will now be available for the treatment of aortic annulus diameters between 20.5 and 29 mm. It will also carry through many of the design features and clinical outcomes demonstrated in global studies with the ACURATE neo2 platform, including low pacemaker and paravalvular leak rates, strong hemodynamic performance,¹ as well as unrestricted coronary access for future procedures.

The company will initiate the launch of the ACURATE Prime valve system in Europe in the coming weeks.