Boston Scientific gets CE mark for upgraded TAVR technology

Boston Scientific has received a CE mark for Acurate Prime, its latest transcatheter aortic valve replacement (TAVR) device. This new system is an upgrade from the Neo2 valve, with a larger size that opens up access to 25% of the market previously unreachable by Neo2. Although neither Neo2 nor Prime has U.S. approval, Boston Scientific postponed its plans to seek authorization, awaiting one-year clinical trial data.

Acurate Prime offers improved features, covering aortic annulus diameters from 20.5 to 29 mm, surpassing Neo2’s 27 mm limit. It also includes a redesigned deployment system for more accurate positioning while maintaining the self-expanding design of Neo2. The device promises benefits like low pacemaker and paravalvular leak rates, excellent hemodynamic performance, and unrestricted coronary access.

Boston Scientific plans to launch Acurate Prime in Europe soon, with U.S. approval expected after further trial results in 2025.