Boston Sci Wins CE Mark for New TAVR System

Boston Scientific has obtained CE mark for its newest transcatheter aortic valve replacement technology.

The Marlborough, MA-based company’s Acurate Prime 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.

Boston Scientific inherited the Acurate line of TAVR valves when it acquired Symetis for $425 million in 2017.

The Acurate Prime valve system will now be available to treat 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, as well as unrestricted coronary access for future procedures.

"We are thrilled to offer physicians a new valve with meaningful improvements for the treatment of an increasing number of patients with aortic valve disease," said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. "Built on the ACURATE valve platform, which has been implanted in nearly 80,000 patients globally to date, the ACURATE Prime valve system is engineered to improve long-term cardiac function and provide access for future treatment needs, thereby supporting the lifetime management of these patients."

Related:Shareholders Punish Boston Scientific For Latest Lotus Recall

FDA has yet to approve the Acurate TAVR platform.

Boston Scientific’s TAVR journey hasn’t been easy. At one point the company’s Lotus Edge was the most watched and anticipated product in the company’s pipeline. However, Boston Scientific struggled to get the product on the market. It finally won FDA approval for the technology in 2019. Along the way there were patent scuffles with Edwards Lifesciences, challenges in Europe, and product delays.

Finally, Boston Scientific decided to retire its entire Lotus TAVR platform, citing complexities associated with the product delivery system.