Marlborough, Massachusetts-based Boston Scientific designed Acurate Prime with several features to build upon the clinical performance of the Acurate neo2 platform. It has additional valve sizes to expand the treatment range to patients with a larger anatomy.
The new TAVR 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. Acurate Prime is self-expanding and has a supra-annular design. Its enhanced frame equalizes force across the valve for a stable fit against the native, diseased valve.
“The introduction of the Acurate Prime technology offers physicians a TAVR option designed for streamlined procedural preparation, improved performance in complex cases and simplified delivery for quick and controlled deployment,” said Chief Medical Officer of Interventional Cardiology Therapies Dr. Janar Sathananthan. “Further, our clinical experience with the valve to date has shown the ability for precise positioning of the device in a broader population of patients, allowing more clinicians to consider this technology for treatment in challenging or larger heart structures.”
Boston Scientific said the Acurate Prime valve system will be available to treat aortic annulus diameters between 20.5 and 29 mm. The TAVR system will also carry through many of the design features and clinical outcomes in global studies with Acurate neo2, including low pacemaker and paravalvular leak rates, strong hemodynamic performance and unrestricted coronary access for future procedures, according to the company.
“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 of Interventional Cardiology Therapies at 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.”
The Acurate neo2 Aortic Valve System and the Acurate Prime Aortic Valve System are CE-marked in Europe. However, the two devices are investigational in the U.S. and are restricted to investigational use only under federal law.
