Boston Scientific Gets EU OK for Acurate Prime TAVR

Boston Scientific has received CE mark clearance for its Acurate Prime aortic valve system, its newest transcatheter aortic valve replacement (TAVR) technology.
 
Acurate Prime builds on the company’s Acurate neo2 platform with an additional valve size. It’s indicated to restore function and normal blood flow through a narrowed aortic valve in low, intermediate, and high-risk patients with severe aortic stenosis.
 
Its self-expanding, supra-annular design has an enhanced frame that equalizes force across the valve to provide a stable fit against the native, diseased valve. Acurate Prime also features a redesigned deployment mechanism for highly accurate valve position, according to Boston Scientific.
 
The valve system is available to treat aortic annulus diameters between 20.5 and 29 mm. Boston Scientific said it will begin launch of Acurate Prime in Europe in the coming weeks.
 
“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 Janar Sathananthan, MD, chief medical officer, Interventional Cardiology Therapies, Boston Scientific. “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.”
 
“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,” added Lance Bates, senior VP 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.”