Boston Scientific has obtained CE mark for the Acurate Prime aortic valve system, the newest transcatheter aortic valve implantation (TAVI) 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 equalises force across the valve for a stable fit against the native, diseased valve, the company says in a press release. It also offers physicians a redesigned deployment mechanism for highly accurate valve positioning to help ensure positive patient outcomes, the press release adds.
“The introduction of the Acurate Prime technology offers physicians a TAVI option designed for streamlined procedural preparation, improved performance in complex cases and simplified delivery for quick and controlled deployment,” said Janar Sathananthan, 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.”
The Acurate Prime valve system will now be available for the treatment of aortic annulus diameters between 20.5 and 29mm.
“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.”
