Boston Scientific Corporation tells us it has obtained CE mark for the ACURATE Prime™ Aortic Valve System. Indeed it is the newest transcatheter aortic valve replacement (TAVR) technology in the company’s structural heart portfolio.
Acurate Prime™ Aortic Valve System
Boston Scientific’s new 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. This ensures a stable fit against the native, diseased valve. It also features a redesigned deployment mechanism for highly accurate valve positioning.
Boston Scientific designed the ACURATE Prime valve system to build upon the clinical performance of the ACURATE neo2™ platform. Features include an additional valve size, which expands the treatment range to patients with a larger anatomy.
The ACURATE Prime valve system will now be available for 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. Moreover these include low pacemaker and paravalvular leak rates and strong hemodynamic performance. In addition it permits unrestricted coronary access for future procedures.
Company comments
Janar Sathananthan, M.D., is Boston Scientific’s chief medical officer, Interventional Cardiology Therapies. He comments; “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. Furthermore, our clinical experience with the valve to date has shown the ability for precise positioning of the device in a broader population of patients. This allows more clinicians to consider this technology for treatment in challenging or larger heart structures.”
Lance Bates is Boston Scientific’s senior vice president and president, Interventional Cardiology Therapies. He states; “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.”
The company will initiate the launch of the ACURATE Prime valve system in Europe in the coming weeks. Find more information on the system here.
Source: PR Newswire, Boston Scientific
published: August 28, 2024 in: Approval/Clearance, Boston Scientific, Cardio
