Boston Scientific has received the CE mark for Acurate Prime aortic valve system, a transcatheter aortic valve replacement (TAVR) system for people with severe aortic stenosis.
Acurate Prime builds upon the Acurate neo2 platform with several new features, including additional valve size, which expands the treatment range to patients with a larger anatomy.
The new aortic 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.
It comes with a self-expanding, supra-annular design, and features an enhanced frame that equally distributes force across the valve for a stable fit against the native, diseased valve.
The new valve system also offers a redesigned deployment mechanism for accurate valve positioning to ensure positive patient outcomes, said the US medical technology company.
Boston Scientific interventional cardiology therapies chief medical officer Janar Sathananthan said: “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.
“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 is offering the Acurate Prime valve system for the treatment of aortic annulus diameters, ranging between 20.5 and 29mm.
The system also carries several design features and clinical outcomes, as shown with the Acurate neo2 platform in clinical studies worldwide.
The outcomes include low pacemaker and paravalvular leak rates, strong hemodynamic performance, and unrestricted coronary access for future procedures.
The medical technology company intends to start commercialising the Acurate Prime valve system in Europe, within a few weeks.
Boston Scientific senior vice president and interventional cardiology therapies president Lance Bates said: “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.
“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.”
