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Boston Scientific Obtains CE Mark for ACURATE Prime Aortic Valve System
Boston Scientific News
MARLBOROUGH, Mass.-- Boston Scientific Corporation announced it has obtained CE mark for the ACURATE Prime™ Aortic Valve System, the newest transcatheter aortic valve replacement (TAVR) 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 equalizes force across the valve for a stable fit against the native, diseased valve. It also offers physicians a redesigned deployment mechanism for highly accurate valve positioning to help ensure positive patient outcomes.
"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, M.D., 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 29 mm. It will also carry through many of the design features and clinical outcomes demonstrated in global studies with the ACURATE neo2 platform, including low pacemaker and paravalvular leak rates,1,2 strong hemodynamic performance,1 as well as unrestricted coronary access for future procedures.
"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."
The company will initiate the launch of the ACURATE Prime valve system in Europe in the coming weeks. For more information on the system, visit https://www.bostonscientific.com/en-EU/medical-specialties/structural-heart/tavi-acurate-prime.html.
*In Europe, the ACURATE neo2™ Aortic Valve System and the ACURATE Prime™ Aortic Valve System are CE-marked. In the USA, the ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are investigational devices and are restricted under federal law to investigational use only. Not available for sale.
1 Rück A, Kim WK, Abdel-Wahab M, et al. The Early neo2 Registry: Transcatheter Aortic Valve Implantation with ACURATE neo2 in a European Population. J Am Heart Assoc. 2023 Aug;12(15):e029464.
2 Kim WK, Tamburino C, Möllmann H, et al. Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study. EuroIntervention. 2023 May 12;19(1):83-92.
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