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Boston Scientific Corporation has announced that it has received the CE mark for the ACURATE Prime™ Aortic Valve System, the latest addition to its transcatheter aortic valve replacement (TAVR) technologies within the structural heart portfolio. The ACURATE Prime valve system builds on the clinical performance of the ACURATE neo2™ platform with several enhancements, including an extra valve size that extends treatment options to patients with larger anatomies.

The new ACURATE Prime valve system is intended to restore function and normal blood flow through a narrowed aortic valve in patients with severe aortic stenosis, ranging from low to high risk. Featuring a self-expanding, supra-annular design, the system includes an upgraded frame that balances force across the valve for a secure fit against the diseased native valve. It also provides physicians with a redesigned deployment mechanism for precise valve positioning, aiming to improve 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 treating aortic annulus diameters between 20.5 and 29 mm. It incorporates many of the design features and clinical outcomes demonstrated in global studies with the ACURATE neo2 platform, such as low rates of pacemaker implantation and paravalvular leak, 1,2  robust hemodynamic performance,1 and unrestricted coronary access for potential 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.”

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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