Boston Scientific’s Early ACURATE PRIME Registry Data Presented

May 27, 2025—Boston Scientific recently announced data from the Early ACURATE PRIME Registry, which is evaluating the Acurate Prime aortic valve system. Boston Scientific noted that the findings are the first large, real-world clinical data on the company’s latest transcatheter aortic valve replacement (TAVR) device after its approval and launch in Europe last year.

On August 27, 2024, the company announced CE Mark approval of the self-expanding, supra-annular Acurate Prime TAVR system, which is indicated for restoring function and normal blood flow through the narrowed aortic valve in low-, intermediate-, and high-risk patients with severe aortic stenosis.

Andreas Rück, MD, who is Head of the Transcatheter Aortic Valve Implantation program at Karolinska University Hospital in Stockholm, Sweden, presented the registry data at the EuroPCR 2025 conference held May 20-23 in Paris, France.

According to Boston Scientific, key findings from the registry, which is composed of 517 patients at 12 sites in Europe, include the following:

• Technical success rate of 98.6%
• Thirty-day device success rate of 96.4%
• Overall new permanent pacemaker implantation rate of 9.8%
• Thirty-day postimplantation aortic valve area of 2.6 cm²

Additionally, Dr. Rück reported favorable core-lab adjudicated hemodynamic results at 30 days with a 1.2% rate of severe or moderate paravalvular leakage and an aortic mean gradient of 7.2 mm Hg, noted the company’s press release.

UPDATE: On May 28, 2025, Boston Scientific announced it is discontinuing worldwide sales of the Acurate Neo2 and Acurate Prime TAVR systems. Related commercial, clinical, research and development, and manufacturing activities will cease. Read more here.