Boston Scientific’s Acurate Prime TAVR System Receives CE Mark Approval

August 27, 2024—Boston Scientific announced that it has received CE Mark approval for its Acurate Prime system for transcatheter aortic valve replacement (TAVR).

According to Boston Scientific, Acurate Prime builds on the company’s Acurate Neo2 platform but with extended valve sizes to accommodate patients with larger anatomy (aortic annulus diameters between 20.5 and 29 mm), enhanced valve frame, and quicker, controlled deployment.

As described in the company press release, the self-expanding, supra-annular Acurate Prime TAVR system 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.

“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,” commented Dr. Janar Sathananthan, Chief Medical Officer of Interventional Cardiology Therapies, in the press release. “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 company noted that Acurate Prime is expected to carry through clinical outcomes demonstrated with Acurate Neo2, including low pacemaker and paravalvular leak rates, strong hemodynamic performance, and unrestricted coronary access for future procedures.

Lance Bates, Senior Vice President and President, Interventional Cardiology Therapies at Boston Scientific, added, “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.”

The company expects to initiate the launch of Acurate Prime in Europe in the coming weeks. Acurate Neo2 and Acurate Prime have CE Mark approval in Europe. In the United States, the systems are investigational devices and restricted under federal law to investigational use only and not available for sale.