Boston Scientific Discontinues Acurate Neo2 and Acurate Prime TAVR Systems

May 28, 2025—Boston Scientific announced it is discontinuing worldwide sales of the Acurate Neo2 and Acurate Prime transcatheter aortic valve replacement (TAVR) systems. Related commercial, clinical, research and development, and manufacturing activities will cease, advised the company.

The company stated that data continue to support the performance of the Acurate valve system when the product’s optimized instructions for use are followed.

However, this decision was made based on recent discussions with regulators that resulted in increased clinical and regulatory requirements to maintain approvals in global markets and to obtain approval in new markets, stated Boston Scientific.

The action was first disclosed by the company on May 28 in a Form 8-K filing with the US Securities and Exchange Commission.

As noted in recent company announcements, the Acurate Neo2 and the Acurate Prime TAVR systems have been investigational devices in the United States, restricted under federal law to investigational use only.

In Europe, both the Acurate Neo2 and the Acurate Prime received CE Mark approval.

In August 2024, Boston Scientific announced CE Mark approval for the Acurate Prime system. At EuroPCR 2025, findings were presented from the large, real-world Early ACURATE PRIME Registry.

In October 2024, the results of the primary endpoint of the ACURATE investigational device exemption clinical trial evaluating the Acurate Neo2 system at sites in the United States and Canada were presented at TCT 2024.

The Acurate line of TAVR devices was developed by Switzerland-based Symetis SA, which Boston Scientific acquired in 2017. The first-generation Acurate Neo received CE Mark approval and was launched in Europe by Symetis in 2014.