Boston Scientific Halts Acurate TAVR Sales Over Regulatory Struggles

Boston Scientific is ceasing sales of its Acurate neo2 and Acurate Prime aortic valve systems.

The company also said in an SEC filing that it’s no longer seeking U.S. Food and Drug Administration (FDA) approval for the Acurate portfolio, or approval in other geographies.

Boston Scientific said this decision arose due to recent discussions with regulators, which resulted in more stringent clinical and regulatory requirements to maintain approvals in global markets and gain approvals in new regions. The company said the resources and investments needed to satisfy the requirements were “prohibitive for the company.”

The company has been working to compete in the lucrative transcatheter aortic valve replacement (TAVR) market for some time. It gained FDA approval for the Lotus Edge TAVR in April 2019, rolled out Acurate neo2 in Europe in September 2020, and obtained a CE mark for Acurate Prime in August 2024.

However, these wins were short-lived. The Acurate neo valve failed to demonstrate non-inferiority compared to Medtronic’s CoreValve Evolut valves in the SCOPE II study. The Lotus Edge aortic valve was pulled from the market over issues with its delivery system a month later.

The final blow was a recent clinical trial the company funded comparing the next-generate Acurate neo2 TAVR to Medtronic’s Evolut and Edwards’ Sapien TAVRs, which showed Acurate neo2 didn’t meet the predetermined non-inferiority margin.

Boston Scientific said in the SEC filing that it still plans to achieve Q2 and full-year 2025 sales per its share guidance. It’s not reaffirming Q2 and full-year 2025 GAAP EPS guidance and will provide more information in its Q2 earnings call.