Boston Scientific (NYSE:BSX) shares fell 4% after the company announced it will discontinue global sales of its ACURATE neo2 and ACURATE Prime Aortic Valve Systems. The decision follows discussions with regulatory agencies that resulted in stricter clinical and compliance requirements.
On May 28, 2025, the company said the heightened regulatory demands would require resources and investment it deems unjustifiable. As a result, Boston Scientific is also dropping its pursuit of FDA approval in the U.S. and regulatory clearance in other regions.
Despite the product withdrawal, the company still expects to achieve its previously issued guidance for Q2 and full-year 2025, covering reported and organic sales as well as adjusted earnings per share. This guidance was originally provided on April 23, 2025. However, Boston Scientific noted it is not reaffirming its GAAP EPS forecast at this time and plans to provide more information during its Q2 2025 earnings call.