The company said it is discontinuing worldwide sales of the ACURATE neoneo2 and ACURATE Prime Aortic Valve Systems as of May 28, 2025 and will no longer pursue U.S. FDA approval for ACURATE or approval in other geographies.

1. 01

   The company said it is discontinuing worldwide sales of the ACURATE neoneo2 and ACURATE Prime Aortic Valve Systems as of May 28, 2025 and will no longer pursue U.S. FDA approval for ACURATE or approval in other geographies.

2. 02

   Boston Scientific said regulators' recent discussions resulted in higher clinical and regulatory requirements to maintain approvals in global markets and to obtain approvals in new regions. It said the additional resources and investments needed to meet these requirements are prohibitive for the company.

3. 03

   The company said that, despite the expected financial impacts from the ACURATE discontinuation, it expects to achieve its Q2 and full-year reported and organic sales and adjusted earnings per share outlook it issued on April 23, 2025, based on information known today.

4. 04

   Boston Scientific said it is not reaffirming its Q2 and full-year GAAP EPS outlook issued on April 23, 2025 at this time. It said it expects to provide more information on the Q2 earnings call.

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Original filing

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