Boston Scientific Corporation Discontinues ACURATE Valve Systems Amid Regulatory Challenges

Reuters
28 May
Boston Scientific Corporation Discontinues ACURATE Valve Systems Amid Regulatory Challenges

On May 28, 2025, Boston Scientific Corporation announced its decision to discontinue worldwide sales of its ACURATE neo2™ and ACURATE Prime™ Aortic Valve Systems. The company will also no longer pursue U.S. FDA approval or seek approval in other regions. This decision follows recent discussions with regulators that have led to increased clinical and regulatory requirements. The company determined that the resources and investments necessary to meet these new requirements are prohibitive. Despite the anticipated financial impact of discontinuing ACURATE, Boston Scientific still expects to meet its second quarter and full year 2025 sales and adjusted earnings per share guidance. However, the company has not reaffirmed its GAAP EPS guidance for the same period and plans to provide more information in its second quarter 2025 earnings call.

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