The Investor
29 May 2025, 09:40
Boston Scientific Discontinues ACURATE Valve Systems Amid Regulatory Hurdles
Boston Scientific Corporation announced it will cease global sales of its ACURATE neo2™ and ACURATE Prime™ Aortic Valve Systems and withdraw efforts to obtain FDA approval in the U.S. and other markets. The decision follows discussions with regulators that introduced higher clinical and regulatory requirements, making continued investment in the product line prohibitively costly.
Despite this move, the company expects to meet its Q2 and full-year 2025 sales and adjusted EPS guidance, as issued in April. However, it is not reaffirming its GAAP EPS guidance at this time and will provide further updates in its Q2 earnings call.
The announcement includes forward-looking statements and cautions investors that actual outcomes may vary due to market, operational, regulatory, or geopolitical factors.
Boston Scientific Corporation announced it will cease global sales of its ACURATE neo2™ and ACURATE Prime™ Aortic Valve Systems and withdraw efforts to obtain FDA approval in the U.S. and other markets. The decision follows discussions with regulators that introduced higher clinical and regulatory requirements, making continued investment in the product line prohibitively costly.
Despite this move, the company expects to meet its Q2 and full-year 2025 sales and adjusted EPS guidance, as issued in April. However, it is not reaffirming its GAAP EPS guidance at this time and will provide further updates in its Q2 earnings call.
The announcement includes forward-looking statements and cautions investors that actual outcomes may vary due to market, operational, regulatory, or geopolitical factors.
