Boston Scientific discontinuing worldwide sales of ACURATE Aortic Valve Systems

In a regulatory filing, Boston Scientific (BSX) disclosed that it announced it is discontinuing worldwide sales of the ACURATE neo2 and ACURATE Prime Aortic Valve Systems and no longer pursuing U.S. FDA approval for ACURATE or approval in other geographies. “The company made this decision based on recent discussions with regulators, which resulted in increased clinical and regulatory requirements to maintain regulatory approvals in global markets and to obtain approvals in new regions. The additional resources and investments needed to satisfy these requirements are prohibitive for the company. Based on the information known today and despite the anticipated financial impacts from the discontinuation of ACURATE, the company expects to achieve its second quarter and full year 2025 reported and organic sales and adjusted earnings per share guidance issued on April 23, 2025. The company is not reaffirming its second quarter and full year 2025 GAAP EPS guidance issued on April 23, 2025 at this time and expects to provide more information during the company’s second quarter 2025 earnings call,” Boston Scientific stated in the filing. In pre-market trading, Boston Scientific shares have slipped 84c, or about 1%, to $105.33, while shares of Edwards Lifesciences (EW) are up $1.68, or 2%, to $77.90.