波士顿科学公司撤下主动脉瓣系统，Edwards Lifesciences和美敦力获胜

Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT) trended higher in the premarket on Wednesday after their rival heart valve maker Boston Scientific (NYSE:BSX) decided to discontinue global sales of its ACURATE neo2 and ACURATE Prime aortic valve systems following regulatory feedback.

Boston Scientific (NYSE:BSX) said that it would no longer seek regulatory nod for ACURATE in the U.S. or elsewhere after health authorities indicated rougher clinical and regulatory requirements to maintain approvals for ACURATE in existing markets and seek approvals in new regions.

A decision came after a recent study published in The Lancet showed that ACURATE neo2 failed to meet the non-inferiority endpoint in a randomized trial designed to evaluate it against rival heart valves, Sapien 3 and Evolut from Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT), respectively.

“The additional resources and investments needed to satisfy these requirements are prohibitive for the company,” Boston Scientific (NYSE:BSX) said in an SEC filing.

The company added that despite the financial impact of the decision, it maintains its previously issued outlook for reported and organic sales as well as adjusted earnings per share for Q2 2025 and the full year. However, BSX is not reiterating its Q2 and full-year outlook for GAAP earnings per share.