Boston Scientific has officially discontinued global sales of its Acurate neo2 and Acurate Prime TAVR systems, citing escalating regulatory demands in both the U.S. and Europe.
Following regulator discussions, the company deemed the added clinical and compliance requirements prohibitively resource-intensive relative to projected returns. This marks Boston Scientific’s second major TAVR exit after discontinuing the Lotus platform five years ago.
The move comes shortly after Acurate neo2 failed to meet its primary endpoint in a head-to-head trial against Medtronic’s CoreValve Evolut, casting doubt on its competitive viability. However, registry data had shown acceptable outcomes in European centers.
Boston Scientific maintains its 2025 guidance for organic sales and adjusted EPS, though GAAP guidance is on hold until the next earnings call.
Follow MEDWIRE.AI for updates on cardiovascular devices and medtech strategy shifts.
