The ACURATE IDE clinical study is conducted to evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

As of May 2025, Boston Scientific Corporation (BSC) announced the voluntary global discontinuation of the ACURATE product platform, including both the ACURATE neo2™ and ACURATE Prime™ Aortic Valve Systems. BSC will no longer pursue regulatory approval for the device in the U.S.or other unapproved geographies.

Patients who have been treated with an ACURATE neo2™ valve or ACURATE Prime XL valve as part of the ACURATE IDE clinical trial should continue with their study follow-up care. Please contact your study doctor if you have any questions.

For Investigators that would like more information, please contact the Boston Scientific ACURATE IDE study team.