Boston Scientific is no longer seeking regulatory approval of ACURATE neo2™ or ACURATE Prime™ in the United States or other countries.  This decision was made due to the increased clinical and regulatory requirements to maintain regulatory approvals in global markets and to obtain approvals in new regions.   

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.   

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

If you are an ACURATE IDE patient with an ACURATE valve and have specific questions about your clinical care, please discuss with your study doctor.