Boston Scientific presents ACURATE neo2 data at TCT 2024

Boston Scientific (BSX) Corporation announced the results of the primary endpoint of the ACURATE IDE clinical trial, which evaluated the ACURATE neo2 Aortic Valve System in the treatment of patients with severe, symptomatic aortic stenosis at low, intermediate, high and extreme risk of open-heart surgery. The data were presented as a late-breaking clinical trial at Transcatheter Cardiovascular Therapeutics 2024, the annual scientific symposium of the Cardiovascular Research Foundation. This randomized trial evaluated the ACURATE neo2 valve, the company’s second-generation transcatheter aortic valve replacement technology, versus a pre-defined control valve, either the commercially available SAPIEN valve or the Evolut transcatheter aortic valve system, selected at the discretion of the implanting physician. The composite rate of all-cause mortality, stroke or rehospitalization at one year was 16.16% in the ACURATE neo2 arm and 9.53% in the control arm, not meeting the prespecified criterion for non-inferiority. Also presented in the late-breaking session were data from a post-hoc analysis to identify and evaluate expanded and under-expanded ACURATE neo2 valve frames within the ACURATE IDE trial. The company performed a review of key procedural factors, including pre- and post-dilation, which helps to prepare for, enable and confirm proper valve expansion during the procedure. Following this review, an assessment of implant quality for the ACURATE neo2 valve was initiated and highlighted that approximately 20% of the valves were under-expanded. Data from the assessment also demonstrated that the rate for death, stroke or rehospitalization at one year was similar between the ACURATE neo2 expanded group and the control group. Boston Scientific continues to work closely with the U.S. Food and Drug Administration on the regulatory strategy for approval of the ACURATE valve platform in the U.S.