On Wednesday, Boston Scientific Corporation (NYSE:BSX) released the results of the primary endpoint of the ACURATE IDE trial of ACURATE neo2 Aortic Valve System for patients with severe, symptomatic aortic stenosis at risk of open-heart surgery.

The data were presented 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 (TAVR) technology, versus a pre-defined control valve, either the commercially available SAPIEN valve or the Evolut transcatheter aortic valve system.

SAPIEN valve is sold by Edwards Lifesciences Corporation (NYSE:EW), and Evolut is Medtronic Plc's NYSE: MDT) brand.

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 (the posterior probability for non-inferiority was 77.9%, which is lower than the non-inferiority test threshold of 97.5%).

"This trial is the largest randomized comparison of TAVR platforms and was conducted over four years, including during a global pandemic that introduced complexities for enrollment," said Michael Reardon, co-principal investigator of the ACURATE IDE trial.

The company also presented 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 reviewed key procedural factors, including pre-and post-dilation, which help 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. The assessment highlighted that approximately 20% of the valves were under-expanded.

Data from the assessment also demonstrated that the rate of 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.

The ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are approved in Europe.

In the U.S., the ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are investigational devices.

Price Action: BSX stock is down 1.66% at $83.16 at last check Wednesday.

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