Boston Scientific Corporation (BSX) experienced a setback on Wednesday as the primary endpoint of the ACURATE IDE trial for its ACURATE neo2 Aortic Valve System failed to meet expectations. The trial, presented at the Transcatheter Cardiovascular Therapeutics 2024 symposium, compared the second-generation ACURATE neo2 valve against pre-defined control valves, specifically the SAPIEN valve (Edwards Lifesciences Corporation, EW) and the Evolut valve (Medtronic Plc, MDT).
The results revealed a composite rate of all-cause mortality, stroke, or rehospitalization at one year of 16.16% for the ACURATE neo2 arm, compared to 9.53% for the control arm. This outcome failed to achieve the pre-specified criterion for non-inferiority, with the posterior probability for non-inferiority falling below the threshold at 77.9%.
Despite the disappointing primary endpoint, Boston Scientific presented data from a post-hoc analysis that identified and evaluated expanded and under-expanded ACURATE neo2 valve frames within the trial. This analysis focused on procedural factors like pre-and post-dilation, which play a crucial role in ensuring proper valve expansion during the procedure. The assessment revealed that approximately 20% of the valves were under-expanded, but the rate of death, stroke, or rehospitalization at one year was similar between the expanded ACURATE neo2 group and the control group.
While the trial’s outcome may have dampened investor sentiment, Boston Scientific remains committed to the regulatory process. The company is actively working with the U.S. Food and Drug Administration (FDA) to obtain approval for the ACURATE valve platform in the United States. It’s worth noting that the ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are already approved in Europe.
The news of the trial’s results had an immediate impact on Boston Scientific’s stock price, which fell by 1.66% to $83.16 at the close of trading on Wednesday. Investors are closely watching the company’s progress in navigating the regulatory landscape and addressing the issues raised by the ACURATE IDE trial.
