Boston Scientific Corp (BSX)

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Boston Scientific's Acurate Neo valves lacked in comparison to Medtronic’s CoreValve

Oct. 15, 2020 Vandana Singh, SA News Editor

Boston Scientific fell (BSX -4.0%), after reporting that its Scope II trial showed Acurate Neo structural heart valves failed to demonstrate non-inferiority when compared to Medtronic’s CoreValve Evolut. Results were announced during the TCT 2020 Investor Update

Total 796 patients aged 75 years or older with symptomatic severe aortic stenosis and an indication for transfemoral TAVR were recruited.

The trial missed the primary endpoint of composite of all-cause mortality or all stroke at 1 year. The primary efficacy endpoint, powered for superiority, was new permanent pacemaker implantation at 30 days. Secondary endpoints included clinical efficacy and safety endpoints at 30 days and 12 months.

In the intention-to-treat analysis, death or stroke at one year was 15.8% in the Acurate neo group compared to 13.9% in the CoreValve Evolut group, for per-protocol analysis it was 15.3% vs. 14.3%.

Noninferiority of the Acurate neo was not met for the primary endpoint in the intent-to-treat analysis, while it was met in the per-protocol analysis.

Acurate Neo2 estimated approval and U.S. launch is 2024.