Boston Scientific's TAVR Pipeline Delayed; FDA Approval Of Acurate neo2 Set For 2024

The SCOPE II results could have helped support a PMA for Acurate neo2 in 2021, but the trial missed its primary endpoint, and the REPRISE IV trial of Boston Scientific's Lotus Edge TAVR system has been delayed by COVID-19.

Setback
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Boston Scientific Corporation is pushing back the expected approval timeline for its second-generation Acurate neo2 self-expanding transcatheter aortic valve by three years after two trials of the first-generation Acurate neo failed to meet their primary endpoints.

The company originally hoped the results of the SCOPE I and SCOPE II trials of the first generation...

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