LivaNova's RECOVER depression trial enrollment expanded to 425 unipolar patients after interim analysis

LivaNova PLC

Independent Statistical Analysis Committee advised continuing enrollment to 425 unipolar patients, up from 400.
Interim analyses occur every 25 patients; cessation of RCT enrollment when predictive probability threshold met.
Final analysis after 12-month follow-up of last RCT patient; data to support CMS reimbursement reconsideration for VNS Therapy.
Company disclosed the update via Form 8-K on November 28, 2022, regarding event on November 23, 2022.

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