other material
confidence high
sentiment neutral
materiality 0.55
LivaNova RECOVER depression trial enrollment continues from 375 to 400 unipolar patients
LivaNova PLC
- Independent Statistical Analysis Committee advised continuation of RECOVER trial enrollment from 375 to 400 unipolar patients, per protocol.
- Trial includes frequent interim analyses every 25 patients to assess predictive probability of success.
- Upon meeting success criteria, RCT enrollment stops and patients enter open-label longitudinal study.
- Final analysis after last RCT patient completes 12 months follow-up; data to support peer-reviewed article.
- Success could lead to CMS reconsideration of reimbursement for VNS Therapy for difficult-to-treat depression.