other material
confidence high
sentiment neutral
materiality 0.50
LivaNova: RECOVER depression trial enrollment extended to 475 unipolar patients
LivaNova PLC
- Independent Statistical Analysis Committee advises to continue enrollment from 450 to 475 unipolar patients.
- Trial uses interim analyses every 25 patients; predictive probability of success not yet reached.
- Successful trial could support reconsideration of CMS reimbursement for VNS Therapy for difficult-to-treat depression.
- After last RCT patient completes 12-month follow-up, final analysis will be conducted on complete dataset.