secwatch.observer — SEC 8-K summary
======================================

Issuer:     LivaNova PLC (LIVN)
CIK:        0001639691
Form:       8-K
Filed at:   2022-10-11T23:59:59+00:00
Accession:  0001639691-22-000094
Event type: other_material
Sentiment:  neutral
Materiality: 0.55
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

LivaNova RECOVER depression trial enrollment continues from 375 to 400 unipolar patients
--------------------------------------------------------------------------------

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1639691/000163969122000094/0001639691-22-000094-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1639691/000163969122000094/livn-20221007.htm
  HTML page:      https://secwatch.observer/filing/0001639691-22-000094

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer