secwatch.observer — SEC 8-K summary
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Issuer:     LivaNova PLC (LIVN)
CIK:        0001639691
Form:       8-K
Filed at:   2022-11-28T23:59:59+00:00
Accession:  0001639691-22-000110
Event type: other_material
Sentiment:  neutral
Materiality: 0.55
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1639691/000163969122000110/0001639691-22-000110-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1639691/000163969122000110/livn-20221123.htm
  HTML page:      https://secwatch.observer/filing/0001639691-22-000110

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