secwatch.observer — SEC 8-K summary
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Issuer:     LivaNova PLC (LIVN)
CIK:        0001639691
Form:       8-K
Filed at:   2023-02-17T23:59:59+00:00
Accession:  0001639691-23-000006
Event type: other_material
Sentiment:  neutral
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

LivaNova: RECOVER depression trial enrollment extended to 475 unipolar patients
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1639691/000163969123000006/0001639691-23-000006-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1639691/000163969123000006/livn-20230217.htm
  HTML page:      https://secwatch.observer/filing/0001639691-23-000006

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