{"schema_version":"secwatch.filing_event.v1","accession":"0001639691-22-000094","form_type":"8-K","ticker":"LIVN","cik":"0001639691","company_name":"LivaNova PLC","filed_at":"2022-10-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.529332+00:00","generated_at":"2026-06-23T04:25:29.497577+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"LivaNova RECOVER depression trial enrollment continues from 375 to 400 unipolar patients","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001639691-22-000094","json":"https://secwatch.observer/filing/0001639691-22-000094.json","markdown":"https://secwatch.observer/filing/0001639691-22-000094.md","text":"https://secwatch.observer/filing/0001639691-22-000094.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1639691/000163969122000094/0001639691-22-000094-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1639691/000163969122000094/livn-20221007.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T04:25:29.497577+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}