secwatch.observer — SEC 8-K summary
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Issuer:     Adagio Medical Holdings, Inc. (ADGM)
CIK:        0002006986
Form:       8-K
Filed at:   2026-04-27T23:59:59+00:00
Accession:  0001104659-26-048833
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Adagio Medical reports positive pivotal vCLAS ventricular ablation trial results
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- 84% freedom from ICD shock and 59% freedom from VT recurrence at 6 months in FULCRUM-VT study.
- 2.4% protocol-defined major adverse events; 98% non-inducibility of targeted VT at end of procedure.
- Equivalent outcomes for ischemic and non-ischemic cardiomyopathy patients from endocardial approach.
- 72% of patients discontinued or reduced amiodarone dose at 6 months; low 1.9% VT-related readmission rate.
- Results from 209-patient IDE trial to support FDA Premarket Approval application for vCLAS system.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2006986/000110465926048833/0001104659-26-048833-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2006986/000110465926048833/tm2612751d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-048833

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