---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-048833"
form_type: "8-K"
ticker: "ADGM"
cik: "0002006986"
company_name: "Adagio Medical Holdings, Inc."
filed_at: "2026-04-27T23:59:59+00:00"
generated_at: "2026-05-15T04:05:17.797479+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Adagio Medical reports positive pivotal vCLAS ventricular ablation trial results

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-26-048833
- form_type: 8-K
- ticker: ADGM
- cik: 0002006986
- company_name: Adagio Medical Holdings, Inc.
- filed_at: 2026-04-27T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2006986/000110465926048833/0001104659-26-048833-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2006986/000110465926048833/tm2612751d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-048833
- JSON: https://secwatch.observer/filing/0001104659-26-048833.json
- Plain text: https://secwatch.observer/filing/0001104659-26-048833.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.