---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-098701"
form_type: "8-K"
ticker: "ADGM"
cik: "0002006986"
company_name: "Adagio Medical Holdings, Inc."
filed_at: "2025-10-10T23:59:59+00:00"
generated_at: "2026-05-17T04:06:54.757296+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Adagio Medical reports 97.4% acute effectiveness in FULCRUM-VT pivotal study for VT ablation

## Summary
- 207 patients enrolled at 19 U.S./Canadian sites; 97.4% acute clinical success (non-inducibility of target VTs).
- Major adverse event rate 2.5%; four peri-procedural deaths (1.9%), one device-related (0.5%).
- Study included ICM and NICM patients (mean LVEF 35%, 75% with CHF); mean procedure time 206 min.
- ULTC system uses -196°C cryoablation without irrigation; 6-month primary endpoint expected at HRS 2026.
- Next-generation 8.5Fr catheter with shorter ablations in development.

## SEC filing metadata
- accession: 0001104659-25-098701
- form_type: 8-K
- ticker: ADGM
- cik: 0002006986
- company_name: Adagio Medical Holdings, Inc.
- filed_at: 2025-10-10T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2006986/000110465925098701/0001104659-25-098701-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2006986/000110465925098701/tm2528457d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-098701
- JSON: https://secwatch.observer/filing/0001104659-25-098701.json
- Plain text: https://secwatch.observer/filing/0001104659-25-098701.txt

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