---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-095343"
form_type: "8-K"
ticker: "ADGM"
cik: "0002006986"
company_name: "Adagio Medical Holdings, Inc."
filed_at: "2025-10-01T23:59:59+00:00"
generated_at: "2026-05-17T05:09:11.768794+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Adagio completes enrollment in FULCRUM-VT pivotal IDE study for vCLAS cryoablation system

## Summary
- Enrolled 208 patients across 20 U.S. and Canadian centers for vCLAS System to treat monomorphic ventricular tachycardia.
- Study results support PMA application; FDA granted Breakthrough Device Designation for vCLAS.
- Primary efficacy endpoint: six-month freedom from recurrent MMVT without new/increased antiarrhythmic drugs.
- Company anticipates FDA PMA approval by year-end 2026, consistent with prior guidance.
- vCLAS System commercially available in Europe for MMVT; limited to investigational use in the U.S.

## SEC filing metadata
- accession: 0001104659-25-095343
- form_type: 8-K
- ticker: ADGM
- cik: 0002006986
- company_name: Adagio Medical Holdings, Inc.
- filed_at: 2025-10-01T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2006986/000110465925095343/0001104659-25-095343-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2006986/000110465925095343/tm2527681d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-095343
- JSON: https://secwatch.observer/filing/0001104659-25-095343.json
- Plain text: https://secwatch.observer/filing/0001104659-25-095343.txt

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