---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-040673"
form_type: "8-K"
ticker: "ADGM"
cik: "0002006986"
company_name: "Adagio Medical Holdings, Inc."
filed_at: "2026-04-08T23:59:59+00:00"
generated_at: "2026-05-15T06:56:39.475458+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Adagio Medical receives FDA IDE approval to study next-gen vCLAS ventricular ablation system

## Summary
- FDA grants IDE approval to expand FULCRUM-VT trial for next-gen vCLAS ULTA Ventricular Ablation System treating SMVT.
- System achieves ~ -170°C for single-freeze lesions with >50% reduction in ablation time vs prior models.
- Prospective, single-arm, multi-center sub-study of up to 55 patients for scar-mediated SMVT.
- Next-gen vCLAS Ultra catheter designed for improved maneuverability, shorter freeze times, and scalability.
- Goal is a single versatile catheter treating full VT range via endocardial approach on established ULTA platform.

## SEC filing metadata
- accession: 0001104659-26-040673
- form_type: 8-K
- ticker: ADGM
- cik: 0002006986
- company_name: Adagio Medical Holdings, Inc.
- filed_at: 2026-04-08T23:59:59+00:00
- event_type: regulatory
- 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/2006986/000110465926040673/0001104659-26-040673-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2006986/000110465926040673/tm2611362d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-040673
- JSON: https://secwatch.observer/filing/0001104659-26-040673.json
- Plain text: https://secwatch.observer/filing/0001104659-26-040673.txt

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