---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-065180"
form_type: "8-K"
ticker: "ADGM"
cik: "0002006986"
company_name: "Adagio Medical Holdings, Inc."
filed_at: "2026-05-21T20:31:34+00:00"
generated_at: "2026-05-21T20:38:12.585728+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Adagio submits PMA to FDA for vCLAS VT ablation system; trial shows 97.4% acute success

## Summary
- PMA application for vCLAS Ventricular Ablation System to treat drug-refractory VT in structural heart disease.
- FULCRUM-VT pivotal trial (209 patients, 20 centers) achieved 97.4% acute clinical success and 84.3% freedom from ICD shock at 6 months.
- Major adverse events rate of 2.4%; 78% reduction or elimination of anti-arrhythmic drug use.
- First-ever PMA submission for a purpose-built VT ablation system; estimated addressable market of $5.8 billion.
- CEO Todd Usen states vCLAS endocardial-only approach could democratize VT ablation for electrophysiologists.

## SEC filing metadata
- accession: 0001104659-26-065180
- form_type: 8-K
- ticker: ADGM
- cik: 0002006986
- company_name: Adagio Medical Holdings, Inc.
- filed_at: 2026-05-21T20:31:34+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2006986/000110465926065180/0001104659-26-065180-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2006986/000110465926065180/tm2614299d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-065180
- JSON: https://secwatch.observer/filing/0001104659-26-065180.json
- Plain text: https://secwatch.observer/filing/0001104659-26-065180.txt

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