secwatch.observer — SEC 8-K summary
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Issuer:     Adagio Medical Holdings, Inc. (ADGM)
CIK:        0002006986
Form:       8-K
Filed at:   2026-05-21T20:31:34+00:00
Accession:  0001104659-26-065180
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2006986/000110465926065180/0001104659-26-065180-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2006986/000110465926065180/tm2614299d2_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-065180

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer