secwatch.observer — SEC 8-K summary
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Issuer:     Adagio Medical Holdings, Inc. (ADGM)
CIK:        0002006986
Form:       8-K
Filed at:   2025-10-10T23:59:59+00:00
Accession:  0001104659-25-098701
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2006986/000110465925098701/0001104659-25-098701-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2006986/000110465925098701/tm2528457d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-098701

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