secwatch / observer

8-K filed May 21, 2026, 4:31 PM ET ticker ADGM CIK 0002006986

regulatory confidence high sentiment positive materiality 0.65

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

Adagio Medical Holdings, Inc.

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.

item 8.01 item 9.01

Machine-readable event card

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
discovered_at: 2026-05-21T20:32:00.210973+00:00
generated_at: 2026-05-21T20:38:12.585728+00:00
sec_items: ["8.01", "9.01"]
event_type: regulatory
sentiment: positive
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: high
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