Adagio Medical Holdings, Inc. - 8-K Filing
Adagio Medical submitted a Premarket Approval (PMA) application to the FDA for its vCLAS Ventricular Ablation System on May 21, 2026. The submission is supported by data from the FULCRUM-VT trial involving 209 patients across 20 centers, showing 97.4% acute clinical success and 84.3% freedom from ICD at six months. vCLAS targets a $5.8 billion market for treating ventricular tachycardia. (Items: 8.01 Other Events On May 21, 2026, Adagio Medical Holdings, Inc, 9.01 Financial Statements and Exhibits)
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