Adagio Medical reports positive pivotal vCLAS ventricular ablation trial results

Adagio Medical Holdings, Inc.

84% freedom from ICD shock and 59% freedom from VT recurrence at 6 months in FULCRUM-VT study.
2.4% protocol-defined major adverse events; 98% non-inducibility of targeted VT at end of procedure.
Equivalent outcomes for ischemic and non-ischemic cardiomyopathy patients from endocardial approach.
72% of patients discontinued or reduced amiodarone dose at 6 months; low 1.9% VT-related readmission rate.
Results from 209-patient IDE trial to support FDA Premarket Approval application for vCLAS system.

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