Adagio Medical Announces Positive Pivotal FULCRUM-VT Results; 84% Shock-Free at 6 Months
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Adagio Medical announced positive results from its FULCRUM-VT pivotal IDE trial, reporting 84% freedom from ICD shock and 59% freedom from VT recurrence at 6 months. Key highlights include 98% non-inducibility of targeted VTs post-procedure, a 2.4% major adverse event rate, and a 1.9% 30-day VT-related readmission rate, indicating a favorable safety profile. The outcomes were consistent across ischemic and non-ischemic cardiomyopathy patients, with over 72% of patients reducing or discontinuing amiodarone and an 80% reduction in ICD shocks post-ablation.
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