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Adagio Medical Unveils Preliminary Acute Results from FULCRUM-VT U.S. Pivotal Study in Late Breaking Session at VT Symposium
Businesswire· 2025-10-10 19:40
Core Insights - Adagio Medical Holdings, Inc. announced preliminary results from the FULCRUM-VT Study, demonstrating 97.4% acute clinical success in treating Sustained Monomorphic Ventricular Tachycardia (SMVT) using their proprietary Ultra-Low Temperature Cryoablation (ULTC) technology [1][2][5] Study Overview - The FULCRUM-VT Study involved 207 patients across 19 sites in the U.S. and Canada, focusing on both ischemic and non-ischemic cardiomyopathy [2][8] - The study reported a mean procedure duration of 206 minutes and a 2.5% rate of major adverse events, including four peri-procedural deaths [2][4] Efficacy and Safety Results - Acute clinical success was defined as the non-inducibility of target ventricular arrhythmias, achieved in 97.4% of cases, with 96.7% of patients having all clinically relevant ventricular tachycardias eliminated [2][4] - The safety profile of the ULTC system was deemed favorable, with a low rate of major adverse events [4][5] Future Outlook - The company plans to present six-month primary efficacy endpoint results at the Heart Rhythm 2026 conference, indicating ongoing commitment to research and development [4][5] - The FULCRUM-VT Study aims to support FDA premarket approval for the vCLAS™ Cryoablation System, potentially leading to broader indications for treating scar-mediated VT [8][9]