newsfilter
← Latest News
Business Wire·

Adagio Medical Announces Positive Pivotal Results for vCLAS® Ventricular Ablation System

ADGM
  • Adagio Medical Holdings reported 6-month results from the FULCRUM-VT pivotal IDE trial for its vCLAS Ventricular Ablation System at the Heart Rhythm Society 2026 conference.
  • The trial met safety & effectiveness endpoints with 84% freedom from ICD shock & 59% freedom from VT recurrence at 6 months.
  • 98% of patients showed non-inducibility of targeted ventricular tachycardias at the end of the procedure.
  • Results demonstrated equivalent effectiveness for both ischemic cardiomyopathy (ICM) & non-ischemic cardiomyopathy (NICM) patients using an endocardial-only approach.
  • The study enrolled 209 patients across 20 centers in the U.S. & Canada, representing one of the most challenging cohorts in VT ablation trials.
  • Safety profile included a 2.4% rate of protocol-defined major adverse events, with only 1.0% of peri-procedural deaths adjudicated as possibly related to the device.
  • 72% of patients discontinued or reduced their amiodarone dosage at 6 months post-ablation.
  • There was an over 80% reduction in patients experiencing ICD shocks during the 6-month post-ablation period compared to the pre-ablation period.
  • The 30-day VT-related hospital readmission rate was 1.9%, significantly lower than historical VT ablation literature.
  • Mean ablation time was 54 minutes per patient with an average of 11.5 lesions created.
  • The trial results will support Adagio's application for FDA Premarket Approval to potentially secure the broadest industry indication for purely endocardial ablation of scar-mediated VT.
  • The vCLAS system is currently CE Marked & commercially available in Europe but remains under investigational use in the United States.