Medtronic reports ‘positive’ trial, safety results from study of Sphere-360

Medtronic announced positive clinical trial safety and efficacy results for Sphere-360, an investigational single-shot mapping and ablation catheter using pulsed field energy, for treatment of patients with paroxysmal atrial fibrillation. Interim findings from the first-in-human Sphere-360 study were presented as a late-breaking clinical trial at the European Heart Rhythm Association 2024 Annual Meeting. The Sphere-360 study, a prospective, single arm, multi-center trial performed in three European centers with a total of 85 patients, demonstrated 81.8% freedom from atrial arrhythmias after one year of follow up, and 100% freedom in the sub-group treated with the optimized and most recent pulse configuration. The treatment time, or first to last PF application, was 10 minutes on average. A sub-study of patients treated with the optimized pulse underwent remapping procedures; 96% of those patients demonstrated sustained lesion durability, and among all the pulmonary veins treated in this group, 99% remained isolated after 75 days of the index procedure. The study also showed the catheter to have a highly favorable safety profile, with zero incidences of primary safety adverse events including esophageal events, pulmonary vein stenosis, phrenic nerve injury or cardiac tamponade.