Medtronic Reports Positive Results for New Affera Pulsed Field Ablation Technologies in AFib Treatment

Medtronic announced promising one-year clinical trial results for its next-generation Sphere-360 pulsed field ablation (PFA) catheter and Sphere-9 dual-energy catheter at the Heart Rhythm Society 2025 Annual Meeting. The Sphere-360 catheter showed an 88% freedom from arrhythmia recurrence rate and a 98% chronic pulmonary vein isolation success rate, with no serious adverse events reported.

Additionally, a sub-analysis of the Sphere Per-AF IDE study demonstrated that the Sphere-9 catheter safely and effectively enables linear ablation in persistent AFib patients. Medtronic plans to begin a U.S. pivotal trial for Sphere-360 later this year. The company continues to expand its electrophysiology leadership with its Affera and PulseSelect PFA systems, aiming to provide more treatment options for atrial fibrillation, which affects over 60 million people worldwide.