Medtronic reports positive results from Affera Mapping and Ablation System with Sphere-9 Catheter to treat persistent AFib

Medtronic plc, a global healthcare technology leader, announced promising results from the SPHERE Per-AF study, evaluating the Affera Mapping and Ablation System with Sphere-9 Catheter for persistent atrial fibrillation (AFib). The study, an FDA Investigational Device Exemption pivotal trial, compared Sphere-9 to standard radiofrequency ablation catheters. Results, presented at the Heart Rhythm Society 2024 Annual Meeting and published in Nature Medicine, showed Sphere-9's superior safety and efficacy.

Sphere-9 demonstrated a low primary safety endpoint rate of 1.4%, with no major safety issues reported. Over 95% of Sphere-9 procedures required a single transeptal puncture versus 62% in the control arm.

Patients treated with Sphere-9 experienced a 73.8% freedom from AFib, with fewer arrhythmia recurrences post-treatment. The study also highlighted Sphere-9's procedural efficiency, with shorter procedural times and energy application durations.

The trial enrolled 420 patients across 23 sites in the United States, Czech Republic, and Israel, all undergoing pulmonary vein isolation and linear lesion procedures. AFib affects over 60 million people globally, making it a widespread and undertreated heart rhythm disorder.