Medtronic Affera™ Mapping and Ablation System with Sphere-9™ Catheter achieves endpoints for safety and efficacy, providing promising evidence for the future of atrial fibrillation treatment

Core Insights - The SPHERE Per-AF trial shows that the Affera™ Mapping and Ablation System with Sphere-9™ Catheter provides excellent safety and efficacy for treating persistent atrial fibrillation (AFib) [1][2][4] Group 1: Study Results - Sphere-9 Catheter achieved a freedom from AFib rate of 73.8%, compared to 65.8% in the control group [3] - The primary safety endpoint rate for Sphere-9 was 1.4%, significantly lower than the control arm's 1.0%, with no reported safety events such as pulmonary vein stenosis or cardiac tamponade [2][3] - More than 95% of Sphere-9 procedures utilized a single transeptal puncture, compared to 62% in the control group [2] Group 2: Efficiency and Quality of Life - Sphere-9 demonstrated superior efficiency in procedural characteristics, including skin-to-skin procedural time and energy application time [3] - Patients treated with Sphere-9 reported improvements in both mental and physical quality of life [3] Group 3: Technology and Market Potential - The Sphere-9 Catheter features an all-in-one design with dual energy capabilities, integrating pulsed field and radiofrequency ablation [5][6] - The company has filed for FDA approval for the Sphere-9 Catheter in the U.S., with the device already receiving CE Mark approval in March 2023 [6][4] Group 4: Industry Context - AFib affects over 60 million people globally and is often undertreated, with persistent AFib patients making up 30-50% of the population [7] - The results from the SPHERE Per-AF trial are expected to significantly impact the treatment workflow in the electrophysiology community [6]