Medtronic announced positive results demonstrating excellent safety and efficacy of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one pulsed field and radiofrequency ablation and high density mapping catheter for the treatment of persistent atrial fibrillation. The SPHERE Per-AF study, a U.S. FDA Investigational Device Exemption pivotal trial, compared Sphere-9 to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 System. Findings were presented as late-breaking clinical data at the Heart Rhythm Society 2024 Annual Meeting and simultaneously published in Nature Medicine.
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