May 20, 2024- Medtronic plc announced positive results demonstrating the safety and efficacy of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter. The product is apulsed field (PF) and radiofrequency (RF) ablation and high density (HD) mapping catheter for the treatment of persistent atrial fibrillation (AFib). The SPHERE Per-AF study, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) 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 (HRS) 2024 Annual Meeting and simultaneously published in Nature Medicine.