Medtronic gains FDA approval for its Affera™ Mapping and Ablation System with the Sphere-9™ Catheter, marking a breakthrough in electrophysiology
Medtronic plc a global leader in healthcare technology, announced United States Food and Drug Administration (FDA) approval of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter, an all-in-one, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter for treatment of persistent atrial fibrillation (AFib) and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.