Medtronic Received FDA Approval for Affera™ Mapping and Ablation System and Sphere-9™ Catheter, Pioneering Advances in Arrhythmia Treatment
On October 24, 2024, Medtronic plc, a global leader in healthcare technology, announced the United States Food and Drug Administration (FDA) approval of its Affera™ Mapping and Ablation System, paired with the Sphere-9™ Catheter. This innovative, high-density mapping and dual-technology catheter integrates pulsed field (PF) and radiofrequency (RF) ablation capabilities for the treatment of persistent atrial fibrillation (AFib) and cavotricuspid isthmus (CTI) dependent atrial flutter.
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