Medtronic plc announced that it has received CE Mark approval in Europe for the Affera™ Sphere-360™ catheter, an all-in-one mapping and single-shot pulsed field ablation (PFA) catheter for the treatment of paroxysmal atrial fibrillation. Additionally, the company has completed the first cases in the United States as part of the Horizon 360 IDE pivotal trial, which will evaluate the safety and effectiveness of the Sphere-360 catheter with the Affera mapping and ablation system.

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