Medtronic Says Affera Sphere-360 Pulsed Field Ablation Catheter Received CE Mark in Europe

MT Newswires Live

01/23

Medtronic (MDT) said Friday it has received CE Mark approval in Europe for its Affera Sphere-360 catheter and has completed the first cases in the US Horizon 360 IDE pivotal trial.

Sphere-360 is an all-in-one mapping and single-shot pulsed field ablation catheter meant to treat paroxysmal atrial fibrillation, the company said.

Medtronic also said the CE mark approval was supported by European study results that showed "excellent efficacy, safety, and durability."

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