Affera™ Momentum Continues as Medtronic Pronounces CE Mark in Europe and US IDE First Instances for Sphere-360™ PFA Catheter

Affera™ Momentum Continues as Medtronic Pronounces CE Mark in Europe and US IDE First Instances for Sphere-360™ PFA Catheter

January 23, 2026 – Medtronic introduced two main milestones for the Affera™ Sphere-360™ Catheter, an all-in-one mapping and single-shot pulsed subject ablation (PFA) catheter for the remedy of paroxysmal atrial fibrillation (AFib): CE Mark in Europe and the completion of the primary instances within the Horizon 360 IDE pivotal research in the US.

The Sphere-360 catheter was designed in response to suggestions from physicians who expressed the necessity for a easy, differentiated workflow and predictable outcomes utilizing a single catheter that accommodates anatomical variations in pulmonary veins. Seamlessly built-in with the Affera mapping and ablation system, the catheter provides an adaptable lattice design that conforms to the form of the veins and permits vitality supply with out the necessity to rotate the catheter to any place.

The Affera Mapping and Ablation System and the Sphere-9™ All-in-One Mapping and Ablation Catheter have been quickly adopted by physicians in a number of areas resulting from their wonderful security and sturdiness profiles.

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