Medtronic Announces CE Mark Approval and U.S. Clinical Milestone for Affera™ Sphere-360™ PFA Catheter

Medtronic has announced key regulatory and clinical milestones for its Affera™ Sphere-360™ pulsed field ablation (PFA) catheter, designed for the treatment of paroxysmal atrial fibrillation.

The Sphere-360 catheter has received CE Mark approval, allowing commercial use across Europe. 

In addition, the first patient cases have been completed in the United States as part of the Horizon 360 IDE pivotal clinical study.

Sphere-360 is an all-in-one mapping and single-shot PFA catheter that integrates navigation, mapping and ablation into a single device. 

When used with the Affera™ mapping and ablation system, the catheter is designed to simplify procedures and support consistent outcomes. 

Its adjustable 34 mm lattice structure conforms to different pulmonary vein anatomies, enabling circumferential lesion delivery without the need for catheter rotation.

The device allows treatment to be performed with a single transseptal puncture and no catheter exchange, helping to improve procedural efficiency. 

Additional features include real-time local impedance feedback, an over-the-wire design for enhanced stability, and compatibility with the FlexCath Contour™ 10 French deflectable sheath.

The Sphere-360 catheter is approved for clinical use in Europe and remains investigational in the United States, where evaluation is ongoing through the Horizon 360 IDE study.