Medtronic has announced two key milestones for its Affera Sphere-360 pulsed field ablation catheter for treating paroxysmal atrial fibrillation. The device has received CE Mark approval in Europe and has completed first patient cases in the Horizon 360 IDE pivotal trial in the United States.
Sphere-360 is a rotation free single shot PFA catheter designed to combine mapping and ablation in one device. It integrates with the Affera mapping and ablation system and features an adjustable lattice design that conforms to pulmonary vein anatomy. This allows energy delivery without rotating the catheter which is intended to simplify workflows and support predictable outcomes.
The catheter was developed based on physician feedback calling for simpler procedures and consistent results across varying anatomies. It enables navigation mapping and ablation with a single transseptal puncture and no catheter exchange. Additional features include real time local impedance data enhanced stability through an over the wire design and compatibility with Medtronic sheaths.
Completion of the first U.S. cases marks the start of the Horizon 360 IDE pivotal trial and builds on adoption of the Affera platform in multiple regions following positive safety and durability data.
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