Medtronic announced two milestones for the Affera Sphere-360 catheter, an all-in-one mapping and single-shot pulsed field ablation (PFA) catheter for treatment of paroxysmal atrial fibrillation (AFib): CE Mark in Europe and the completion of first cases in the Horizon 360 IDE pivotal trial in the United States.
Integrated with the Affera mapping and ablation system, the catheter offers an adjustable configuration lattice design that conforms to the shape of the veins and allows energy delivery without the need to rotate the catheter in each position.
Additional benefits of Sphere-360 include:
- Delivers circumferential, consistent lesions from the entire 34 mm lattice without catheter rotation, enhancing workflow efficiency
- Adapts to the vein by adjusting the shape of the conformable lattice to the patient's anatomy
- All-in-one catheter for navigation, mapping, and ablation with a single transseptal puncture and zero catheter exchange
- Real-time local impedance information to assess catheter proximity to tissue
- Easy access to pulmonary veins with enhanced stability through its over-the-wire design
- Compatible with FlexCath Contour™ 10 French deflectable sheath designed for easy catheter positioning
The Horizon 360 IDE study is a prospective, single-arm clinical study at centers across the U.S. The study will evaluate the safety and effectiveness of the Sphere-360 catheter with the Affera mapping and ablation system for treating paroxysmal AFib.
