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Medtronic announces CE Mark and first US trial for Affera Sphere-360 catheter.
ByAinvest
Friday, Jan 23, 2026 7:06 am ET1min read
MDT--
Medtronic has announced the CE Mark in Europe and completion of first cases in the Horizon 360 IDE pivotal trial in the US for the Affera Sphere-360 catheter. This is a first-of-its-kind, all-in-one mapping and single-shot PFA catheter for treating paroxysmal atrial fibrillation. The catheter is designed to simplify the workflow and provide predictable outcomes using a single device.
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