Affera™ momentum continues as Medtronic announces CE Mark in Europe and U.S. IDE first cases for Sphere-360™ PFA catheter to treat paroxysmal atrial fibrillation

By SquaredTown on January 23, 2026

Affera™ momentum continues as Medtronic announces CE Mark in Europe and U.S. IDE first cases for Sphere-360™ PFA catheter to treat paroxysmal atrial fibrillation

First-of-its-kind, rotation-free single-shot PFA catheter supported by strong safety and efficacy data adds to the groundbreaking Affera family of technologies in Europe Successful completion of first cases at multiple sites kicks off Horizon 360 IDE pivotal trial in the United States...

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