Medtronic expands Sphere-9 CE Mark as pulsed-field ablation moves into ventricular arrhythmias
Medtronic has secured an expanded European CE Mark indication for its Affera Mapping and Ablation System with the Sphere-9 catheter, allowing the platform to treat ventricular arrhythmias including ventricular tachycardia and premature ventricular complexes. The August 6, 2026 regulatory expansion moves Sphere-9 beyond the atrial arrhythmias for which the system was initially commercialized. Medtronic describes
