MDT · News · 20260807N

Regulatory Approval Milestones

Medtronic plc · 2026-08-07 · Importance 38 · Surprise 60

Medtronic received an expanded CE Mark indication in Europe for the Affera Mapping and Ablation System with the Sphere-9 Catheter to treat ventricular arrhythmias, including ventricular tachycardia and premature ventricular complexes. The company stated that Sphere-9 is the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter CE marked for ventricular ablation. In the United States, the FDA has granted Sphere-9 Breakthrough Device Designation, and Medtronic is enrolling a pivotal Sphere VT trial to support a future U.S. approval.

Key facts

• Multiple reports state Medtronic received an expanded CE mark in Europe for the Affera mapping and ablation system and Sphere-9 catheter to treat ventricular arrhythmias, including ventricular tachycardia. source