MDT · News · 20260806N
Regulatory Approval Milestones
Medtronic plc · 2026-08-06 · Importance 38 · Surprise 60 · In source text
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
- The FDA has granted Breakthrough Device Designation for the Sphere-9 catheter for ventricular arrhythmias. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | contingent | — | The FDA has granted Breakthrough Device Designation for the Sphere-9 catheter for ventricular arrhythmias. |