MDT · News · 20260806N
Sphere-9 Ventricular Ablation Expansion
Medtronic plc · 2026-08-06 · Importance 38 · Surprise 60 · In source text
Medtronic received an expanded CE Mark indication for the Affera Mapping and Ablation System with the Sphere-9 Catheter to treat ventricular arrhythmias, including ventricular tachycardia and premature ventricular complexes. Sphere-9 is described as the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter CE marked for ventricular ablation, broadening its addressable use in Europe. The catheter also has FDA Breakthrough Device Designation, while the Sphere VT pivotal trial is enrolling patients to support a future U.S. approval.
Key facts
- Medtronic announced an expanded CE Mark indication for the Affera Mapping and Ablation System with Sphere-9 Catheter to treat ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVCs). source
- The Sphere VT U.S. pivotal trial enrollment is underway to support future U.S. approval for Sphere-9. source
- The Sphere-9 catheter is the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter CE marked for ventricular ablation. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | Medtronic announced an expanded CE Mark indication for the Affera Mapping and Ablation System with Sphere-9 Catheter to treat ventricular… |
| operating_income | negative | probable | — | The Sphere VT U.S. pivotal trial enrollment is underway to support future U.S. approval for Sphere-9. |
| revenue | positive | contingent | — | The Sphere VT U.S. pivotal trial enrollment is underway to support future U.S. approval for Sphere-9. |