MDT · 10-Q · 2026Q3 · Full report
Sphere-9 Ventricular Ablation Expansion
Medtronic plc · 2026-09-03 · Importance 44 · Surprise 60 · In source text
Medtronic expanded the commercial opportunity for the Affera Mapping and Ablation System and Sphere-9 catheter through an expanded CE Mark indication in August 2026 for treatment of ventricular arrhythmias. The Sphere-360 pulsed field ablation single-shot catheter also received CE Mark in January 2026. The company expects continued acceptance and growth of the Affera system, Sphere-9, and Sphere-360 within its electrophysiology portfolio. These approvals broaden the addressable arrhythmia market beyond existing atrial fibrillation applications.
Key facts
- Medtronic expects continued acceptance, adoption, and growth of the PulseSelect pulsed field ablation system, the Affera mapping and ablation system with Sphere-9 catheter, and the Sphere-360 pulsed field ablation single-shot catheter; the Sphere-360 catheter received CE Mark in January 2026 and in August 2026 there was an expanded CE Mark indication for Affera and Sphere-9 for treatment of ventricular arrhythmias. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | Medtronic expects continued acceptance, adoption, and growth of the PulseSelect pulsed field ablation system, the Affera mapping and… |