MDT · News · 20261022N

Sphere-9 Ventricular Ablation Expansion

Medtronic plc · 2026-10-22 · Importance 14 · Surprise 24

Medtronic reported positive real-world registry results for its Affera Mapping and Ablation System with the Sphere-9 Catheter and PulseSelect Pulsed Field Ablation System at APHRS 2026. The APEX analysis included 1,050 atrial-fibrillation patients and showed a 1.1% major complication rate, while the REAL PULSE registry of 1,160 patients reported 100% acute success and a 0.09% acute major complication rate. A European APEX analysis in ventricular-tachycardia patients showed 87% acute success and estimated 75% freedom from recurrence at six months. The data support Medtronic’s competitive positioning in cardiac ablation across atrial and ventricular arrhythmia procedures, alongside comparable pulsed-field-ablation launches from Johnson & Johnson.

Key facts

• Medtronic announced positive real-world registry results for the Affera Mapping and Ablation System with the Sphere-9 Catheter and the PulseSelect Pulsed Field Ablation (PFA) System presented at the Asia Pacific Heart Rhythm Society (APHRS) 2026 on Oct. 22, 2026. source
• The APEX analysis in 1,050 atrial fibrillation patients reported a 1.1% major complication rate. source
• The REAL PULSE registry reported 100% acute success and a 0.09% acute major complication rate in 1,160 atrial fibrillation patients. source
• Medtronic's PulseSelect system achieved 100% procedural success and a 0.09% major complication rate in a global registry. source