Medtronic presents registry results for Sphere-9 and PulseSelect at APHRS 2026

Medtronic plc said on October 22, 2026 that real-world registry analyses of its Affera Mapping and Ablation System with the Sphere-9 Catheter and its PulseSelect Pulsed Field Ablation System showed positive results. The global analyses were presented at the Asia Pacific Heart Rhythm Society 2026 scientific meeting and evaluated prospectively enrolled patients with atrial fibrillation (AFib) and ventricular tachycardia (VT).

Medtronic said the APEX global registry analysis included 1,050 AFib patients treated with the Sphere-9 catheter and Affera system across 28 global sites. Medtronic said the major complication rate was 1.1%, with no acute kidney injury, severe coronary spasm or phrenic nerve injury. Medtronic also said major complication rates did not differ significantly between de novo and repeat ablation procedures.

Medtronic said the REAL PULSE global registry analysis of 1,160 AFib patients treated with the PulseSelect system across 38 global sites showed a 100% acute success rate and an acute major complication rate of 0.09%.

Medtronic said a separate European APEX registry analysis of 46 patients with ischemic and non-ischemic sustained VT showed acute success of 87% and estimated six-month freedom from VT recurrence of 75%. Medtronic said there was no significant difference in long-term freedom from arrhythmia recurrence between ischemic and non-ischemic cardiomyopathy patients. It also said six major complications were reported in four patients.

Sphere-9 is CE marked for VT but is investigational only and is not approved for VT in the United States. Medtronic said the ventricular ablation indication may not be approved or cleared in all markets.