Galway, Ireland, October 22, 2026
Medtronic plc has announced positive real-world clinical registry results for its Sphere-9 catheter and PulseSelect Pulsed Field Ablation (PFA) System, highlighting safety and procedural outcomes in patients with abnormal heart rhythms. The findings from the global APEX and REAL PULSE registries were presented at the Asia Pacific Heart Rhythm Society (APHRS) 2026 scientific meeting. The analyses evaluated patients undergoing cardiac ablation for atrial fibrillation (AFib) and ventricular tachycardia (VT), two heart rhythm disorders that can require specialized treatment. The APEX registry assessed the Affera Mapping and Ablation System with the Sphere-9 catheter, while REAL PULSE evaluated the PulseSelect PFA System. According to Medtronic, the results add to the growing body of real-world evidence supporting its cardiac ablation technologies. The company says these systems are designed to help physicians treat arrhythmias while supporting procedural efficiency and patient safety. The findings provide additional information on how the technologies perform in clinical practice beyond controlled clinical trials, although registry results should be interpreted in the context of their patient populations, study design and follow-up periods.
Sphere-9 Registry Shows Safety Outcomes in Atrial Fibrillation
The global prospective APEX registry analysis included 1,050 patients with atrial fibrillation across 28 sites worldwide who were treated using the Sphere-9 catheter and Affera Mapping and Ablation System. The analysis reported a 1.1% major complication rate. Medtronic also reported no cases of acute kidney injury, severe coronary spasm or phrenic nerve injury in the analyzed population. These outcomes are relevant when evaluating cardiac ablation procedures, which aim to modify targeted heart tissue responsible for abnormal electrical signals. The registry further found no statistically significant difference in major complication rates between first-time and repeat ablation procedures. Sphere-9 combines high-definition cardiac mapping with pulsed field and radiofrequency ablation capabilities in a single catheter. Mapping helps physicians identify electrical activity in the heart, while ablation delivers energy to targeted tissue to interrupt pathways associated with arrhythmias. The integrated design is intended to support physicians performing complex procedures. However, registry findings do not establish that every patient will experience the same outcome, and procedural risks remain an important consideration in clinical decision-making. The APEX results add real-world evidence to the evaluation of the Sphere-9 technology in atrial fibrillation treatment.
PulseSelect Registry Reports 100% Acute Success
The REAL PULSE global prospective registry evaluated 1,160 patients with atrial fibrillation treated with the PulseSelect PFA System across 38 clinical sites. According to Medtronic, the analysis reported a 100% acute procedural success rate and an acute major complication rate of 0.09%. Acute success reflects the immediate procedural outcome defined by the registry and should not be interpreted as proof that arrhythmia will never recur. PulseSelect uses pulsed field ablation, a technique that delivers electrical pulses to target cardiac tissue involved in abnormal rhythm generation. PFA differs from conventional thermal ablation approaches because it uses electrical energy rather than relying primarily on heat or cold to destroy targeted cells. The PulseSelect system is designed as a single-shot solution for pulmonary vein isolation, a procedure commonly used to treat atrial fibrillation by electrically separating the pulmonary veins from the left atrium. The registry findings provide additional evidence on procedural performance and acute safety in routine clinical settings. Longer-term follow-up and the wider evidence base remain important for assessing sustained effectiveness, recurrence rates and outcomes across different patient groups.
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Sphere-9 Ventricular Tachycardia Data Add Evidence
A separate European APEX registry analysis examined Sphere-9 use in 46 patients with sustained ventricular tachycardia, including patients with ischemic and non-ischemic heart disease. The analysis reported 87% acute procedural success and an estimated 75% freedom from ventricular tachycardia recurrence at six months. Six major complications were reported in four patients, an important safety detail when interpreting these results. Ventricular tachycardia can be a serious condition, particularly in patients with underlying structural heart disease, and its treatment may involve complex ablation procedures. Medtronic stated that long-term freedom from arrhythmia recurrence did not differ significantly between patients with ischemic and non-ischemic cardiomyopathy in this analysis. Sphere-9 is CE marked for ventricular tachycardia treatment in applicable markets but remains investigational and is not approved for this indication in the United States. The findings are therefore encouraging but preliminary, given the small patient population. Overall, the APEX and REAL PULSE registry results expand the real-world evidence available for Medtronic’s cardiac ablation portfolio and may help inform further clinical evaluation of technologies for treating atrial and ventricular arrhythmias.
Source: Medtronic press release
