Medtronic has reported positive real-world registry findings for its cardiac ablation technologies in patients treated for atrial fibrillation (AFib) and ventricular tachycardia (VT).
The clinical analyses evaluated prospective patient outcomes for the Affera mapping and ablation system with the Sphere-9 Catheter and the PulseSelect pulsed field ablation (PFA) system.
These findings were presented at the Asia Pacific Heart Rhythm Society (APHRS) 2026 scientific meeting.
In the REAL PULSE prospective study, clinicians evaluated 1,160 AFib patients across 38 international centres using the PulseSelect PFA system.
The analysis recorded a 100% success rate and an acute major complication rate of 0.09%.
Concurrently, the global APEX prospective registry assessed 1,050 AFib patients treated at 28 sites with the Affera mapping and ablation system and the Sphere-9 catheter.
Investigators recorded a 1.1% major complication rate, with no cases of severe coronary spasm, acute kidney injury, or phrenic nerve injury.
The frequency of major complications showed no significant variance between initial ablation procedures and repeat interventions.
Medtronic vice-president and science, research and technology, electrophysiology therapies chief Khaldoun Tarakji said: “These favourable results reinforce our confidence in the safety and performance of our ablation technologies worldwide.
“It is very encouraging to see physicians’ positive response and real-world evidence that supports effective, safe, and efficient care for patients with a wide range of arrhythmias.”
A separate European cohort from the APEX registry evaluated 46 individuals undergoing catheter ablation for sustained ischaemic and non-ischaemic VT using the Sphere-9 catheter.
The analysis showed an acute success rate of 87% and an estimated six-month freedom from arrhythmia recurrence of 75%.
Long-term freedom from recurrent VT did not differ significantly between patients with ischaemic cardiomyopathy and those with non-ischaemic cardiomyopathy. Across the cohort, four patients experienced a total of six major complications.
The Medtronic electrophysiology portfolio includes the Affera mapping and ablation system, the PulseSelect PFA system, and the Sphere-9 catheter.
PulseSelect provides a single-shot mechanism for pulmonary vein isolation, whereas Sphere-9 operates with the Affera platform to combine high-definition mapping with radiofrequency and pulsed field energy.
