October 22, 2026- Medtronic plc 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. The global registry analyses, presented at the Asia Pacific Heart Rhythm Society (APHRS) 2026 scientific meeting, evaluated prospectively enrolled patients with atrial fibrillation (AFib) and ventricular tachycardia (VT).
APEX registry: Sphere-9 real-world outcomes in atrial fibrillation
The APEX global prospective registry analysis included 1,050 patients with AFib treated with the Sphere-9 catheter and Affera Mapping and Ablation System across 28 global sites. The major complication rate was low at 1.1%, with no acute kidney injury, severe coronary spasm or phrenic nerve injury. Major complication rates did not differ significantly between de novo and repeat ablation procedures.
REAL PULSE global registry: PulseSelect real-world safety and performance
The REAL PULSE global prospective registry analysis included 1,160 atrial fibrillation patients treated with the PulseSelect PFA system across 38 global sites. Results were positive, including a 100% acute success rate and a low acute major complication rate of 0.09%.