Medtronic has 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 2026 Asia Pacific Heart Rhythm Society (APHRS) annual meeting (21–24 October, Busan, South Korea)—evaluated prospectively enrolled patients with atrial fibrillation (AF) and ventricular tachycardia (VT).
“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,” said Khaldoun Tarakji, vice president and chief of science, research and technology, Electrophysiology Therapies, at Medtronic.
Shared at APHRS 2026, the APEX global prospective registry analysis included 1,050 patients with AF 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.
Additionally, regarding the REAL PULSE global prospective registry analysis—which included 1,160 AF 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%.
A separate European APEX registry analysis also evaluated use of the Sphere-9 catheter in patients undergoing ablation for VT, demonstrating promising results for the potential of the Sphere-9 catheter and PFA in a patient population that “can be challenging to treat”, as per a Medtronic press release.
This analysis included 46 patients with ischaemic and non-ischaemic sustained VT, and demonstrated high acute success (87%) and estimated six-month freedom from VT recurrence (75%). Furthermore, there was no significant difference in long-term freedom from arrhythmia recurrence in ischaemic and non-ischaemic cardiomyopathy patients. Six major complications were reported in four patients.
“As momentum continues to build across our portfolio, it is encouraging to see long-term data support the safety and efficacy profiles of our ablation technologies and the positive impact they are having on procedural workflows,” commented Felicia Kurz, vice president and general manager of cardiac ablation solutions, Electrophysiology Therapies, at Medtronic. “We will continue to innovate and strengthen our leadership in cardiac ablation, with a focus on advancing safe, effective and efficient care for patients.”
Medtronic notes that Sphere-9 is CE marked for VT, but is investigational only and not approved for VT in the USA, also stating that the ventricular ablation indication may not be approved or cleared in all markets.
