Medtronic announces positive results from real-world registries for the Sphere-9™ catheter and PulseSelect™ PFA System at APHRS 2026
Key Highlights
- ➤PulseSelect registry: 100% acute success and 0.09% acute major complication rate
- ➤Sphere-9 AFib registry: 1.1% major complication rate across 1,050 patients
- ➤Sphere-9 VT analysis: 87% acute success and 75% six-month freedom from recurrence
- ➤APEX VT analysis reported six major complications in four patients
- ➤Sphere-9 is investigational and not approved for VT in the United States
Expert Statements
Khaldoun Tarakji, Vice President and Chief of Science, Research and Technology, Electrophysiology Therapies at Medtronic
“These favorable 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.”
Felicia Kurz, Vice President and General Manager, Cardiac Ablation Solutions, part of the Electrophysiology Therapies business at Medtronic
“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.”
Felicia Kurz, Vice President and General Manager, Cardiac Ablation Solutions, part of the Electrophysiology Therapies business 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 announces positive results from real-world registries for the Sphere-9™ catheter and PulseSelect™ PFA System at APHRS 2026 PR Newswire
* Global APEX and REAL PULSE Registry analyses report strong safety and procedural outcomes across atrial and ventricular arrhythmias * Medtronic continues to strengthen its position in cardiac ablation, building on a legacy of innovation in electrophysiology GALWAY, Ireland, Oct. 22, 2026 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today 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).
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