Medtronic’s Sphere-9 catheter and Affera mapping and ablation system has secured a CE mark in Europe for ventricular arrhythmia treatment.
The integrated mapping and ablation catheter obtained its initial CE mark in March 2023 for treating atrial arrhythmias such as atrial fibrillation and cavotricuspid isthmus (CTI)–dependent atrial flutter. The system gained US Food and Drug Administration (FDA) clearance for treating the same conditions in October 2024.
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With the CE mark indication expansion in hand, Sphere-9 and Affera is now the first all-in-one mapping and ablation, dual-energy catheter CE marked for ventricular ablation, Medtronic stated.
Commenting on the CE mark expansion, Rebecca Seidel, president of Medtronic’s electrophysiology therapies business, said: “This milestone is a major step forward as we continue to expand the footprint of the Affera technology to more physicians and patients.
“Indication expansion to include ventricular arrhythmias unlocks another fast-growing market opportunity to keep building on our momentum, powered by the versatility, safety and efficiency of the Sphere-9 catheter.”
Medtronic is also seeking US clearance for Sphere-9 and Affera in ventricular arrhythmia treatment and is currently generating safety and efficacy data in its Sphere VT (NCT07585968) investigational device exemption trial to support a filing with the FDA.
The medtech giant received breakthrough device designation for Sphere-9 and Affera in treating ventricular arrhythmias in April 2026.
The clearance means Medtronic’s device has gained access to more patients with heart rhythm conditions. Ventricular arrhythmias such as ventricular tachycardia (VT) are a potentially life-threatening condition that cause the heart to beat abnormally fast. Unlike atrial fibrillation, VT affects the lower chamber of the heart and often presents after a heart attack or alongside other advanced heart diseases.
Medtronic shared results from the ongoing early feasibility study evaluating Sphere-9 and Affera in the treatment of recurrent sustained monomorphic VT after a heart attack at the Heart Rhythm Society (HRS) Annual Meeting in April. Patients treated at centres across the US were followed for six months post-ablation with 65.5% remaining free from VT recurrence at six months.
“Physicians have long needed better tools for ventricular arrhythmias, and we’re proud to deliver a technology that addresses this unmet need and moves the needle on patient care,” said Khaldoun Tarakji, vice president and CMO of Medtronic’s cardiac ablation solutions business.
Unlike Medtronic’s PulseSelect, which is a fixed 9-electrode single-shot catheter, Sphere-9 is an all-in-one, dual-energy option, comprising of pulsed field and radiofrequency ablation. The main rival to Medtronic’s two systems is Boston Scientific’s Farapulse, though this is not yet approved for ventricular arrhythmia.
