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Affera™ momentum continues as Medtronic announces CE Mark in Europe and U.S. IDE first cases for Sphere-360™ PFA catheter to treat paroxysmal atrial fibrillation
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced two major milestones for the Affera™ Sphere-360™ catheter, a first-of-its-kind, all-in-one mapping and single-shot pulsed field ablation (PFA) catheter for treatment of paroxysmal atrial fibrillation (AFib): CE Mark in Europe and the completion of first cases in the Horizon 360 IDE pivotal trial in the United States.
About this update from Medtronic Plc.
[{"type":"text","content":"First-of-its-kind, rotation-free single-shot PFA catheter supported by strong safety and efficacy data adds to the groundbreaking Affera family of technologies in Europe","length":169,"tagName":"p","attribs":{}},{"type":"text","content":"Successful completion of first cases at multiple sites kicks off Horizon 360 IDE pivotal trial in the United States","length":115,"tagName":"p","attribs":{}},{"type":"text","content":"GALWAY, Ireland, Jan. 23, 2026 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced two major milestones for the Affera™ Sphere-360™ catheter, a first-of-its-kind, all-in-one mapping and single-shot pulsed field ablation (PFA) catheter for treatment of paroxysmal atrial fibrillation (AFib): CE Mark in Europe and the completion of first cases in the Horizon 360 IDE pivotal trial in the United States.","length":454,"tagName":"p"},{"type":"text","content":"The Sphere-360 catheter was designed in response to physician feedback expressing the need for a simple, differentiated workflow and predictable outcomes using a single catheter that accommodates anatomical variations in pulmonary veins. Seamlessly integrated with the Affera mapping and ablation system, the catheter offers an adjustable configuration lattice design that conforms to the shape of the veins and allows energy delivery without the need to rotate the catheter in each position.","length":492,"tagName":"p"},{"type":"text","content":"The Affera mapping and ablation system and the Sphere-9™ all-in-one mapping and ablation catheter have been rapidly adopted by physicians in multiple geographies for their excellent safety and durability profile.","length":212,"tagName":"p"},{"type":"text","content":""The Sphere-360 catheter offers an excellent balance between ease of use and consistency in outcomes. Its design conforms to the pulmonary vein in a unique way that delivers consistent, effective and durable lesions for AFib patients, without any rotation of the catheter," said Tobias Reichlin, M.D., Director of Electrophysiology at Inselspital University Hospital in Bern, Switzerland. "With the full integration into the Affera mapping system, it's an exciting step forward for patient care in Europe."","length":530,"tagName":"p"},{"type":"text","content":"Additional benefits of Sphere-360 in...