Medtronic(US:MDT) Prnewswire·2026-01-23 12:02Core Insights - Medtronic announced the CE Mark approval for the Sphere-360 catheter and the initiation of the Horizon 360 IDE pivotal trial in the U.S. for treating paroxysmal atrial fibrillation (AFib) [1][6] Product Overview - The Sphere-360 catheter is a first-of-its-kind, all-in-one mapping and single-shot pulsed field ablation (PFA) catheter designed to treat paroxysmal AFib, featuring a unique design that eliminates the need for catheter rotation [1][2] - It integrates seamlessly with the Affera mapping and ablation system, providing an adjustable configuration that conforms to the anatomy of pulmonary veins [2][4] Clinical Adoption and Efficacy - The Sphere-360 catheter has been rapidly adopted by physicians due to its excellent safety and durability profile, with positive outcomes reported in a European study presented at the Heart Rhythm Society Annual Meeting [3][5] - The one-year results from the European study demonstrated excellent efficacy, safety, and durability, contributing to the CE Mark approval [5] Technological Advancements - The Sphere-360 catheter delivers circumferential, consistent lesions from a 34 mm lattice without catheter rotation, enhancing workflow efficiency [6] - It adapts to the patient's anatomy through a conformable lattice design, allowing for effective energy delivery [6] Market Position and Future Outlook - Medtronic is committed to leading in PFA technology and aims to deliver innovative treatments for AFib patients regularly [6] - The company has established itself as a pioneer in PFA offerings, with the PulseSelect PFA System already available in over 35 countries [8]