Medtronic(MDT) Prnewswire·2025-04-26 23:20Core Insights - Medtronic announced positive clinical outcomes from studies on atrial fibrillation (AFib) patients using the Affera™ technologies, including the Sphere-360™ and Sphere-9™ catheters [1][6] Group 1: Sphere-360 Study - The Sphere-360 catheter demonstrated an 88% freedom from arrhythmia recurrence and 98% durable pulmonary vein isolation (PVI) in a one-year study [2] - No safety events were reported in the subgroup treated with the optimized waveform, highlighting the safety profile of the Sphere-360 [2] - The Sphere-360 catheter features a conformable lattice design and is integrated with the Affera Mapping and Ablation System, utilizing the smallest sheath in single-shot PFA technology at 8.5 Fr [2][3] Group 2: Sphere-9 Catheter - The Sphere-9 catheter was shown to safely create linear lesions in persistent AF patients, enhancing the chances of restoring normal heart rhythm [4] - This catheter is part of the Affera system, which received FDA approval in October 2024, indicating its efficacy in persistent AF treatment [4] Group 3: Medtronic's Position and Future Plans - Medtronic plans to initiate a U.S. pivotal trial for the Sphere-360 catheter later in the year, indicating ongoing commitment to innovation in AFib treatment [3] - The company is the only one offering two PFA solutions, with the PulseSelect™ system already available in over 30 countries, showcasing its leadership in the electrophysiology market [5] - Medtronic continues to expand the Affera system's availability globally, with current access in Europe, Australia, and New Zealand [5]