Positive clinical trials for Medtronic’s Sphere-360™ Pulse Field Ablation (PFA) catheter

April 11, 2024- Medtronic plc announced positive clinical trial safety and efficacy results for Sphere-360™, an investigational single-shot mapping and ablation catheter using pulsed field (PF) energy, for treatment of patients with paroxysmal atrial fibrillation (AFib). Interim findings from the first-in-human Sphere-360 study were presented as a late-breaking clinical trial at the European Heart Rhythm Association (EHRA) 2024 Annual Meeting.

The Sphere-360 catheter was developed with the goal to simplify the atrial fibrillation procedure while enhancing efficiency and providing high durability of lesions. Its unique design includes a large, tissue-conformable lattice tip for efficient energy delivery, with no need to rotate the catheter multiple times in one location as the entire lattice tip delivers PF energy.

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