Medtronic's Sphere-360™ Pulse Field Ablation Catheter: Transforming Treatment for Paroxysmal Atrial Fibrillation

Monday, April 08, 2024

Medtronic plc, a renowned healthcare technology leader, has unveiled promising results from clinical trials for Sphere-360™. This innovative catheter employs pulsed field (PF) energy for mapping and ablation in patients with paroxysmal atrial fibrillation (AFib). Presented at the European Heart Rhythm Association (EHRA) 2024 Annual Meeting, interim findings from the first-in-human Sphere-360 study showcased its safety and efficacy.

Designed to simplify AFib procedures while ensuring efficiency and durability of lesions, the Sphere-360 catheter features a unique large lattice tip for optimal energy delivery without the need for multiple rotations. Fully integrated with the Affera™ Mapping and Ablation System, it offers comprehensive visualization and mapping capabilities, making it a versatile all-in-one solution.

The Sphere-360 study, conducted across three European centers with 85 patients, demonstrated promising outcomes. After one year of follow-up, 81.8% of patients were free from atrial arrhythmias, with a 100% freedom rate in a subgroup treated with the latest pulse configuration. Treatment time averaged 10 minutes, and a sub-study revealed excellent lesion durability and pulmonary vein isolation rates.

The catheter boasts a favorable safety profile, with no primary safety adverse events reported. Features include uniform PF energy delivery, real-time local impedance information, and compatibility with the Affera system for low to zero fluoroscopy procedures.

Atrial fibrillation is a prevalent yet undertreated heart rhythm disorder, affecting millions worldwide and carrying serious complications. Despite the current standard of antiarrhythmic drug therapy, which is ineffective in many patients, Sphere-360 offers a promising alternative for improved outcomes in AFib management.


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