Medtronic Affera Technologies Show Promising Results In Atrial Fibrillation Treatment

(RTTNews) - Medtronic plc (MDT) announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera family of technologies, including the next-generation Sphere-360 single-shot pulsed field ablation or PFA catheter and the groundbreaking Sphere-9 combination mapping and dual-energy focal PFA catheter.

The company noted that results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform.

Medtronic plans to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year.

Additionally, in a sub-analysis from the Sphere Per-AF IDE study, results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients.

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