Medtronic (NYSE: MDT) announced positive clinical outcomes from two studies using their Affera™ family of technologies for atrial fibrillation treatment. The Sphere-360™ single-shot PFA catheter demonstrated 88% freedom from arrhythmia recurrence and 98% pulmonary vein isolation at one year, with no reported safety events in the optimized waveform group.
The Sphere-9™ catheter showed effectiveness for linear ablation in persistent AFib patients, based on sub-analysis from the Sphere Per-AF IDE study. The device received FDA approval in October 2024. Medtronic plans to begin U.S. pivotal trials for Sphere-360 later this year.
The company currently offers two PFA solutions: the PulseSelect™ system available in over 30 countries, and the Affera system with Sphere-9 catheter available in Europe, Australia, and New Zealand. AFib affects more than 60 million people worldwide and is a progressive disease that increases risks of heart failure, stroke, and death.
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