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Medtronic’s PulseSelect PFA System exceeds safety performance goal in trial
The Fly

Medtronic’s PulseSelect PFA System exceeds safety performance goal in trial

Medtronic announced that its PulseSelect Pulsed Field Ablation System exceeded its safety performance goal, with an adverse event rate of 0.7%, one of the lowest adverse event rates of any prior U.S. FDA Investigational Device Exemption trial for atrial fibrillation ablation or any multi-center PFA study. PULSED AF exceeded the threshold for its efficacy performance goal and further, clinical success, freedom from recurrence of any symptomatic atrial arrhythmias, was at least 80% for each patient cohort. Findings from the PULSED AF Pivotal Trial were presented as a late-breaking trial at the American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology and simultaneously published in Circulation.

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