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.