Medtronic Says PulseSelect Ablation System Demonstrates 'Impressive Results'

Medtronic plc MDT announced that its PulseSelect Pulsed Field Ablation (PFA) System exceeded its safety performance goal, with an adverse event rate of 0.7%, one of the lowest adverse event rates of any prior FDA Investigational Device Exemption (IDE) trial for atrial fibrillation (AF) 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.
PFA is an ablation technology that uses pulsed electric fields to isolate the pulmonary veins for patients with paroxysmal or persistent AF.
There were no esophageal events, pulmonary vein stenosis, or phrenic nerve injury.
PULSED AF exceeded the threshold for efficacy performance at 66% efficacy in paroxysmal AF patients and 55% in persistent AF patients, based on the pre-specified performance goals of >50% (paroxysmal) and >40% (persistent) at 12 months.
Freedom from atrial arrhythmia recurrence at 12 months was 70% in the paroxysmal cohort and 62% in the persistent. Additionally, clinical success, freedom from recurrence of any symptomatic atrial arrhythmias, was 80% for paroxysmal and 81% for the persistent cohort.
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