Medtronic Reports (PULSED AF) Trial Results of PulseSelect PFA System for Atrial Fibrillation

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The (PULSED AF) pivotal trial evaluating PulseSelect System in 300 adult patients with a history of drug refractory, recurrent & symptomatic paroxysmal or persistent AF at 9 countries across 41 sites & 67 operators
The system showed a low rate of primary safety AEs (0.7%) with no esophageal events, instances of pulmonary vein stenosis, or phrenic nerve injury
Pulsed-field ablation was shown to be effective @1yr. in 66.2% with paroxysmal AF & 55.1% with persistent AF @12mos., freedom from atrial arrhythmia recurrence & symptomatic atrial arrhythmias was 70% & 80% in the paroxysmal; 62% & 81% in the persistent cohort. The results were presented at ACC.23/WCC & simultaneously published in Circulation

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