Pulsed-Field Ablation System Approved by FDA for Patients With Paroxysmal Atrial Fibrillation
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April 25, 2024
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The FDA has approved Boston Scientific’s Farapulse system for treating refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
Farapulse is the second FDA-approved pulsed-field ablation system for this patient population, following Medtronic’s PulseSelect.
In the ADVENT trial, Farapulse was noninferior to thermal ablation in safety and efficacy after one year.
Farapulse showed shorter procedural duration but longer fluoroscopy duration compared to thermal ablation.
Real-world data indicated low major complication rates with Farapulse, with no cases of phrenic nerve palsy or esophageal injury.
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