Boston Scientific announced encouraging 12-month results from the ADVANTAGE AF trial for its Farapulse pulsed field ablation (PFA) system. The study, which involved 255 patients, demonstrated significant effectiveness in treating persistent atrial fibrillation (AF) and atrial flutter (AFL), meeting all pre-specified safety and effectiveness endpoints.
Key findings include:
- 73.4% of patients achieved freedom from AF, AFL, and atrial tachycardia (AT), surpassing the 40% performance goal.
- 81% achieved freedom from symptomatic AFib recurrence.
- 96.4% of patients treated with the Farapoint catheter showed no AFL recurrence.
- Safety events were low, with a 2.4% rate and no major complications like pulmonary vein stenosis or phrenic nerve palsy.
The trial underscores the Farapulse system’s potential as a safe and effective therapy for persistent AF. Boston Scientific expects expanded FDA labeling and regulatory approvals in the coming months.
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