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The expanded instructions for use labeling expand on the Farawave and Farawave Nav Pulsed Field Ablation (PFA) catheters.
The FDA approved a label extension for the Farapulse Pulsed Field Ablation (PFA) system (Boston Scientific) to now include approval for the system in the treatment of drug-refractory, symptomatic persistent atrial fibrillation (AF). This approval specifically updates the instructions for use for both the Farawave PFA catheter and the Farawave Nav PFA catheter to include treatment for patients with persistent AF, according to the manufacturer.1
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Trial Name: A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation (ADVANTAGE AF)
ClinicalTrials.gov ID: NCT05443594
Sponsor: Boston Scientific Corporation
Completion Date (Estimated): March 2025
AF affects approximately 59 million people worldwide, according to a news release, and many have the persistent form of the condition, which can cause dizziness, fatigue, shortness of breath, and increased risk of stroke. During episodes, the heart’s upper chambers beat chaotically and irregularly, working out of sync with the lower heart chambers. AF itself is not believed to be life-threatening; however, it remains a serious health condition that needs proper treatment and regulation to prevent the risk of stroke. Treatments can involve catheters, medications (eg, beta blockers, calcium channel blockers, and blood thinners), surgery, and cardioversion therapy.1,2
Both the Farawave and Farawave Nav PFA catheters are indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic paroxysmal AF and the isolation of pulmonary veins and the posterior wall in the treatment of drug-persistent AF (episode durations < 1 year). Both systems are intended for adults aged 18 years and older with cardiac arrhythmia.3
The FDA approval for the expanded labeling was supported by clinical data from phase 1 of the ADVANTAGE AF clinical trial (NCT05443594)4, which were presented at the 2025 Atrial Fibrillation Symposium and published in the Journal of the American College of Cardiology.5 For this trial, the investigators assessed the safety and efficacy of pulmonary vein isolation (PVI) and posterior wall ablation (PWA) with pulsed field ablation (PFA) in persistent AF.1
A total of 339 patients (treatment: n = 260; roll-in: n = 79) with persistent AF were enrolled in the prospective, single-arm, multicenter trial. All patients in the phase 1 portion received intervention with a Farapulse Ablation System to isolate the pulmonary veins and posterior wall. The primary safety end point was incidence of predefined adverse events (AEs), and the primary efficacy end points were acute success and postblanking 1-year freedom from atrial tachyarrhythmia recurrence (> 30 seconds), redo ablation, cardioversion, or antiarrhythmic drug escalation. One-year follow-up included 24-hour Holter monitoring at 6 and 12 months and twice-monthly and symptomatic transtelephonic monitoring.4,5
The findings demonstrated there was an approximate 99.7% success for both PVI and PWA in patients with persistent AF. The primary safety end point was approximately 2.3% (5.1% upper confidence limit), including 1 patient with pericarditis, 1 with myocardial infarction, and 4 with pulmonary edema. There were no instances of tamponade, stroke, pulmonary vein stenosis, or esophageal fistula that were observed, according to the investigators.5
Further, primary effectiveness was approximately 63.5% (57.3% lower confidence limit) at the 1-year point, with about 8.5% of patients having a single isolated AF recurrence. Freedom from symptomatic AF was approximately 85.3%, although the investigators acknowledged that efficacy varied by operator experience.5
"Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AF treatment with safe and effective ablation technologies," Brad Sutton, MD, chief medical officer, AF Solutions, Boston Scientific, said in a news release. "We look forward to studying the system in new clinical trials, including patients in need of redo ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation."1
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