Key takeaways:
- The FDA authorised an expanded indication for Boston Scientific’s pulsed subject ablation catheter for refractory, persistent AF.
- Approval was based mostly on the just lately printed outcomes of the ADVANTAGE AF trial.
Boston Scientific introduced the FDA approval of expanded labeling for its pulsed subject ablation system which now consists of remedy of drug refractory, symptomatic persistent atrial fibrillation.
The expanded approval for persistent AF updates the directions to be used for 2 of the corporate’s pulsed subject ablation catheter techniques (Farawave and Farawave Nav).
The approval for expanded labeling was based mostly on outcomes of the possible, single-arm, multicenter pivotal investigational gadget exemption trial ADVANTAGE AF, introduced at AF Symposium 2025 and printed within the Journal of the American School of Cardiology.
A complete of 339 sufferers with persistent AF present process pulmonary vein isolation and posterior wall ablation had been enrolled.
The first effectiveness endpoint included acute success and post-blanking 1-year freedom from atrial tachyarrhythmia recurrence, redo ablation, cardioversion or antiarrhythmic drug escalation.
PVI and posterior wall ablation had been profitable in 99.7% of sufferers, with a 63.5% incidence of the first effectiveness endpoint at 1 12 months.
As well as, 85.3% of sufferers had been free from symptomatic atrial fibrillation at 1 12 months, in response to the research.
“Backed by scientific proof and our world industrial expertise, this replace advances our efforts to additional form the way forward for AF remedy with protected and efficient ablation applied sciences,” Brad Sutton, MD, chief medical officer of AF Options at Boston Scientific, mentioned in an organization press launch. “We stay up for learning the system in new scientific trials, together with sufferers in want of redo ablations and people with extra advanced arrhythmias, which account for a big portion of the procedures at the moment nonetheless utilizing thermal ablation.”
The corporate additionally acknowledged within the launch plans for the ReMATCH IDE scientific trial, which can consider the protection and efficacy of pulsed subject ablation for sufferers with persistent AF who underwent prior pulsed subject, radiofrequency or cryoablation catheter ablation and skilled AF recurrence.
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