Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
The expanded FDA approval of Farapulse introduces a non-thermal ablation option for persistent AF, potentially shifting treatment pathways and protocol design.
ADVANTAGE AF data reinforce the importance of operator experience in outcomes, highlighting a growing need for targeted training in emerging PFA technologies.
The single-arm trial design and reliance on global site participation offer insights into future site selection and scalability for complex arrhythmia studies.
The FDA has expanded the label for Boston Scientific Corporation’s Farapulse Pulsed Field Ablation (PFA) System based on positive data from the ADVANTAGE AF clinical trial (NCT05443594). The system is now approved for the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF).1
In a press release, Brad Sutton, MD, chief medical officer, AF Solutions, Boston Scientific, said: "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. We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation."
This new indication is based on encouraging 12-month outcomes from the first phase of ADVANTAGE AF, which Boston Scientific initially shared at AF Symposium 2025 in January.2
In an earlier press release announcing this data, Vivek Reddy, MD, director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York and study principal investigator, said: "In addition to the positive safety and efficacy outcomes achieved in the ADVANTAGE AF study, a significant number of patients were able to discontinue AADs as well as see greater improvements in quality of daily life. As the population of patients living with AF continues to grow, data from trials such as ADVANTAGE AF further support the paradigm shift to PFA as a treatment for patients who are living with persistent and other complex forms of AF."
Farapulse was initially approved by the FDA for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) AF in January 2024. This approval was based on 12-month results from the ADVENT clinical trial (NCT04612244). According to Boston Scientific, ADVENT was the first randomized clinical trial to directly compare the efficacy and safety of the system against standard-of-care ablation.3
In a press release from the time of this approval, Reddy said: "Within the ADVENT clinical trial, the Farapulse PFA System was shown to be a safe, effective and efficient option for treating paroxysmal AF, and extensive global real-world use has mirrored that profile. Tissue preferentiality and long-term efficacy, combined with markedly shorter procedure times and learning curves, position the Farapulse PFA System with strong potential to become a practice-changing technology for both US physicians and patients alike."
1. Boston Scientific receives FDA approval for expanded labeling of FARAPULSE™ Pulsed Field Ablation System. News release. Boston Scientific. July 7, 2025. Accessed July 7, 2025. https://www.prnewswire.com/news-releases/boston-scientific-receives-fda-approval-for-expanded-labeling-of-farapulse-pulsed-field-ablation-system-302498437.html#:~:text=MARLBOROUGH%2C%20Mass.%2C%20July%207,Field%20Ablation%20(PFA)%20System.
2. Late-breaking data presented at AF Symposium 2025 highlight key Boston Scientific therapies for management of patients with atrial fibrillation. News release. Boston Scientific. January 16, 2025. Accessed July 7, 2025. https://www.prnewswire.com/news-releases/late-breaking-data-presented-at-af-symposium-2025-highlight-key-boston-scientific-therapies-for-management-of-patients-with-atrial-fibrillation-302353739.html
3. Boston Scientific Receives FDA Approval for FARAPULSE™ Pulsed Field Ablation System. News release. Boston Scientific. January 31, 2024. Accessed July 7, 2025. https://www.prnewswire.com/news-releases/boston-scientific-receives-fda-approval-for-farapulse-pulsed-field-ablation-system-302048807.html
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