FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results

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."

ADVANTAGE AF trial drives expanded approval

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 this first phase of the trial, the primary safety endpoint of serious adverse events related to either the use of an ablation catheter or the ablation procedure within seven days of the primary procedure and pulmonary vein stenosis or atrio-esophageal fistula out to 12 months was met with an event rate of 2.3%.
• Farapulse met its primary effectiveness endpoint, with 63.5% of participants remaining free from AF-related events and interventions.
• 85.3% of patients had no recurrence of symptomatic AF; this rose to 91.8% when procedures were performed by more experienced physicians.
• No cases of stroke, major access issues, pulmonary vein narrowing, or atrio-esophageal fistula were reported.

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."

• This portion of ADVANTAGE AF was a single-arm, prospective trial.
• It included 260 participants enrolled across 43 global sites.
• The patient population was comprised of those who were drug intolerant to at least one Class I/III anti-arrhythmic drug.

Initial approval supported by ADVENT and real-world registry data

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 ADVENT, Farapulse was found to be as safe and effective as conventional thermal ablation.
• Data showed statistically shorter ablation times and a quick learning curve for physicians.
• Additionally, real-world data from the over 17,000 patients in the MANIFEST-17K registry demonstrated continued real-world safety of Farapulse, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis, or esophageal injury.

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."

References

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