Boston Scientific’s Farapulse PFA system receives expanded approval
Boston Scientific has received an expanded CE mark approval for its Farapulse Pulsed Field Ablation (PFA) system. The technology is now approved for the treatment of persistent atrial fibrillation (AFib) in addition to paroxysmal AFib.
“This approval represents an important step forward in addressing the evolving needs of the millions affected by persistent AFib across Europe, enhancing our ability to provide innovative solutions that improve patient outcomes,” Boston Scientific said as it announced the new approval on social media.
The Farapulse system first gained CE mark approval for treating paroxysmal AFib back in 2021. In fact, Boston Scientific officially became the first medtech company in the world to commercialize PFA when it secured that approval.
The decision to finally expand that indication to include persistent AFib was based largely on data from ADVANTAGE AF, a Boston Scientific-funded analysis of more than 300 patients. Vivek Reddy, MD, director of cardiac arrhythmia services for The Mount Sinai Hospital and a professor of electrophysiology at Icahn School of Medicine at Mount Sinai, was the lead author of a one-year analysis of the ADVANTAGE AF data. According to that one-year study, published in JACC in 2025, the procedure’s success rate was 99.7%, primary effectiveness rate was 63.5% and freedom from symptomatic AFib rate was 85.3%.[1]
PFA has been gaining considerable momentum in electrophysiology in the years since Boston Scientific gained that initial CE mark approval in 2021. The technology uses short electrical pulses to target AFib instead of ablation using extreme hot or cold temperatures.
The U.S. Food and Drug Administration (FDA) first approved the Farapulse system for treating paroxysmal AFib in early 2024. In July 2025, meanwhile, the FDA approved the technology for treating persistent AFib.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.