The PFA system earned expanded labeling in Europe to include the treatment of persistent AFib, according to a LinkedIn post.
“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,” the account for Boston Scientific’s Cardiology unit posted.
Farapulse, a nonthermal PFA treatment, uses electric fields to selectively ablate heart tissue. It’s one of the leading PFA systems in a market that includes Medtronic, Johnson & Johnson MedTech, Abbott and Kardium.
The Farapulse system received expanded FDA labeling in July 2025 for treating drug-refractory, symptomatic persistent AFib. Boston Scientific shared findings from the ADVANTAGE AF trial in April 2025 that supported the expanded labeling. The company said today that ADVANTAGE AF data also supported the European label expansion.
ADVANTAGE AF demonstrated 73.4% freedom from AFib, atrial flutter (AFL) and atrial tachycardia (AT) at 12 months. That exceeded the performance goal of 40% or higher. The study also had a safety event rate of 2.4% with no reports of pulmonary vein stenosis, atrio-esophageal fistula or phrenic nerve palsy. That met the performance goal of 12% or lower.
Boston Scientific reports 81% freedom from symptomatic documented AFib recurrence. Additionally, 71.6% of patients had virtually no atrial arrhythmia (AA) burden.
