Pulsed Field Ablation Technology Cleared in Europe for Persistent AFib

Atrial fibrillation is a common heart rhythm disorder that can cause dizziness, fatigue, and shortness of breath and is associated with an increased risk of stroke. Persistent atrial fibrillation, defined as lasting at least seven days, presents a major management challenge for electrophysiology teams across Europe. An estimated 59 million people worldwide live with atrial fibrillation, many with the persistent form. A new European label expansion now enables a pulsed field ablation system to be used in patients with persistent atrial fibrillation.

Boston Scientific’s Farapulse pulsed field ablation platform has received CE mark approval for an expanded label that includes treatment of patients with persistent atrial fibrillation. The approval broadens prior European labeling that covered paroxysmal, or intermittent, atrial fibrillation. With this decision, the Farapulse procedure becomes available to treat patients in Europe who have the persistent form of the disease.

Pulsed field ablation is considered a safer alternative to thermal ablation methods for atrial fibrillation because it can reduce the risk of damage to surrounding tissue and shorten procedure times. The Farapulse system delivers pulsed electric fields to cardiac tissue to achieve targeted ablation, aiming to isolate arrhythmogenic substrates while limiting collateral effects. For hospital teams, the technique may streamline workflows by minimizing non-target tissue injury associated with conventional energy sources.

The expanded indication is supported by data from the ADVANTAGE AF clinical trial, which demonstrated the safety and effectiveness of Farapulse in patients with persistent atrial fibrillation. While detailed metrics were not disclosed in the announcement, the trial’s results underpinned the label expansion in Europe. This adds to a growing body of experience with pulsed field ablation in contemporary electrophysiology practice.

Farapulse previously received the CE mark in 2021 for paroxysmal atrial fibrillation and gained U.S. Food and Drug Administration clearance in January 2024 for that population. The European expansion to persistent atrial fibrillation follows a U.S. label expansion in July for the same patient group. Boston Scientific was the first of the major cardiac device manufacturers to offer a pulsed field ablation system in Europe following its 2021 acquisition of Farapulse.

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