Pulsed Field Ablation Devices Show Promise in Latest Clinical Trials

Pulsed field ablation (PFA) continues to gain traction as a preferred treatment for atrial fibrillation, with major medical device companies unveiling promising clinical trial results at the Heart Rhythm Society's 2025 annual meeting in San Diego. Boston Scientific, Medtronic, Abbott, and Johnson & Johnson all presented data supporting their PFA devices, showcasing advancements in safety and efficacy for both paroxysmal and persistent atrial fibrillation.

Boston Scientific's Farapulse System Demonstrates Strong Results

Boston Scientific's Advantage AF trial for its Farapulse PFA system and Farapoint PFA catheter met all safety and effectiveness goals at one year for patients with persistent atrial fibrillation. The study found that 73.4% of patients were free from AFib, atrial flutter, and atrial tachycardia, exceeding the goal of 40% or higher. The safety event rate was 2.4%, well below the 12% threshold.

The trial involved 255 patients at 29 U.S. sites, with 141 patients also receiving cavotricuspid isthmus ablation using the Farapoint PFA catheter to treat atrial flutter. Boston Scientific anticipates FDA approval for an expanded indication for Farapulse to include persistent AFib, as well as European and U.S. regulatory approvals for Farapoint in the second half of this year.

Abbott's Volt PFA System Shows Sustained Efficacy

Abbott presented one-year data from its CE Mark study for the Volt PFA system, demonstrating strong safety and efficacy results. The study of 150 patients at 11 European sites found that 83.5% of paroxysmal AFib patients and 58.1% of persistent AFib patients remained free from atrial arrhythmia. After 12 months, only 2.7% of Volt patients had experienced a primary safety endpoint event.

Abbott received Europe's CE mark for Volt in March and anticipates FDA approval in 2026. Christopher Piorkowski, chief medical officer of Abbott's electrophysiology business, stated that the latest data confirms the system's positive impact on patient care.

Medtronic Unveils Promising Results for Sphere-360 Catheter

Medtronic's next-generation Sphere-360 device, a single-shot PFA mapping and ablation catheter, showed freedom from arrhythmia recurrence in 88% of paroxysmal AFib patients at one year. The single-arm, multi-center trial conducted in European centers demonstrated durable pulmonary vein isolation in 98% of targeted veins and reported no safety events in a subgroup treated with the most optimized waveform.

The Sphere-360 catheter is integrated with Medtronic's Affera mapping and ablation system. The company plans to begin its U.S. pivotal trial for the Sphere-360 catheter later this year.

Johnson & Johnson Reports Initial Omnypulse Platform Results

Johnson & Johnson presented three-month results from the Omny-IRE study of its investigational Omnypulse platform for patients with paroxysmal atrial fibrillation. The data demonstrated 100% acute pulmonary vein isolation, with durable isolation in 84.5% of pulmonary veins at three-month remapping. The study showed a 3% primary adverse event rate, with 0.7% potentially catheter-related.

The Omnypulse platform consists of the Omnypulse focal PFA catheter and the Trupulse generator, integrated with the Carto 3 mapping system. The company recently resumed the use of its Varipulse PFA device in the U.S. after addressing safety concerns.

As PFA technology continues to evolve, these latest clinical trial results suggest a promising future for more efficient and safer treatments for atrial fibrillation. With multiple companies advancing their PFA systems, the competition is likely to drive further innovation and improvements in patient care.