SHERIDAN, WYOMING – May 6, 2025 – Boston Scientific has announced landmark 12-month results from the second phase of its ADVANTAGE AF study, revealing that the FARAPULSE™ Pulsed Field Ablation (PFA) System has successfully met all primary safety and efficacy endpoints in patients with persistent atrial fibrillation (AF). The data, unveiled at the PFA Live Case Summit in San Diego and published in Circulation, mark a strategic leap forward in the treatment of complex cardiac arrhythmias using non-thermal ablation technology.
Clinical Advancements in Treating Persistent AF
Persistent atrial fibrillation remains a high-risk cardiac condition associated with stroke, heart failure, and increased healthcare costs. Representing roughly 25% of all AF cases, persistent AF is notoriously difficult to manage. Boston Scientific’s ADVANTAGE AF trial evaluated its FARAWAVE™ and FARAPOINT™ PFA Catheters—both part of the FARAPULSE system—as targeted ablation tools for pulmonary vein isolation (PVI), posterior wall ablation (PWA), and cavotricuspid isthmus (CTI) ablation in patients with typical atrial flutter (AFL).
Trial results demonstrated:
- 73.4% freedom from AF, AFL, and atrial tachycardia (AT), exceeding the 40% performance threshold.
- 2.4% safety event rate, well below the 12% benchmark, with no reported cases of pulmonary vein stenosis, atrio-esophageal fistula, or phrenic nerve palsy.
- 81.0% freedom from symptomatic AF recurrence.
- 71.6% of patients experienced virtually no residual atrial arrhythmia burden.
- 96.4% of those treated with the FARAPOINT Catheter reported no recurrence of AFL.
“Continuous rhythm monitoring in phase two of the ADVANTAGE AF study allowed for a detailed picture of patients' cardiac rhythm after ablation, including asymptomatic AF recurrence, which is not often captured in U.S. Food and Drug Administration clinical trial monitoring but is important for the ability to provide more individualized care to patients,” said Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at Mount Sinai Health System and the study’s principal investigator. “The data collected in this trial continues to support the FARAPULSE PFA System as a safe and effective therapy, now with evidence highlighting positive results for its use in treating patients who suffer from persistent AF.”
Technology-Driven Precision and Real-Time Monitoring
The prospective, single-arm study enrolled 255 patients across 29 U.S. sites. All participants underwent continuous post-procedural monitoring with the LUX-Dx™ Insertable Cardiac Monitor (ICM), enabling precise detection of arrhythmia recurrence and AF burden.
Key technological highlights include:
- FARAWAVE PFA Catheter: Designed for broad-area ablation across PVI and PWA.
- FARAPOINT PFA Catheter: A precision catheter with a smaller ablation footprint for CTI ablation, integrated with the OPAL HDx™ Mapping System for enhanced visualization.
- LUX-Dx ICM System: Advanced implantable cardiac monitor for continuous arrhythmia tracking.
These innovations demonstrate the Boston Scientific commitment to leveraging next-generation cardiac electrophysiology tools for better clinical outcomes and more efficient healthcare delivery.
Strategic Positioning in a Growing Market
Boston Scientific’s latest findings position the FARAPULSE PFA System as a key player in the rapidly evolving electrophysiology market, where demand is surging for safer, non-thermal ablation technologies. The system’s performance in persistent AF—a more challenging subset of the arrhythmia spectrum—underscores its strategic value for providers seeking durable outcomes with reduced complications.
“These positive study results are an important step forward in the continued innovation of the proven FARAPULSE PFA System and our broader portfolio of products that treat AF,” said Dr. Brad Sutton, chief medical officer for AF Solutions at Boston Scientific. “The performance of the devices in this trial – the FARAPOINT and FARAWAVE PFA Catheters as well as the LUX-Dx ICM System – is an encouraging sign as we work towards expanding our portfolio to provide physicians with an even more robust toolset to treat the growing number of patients with AF.”
Regulatory Outlook and Market Expansion
Boston Scientific anticipates U.S. FDA approval for expanded indications for the FARAPULSE PFA System to include persistent AF later in 2025, alongside European and U.S. regulatory clearance for the FARAPOINT PFA Catheter. These approvals will mark critical milestones in commercializing a more versatile and effective AF treatment platform across key global markets.
To explore more about the ADVANTAGE AF trial and Boston Scientific’s electrophysiology portfolio, visit www.bostonscientific.com.