Boston Scientific's FARAPULSE™ System Receives FDA Approval for Expanded Use in Atrial Fibrillation Treatment
Boston Scientific Corporation recently announced the FDA's approval for an expanded labeling of its innovative FARAPULSE™ Pulsed Field Ablation (PFA) System. This key development allows the system to be utilized in treating persistent atrial fibrillation (AF), a condition where the heart experiences abnormal rhythm for a minimum of a week, significantly complicating the lives of approximately 59 million patients worldwide. Persisting with symptoms such as dizziness, fatigue, shortness of breath, and heightened stroke risk, patients suffering from persistent AF now have an advanced treatment option that targets their specific needs.
The FARAPULSE PFA System operates by delivering precise bursts of energy through a catheter, effectively ablating cardiac tissue associated with abnormal electrical signals in the heart. The newly updated instructions for use (IFU) include approvals for both the FARAWAVE™ PFA Catheter and the FARAWAVE NAV™ PFA Catheter for these patients.
"With this update, we are not just making an incremental change; we are pushing the envelope forward in our mission to enhance the treatment landscape of atrial fibrillation, providing safer and more effective ablation technologies, which represent a crucial advancement for patient care," stated Dr. Brad Sutton, chief medical officer, AF Solutions at Boston Scientific.
The FDA's decision to approve the expanded labeling was based on robust clinical evidence derived from phase one of the ADVANTAGE AF clinical trial. This trial was presented at the AF Symposium 2025, with subsequent publication in the Journal of the American College of Cardiology. In this single-arm trial, 260 patients who were intolerant to at least one Class I/III anti-arrhythmic drug (AAD) were enrolled at 43 sites globally. The results were promising; notably, there were no recorded incidents of stroke, pulmonary vein stenosis, atrio-esophageal fistula, or major access complications. Furthermore, the symptomatic AF recurrence-free rate stood impressively at 85.3%. For physicians who performed three or more procedures, this rate increased significantly to 91.4%.
Looking ahead, Boston Scientific anticipates receiving similar approvals from CE and aims for market entry in Japan and China within the coming months. In its ongoing commitment to clinical excellence, the company has initiated the ReMATCH IDE clinical trial. This study will involve approximately 375 patients across 40 centers in the United States and Asia, aiming to evaluate the safety and effectiveness of the FARAWAVE PFA Catheter specifically for posterior wall ablation and pulmonary vein isolation in patients with persistent AF who have experienced a recurrence after prior ablation therapy.
In addition, the trial will explore the adjunctive use of the FARAPOINT™ PFA Catheter for ablation procedures that target specific heart structures alongside the main treatment.
Boston Scientific continues to lead the field of medical technology, improving the quality of life for patients through its innovative solutions uniquely designed for complex cardiovascular, respiratory, digestive, oncological, neurological, and urological disorders. The FARAPULSE PFA System is a testament to this commitment, showcasing how advanced technology can tackle significant health challenges, paving the way for improved patient outcomes in the intricate realm of atrial fibrillation care. For further details on the FARAPULSE™ PFA System, please visit Boston Scientific's website.