ADVANTAGE AF Study Phase 2 on FARAPULSE™ System Achieves Safety and Efficacy Goals

Boston Scientific Corporation has announced promising results from the second phase of the ADVANTAGE AF clinical trial, which examined the FARAPULSE Pulsed Field Ablation (PFA) System and the FARAPOINT PFA Catheter in treating persistent atrial fibrillation (AF). The findings were shared at the PFA Live Case Summit in San Diego and published in the journal Circulation.

The FARAPULSE PFA System is specifically designed for isolating pulmonary veins in the treatment of atrial fibrillation that is resistant to medication, offering a novel approach compared to traditional thermal ablation. Persistent AF is a condition that affects about one-fourth of AF patients, characterized by rapid heartbeats lasting over a week, often leading to risks such as blood clots and stroke.

The study explored the use of the FARAWAVE PFA Catheter for pulmonary vein isolation and posterior wall ablation, and the FARAPOINT PFA Catheter for cavotricuspid isthmus (CTI) ablation to treat atrial flutter, a type of heart rhythm disorder. Post-procedure, all patients were monitored using the LUX-Dx Insertable Cardiac Monitor System to track cardiac arrhythmias and assess AF burden.

The trial achieved all pre-set safety and efficacy goals, with notable outcomes including 73.4% of patients remaining free from AF, atrial flutter, and atrial tachycardia, surpassing the target of 40%. The safety event rate was low at 2.4%, and there were no reports of complications like pulmonary vein stenosis or atrio-esophageal fistula. Additionally, 81.0% of participants showed no symptomatic recurrence of documented AF, and 71.6% of them experienced significantly reduced atrial arrhythmia burden, correlating with improved quality of life. Impressively, 96.4% of those treated with the FARAPOINT PFA Catheter exhibited no recurrence of atrial flutter.

Dr. Vivek Reddy, the principal investigator, emphasized the benefit of continuous rhythm monitoring in the study, which provided detailed insights into patients' heart rhythms post-ablation, including asymptomatic recurrences often missed in typical clinical trials. This data supports the FARAPULSE PFA System as a safe and effective treatment for persistent AF patients.

The study was a prospective, single-arm trial involving 255 patients across 29 sites in the United States. Among these patients, 141 also received CTI ablation with the FARAPOINT PFA Catheter. This catheter is notable for its navigation capabilities and smaller ablation footprint, allowing for precise lesion creation during procedures.

Brad Sutton, Chief Medical Officer of AF Solutions at Boston Scientific, highlighted the importance of these results in advancing the FARAPULSE PFA System and expanding the company's product offerings for AF treatment. The trial's success signals potential for the FARAWAVE and FARAPOINT PFA Catheters and the LUX-Dx ICM System in providing comprehensive treatment options for the increasing number of AF patients.

Boston Scientific is seeking U.S. Food and Drug Administration approval to broaden the labeling for the FARAPULSE PFA System to include persistent AF. The company also anticipates regulatory approvals in the U.S. and Europe for the FARAPOINT PFA Catheter by late 2025. These developments reflect Boston Scientific's commitment to innovation and improving patient care through advanced medical technologies.