Boston Scientific Corporation announced positive 12-month results from the second phase of its ADVANTAGE AF clinical trial, showing that the FARAPULSE Pulsed Field Ablation (PFA) System successfully met all primary safety and efficacy endpoints in treating persistent atrial fibrillation (AF). The findings were presented at the PFA Live Case Summit in San Diego and simultaneously published in the journal Circulation.
The trial evaluated the FARAWAVE PFA Catheter for pulmonary vein isolation and posterior wall ablation, along with the FARAPOINT PFA Catheter for cavotricuspid isthmus ablation to treat typical atrial flutter. All 255 patients enrolled across 29 U.S. sites were continuously monitored post-procedure with the LUX-Dx Insertable Cardiac Monitor System.
Significant Clinical Outcomes
The study results demonstrated impressive efficacy, with 73.4% of patients achieving freedom from AF, atrial flutter (AFL), and atrial tachycardia (AT), substantially exceeding the performance goal of 40%. Safety outcomes were equally promising, with a low 2.4% safety event rate and no reports of serious complications such as pulmonary vein stenosis, atrio-esophageal fistula, or phrenic nerve palsy.
Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at Mount Sinai Health System and principal investigator of the study, emphasized the value of continuous rhythm monitoring used in the trial: "Continuous rhythm monitoring allowed for a detailed picture of patients' cardiac rhythm after ablation, including asymptomatic AF recurrence, which is not often captured in FDA clinical trials but is important for providing more individualized care to patients."
Additional findings revealed that 81% of patients remained free from symptomatic documented AF recurrence, while 71.6% had virtually no atrial arrhythmia burden. Among patients treated with the FARAPOINT PFA Catheter for atrial flutter, 96.4% experienced no recurrence.
Persistent AF: A Significant Clinical Challenge
Persistent AF, defined as an abnormal rapid heartbeat lasting at least seven consecutive days, accounts for approximately 25% of all AF cases. This condition can lead to serious complications including blood clots, stroke, and heart failure. Current treatment options for persistent AF are limited, making these results particularly significant.
The FARAPULSE PFA System represents an advancement in cardiac ablation technology. Unlike traditional thermal-based ablation methods, pulsed field ablation uses non-thermal electric fields to create more precise lesions while potentially reducing damage to surrounding tissues.
"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," Dr. Reddy noted.
Advanced Technology Integration
The FARAPOINT PFA Catheter used in the study is a navigation-enabled point catheter designed to create focal and linear-shaped lesions with a smaller ablation footprint. It integrates with Boston Scientific's OPAL HDx Mapping System to provide visualization of catheter placement during procedures.
Brad Sutton, M.D., chief medical officer of AF Solutions at Boston Scientific, commented on the significance of these results: "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. The performance of the devices in this trial 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 Future Implications
Boston Scientific anticipates FDA approval to expand the instructions for use labeling for the FARAPULSE PFA System to include persistent AF. The company also expects European and U.S. regulatory approvals for the FARAPOINT PFA Catheter in the second half of 2025.
The successful outcomes of this trial could significantly impact treatment options for patients with persistent AF, potentially offering a safer and more effective alternative to current therapies. The continuous monitoring approach used in the study also provides valuable insights into post-ablation arrhythmia patterns, which could help guide more personalized treatment strategies.
As atrial fibrillation continues to affect millions worldwide, with persistent AF representing a particularly challenging subset, these advances in ablation technology may represent an important step forward in addressing this growing public health concern.
