Boston Scientific has announced that its FARAPULSE Pulsed Field Ablation (PFA) System, along with the FARAPOINT PFA Catheter, has met primary safety and efficacy endpoints in the second phase of the ADVANTAGE AF clinical study.
The trial focused on patients diagnosed with persistent atrial fibrillation (AF), a condition representing approximately 25% of all atrial fibrillation (AF) cases. Characterised by irregular heart rhythms persisting for at least seven consecutive days, persistent AF is known to increase the likelihood of stroke, heart failure, and other cardiovascular complications.
In this phase of the ADVANTAGE AF trial, the FARAWAVE PFA Catheter was employed for both pulmonary vein isolation and posterior wall ablation, while the FARAPOINT PFA Catheter was used for cavotricuspid isthmus ablation to address typical atrial flutter.
All participants underwent continuous post-procedure monitoring using the LUX-Dx Insertable Cardiac Monitor (ICM) System, which supports the identification of cardiac arrhythmias and tracks AF burden.
According to the published data, the trial achieved its pre-defined benchmarks for safety and effectiveness.
At the 12-month follow-up, 73.4% of the patient cohort remained free from atrial fibrillation, atrial flutter, or atrial tachycardia, surpassing the established threshold of 40%.
Safety outcomes included a 2.4% event rate, with no occurrences of pulmonary vein stenosis, atrio-oesophageal fistula, or phrenic nerve palsy, remaining well below the 12% safety threshold.
In addition, 81% of the patients exhibited no documented symptomatic recurrence of atrial fibrillation, defined by clinical intervention, arrhythmia detection, or escalated use of anti-arrhythmic therapies. Data also showed that 71.6% of patients experienced minimal atrial arrhythmia burden, while 52% had no residual events beyond the blanking period.
The FARAPOINT PFA Catheter achieved a 96.4% success rate in preventing recurrence of typical atrial flutter. Designed with a smaller ablation footprint to enable precision treatment, the catheter integrates with the Boston Scientific OPAL HDx Mapping System, which provides detailed imaging of catheter placement during procedures.
Boston Scientific AF solutions chief medical officer Brad Sutton said: “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 – 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.”
The single-arm study enrolled 255 patients across 29 clinical sites in the US. Of these, 141 received both pulmonary and CTI ablation using the FARAWAVE and FARAPOINT systems.
The trial’s findings underscore the potential application of non-thermal pulsed field ablation as an alternative to traditional thermal approaches for treating persistent atrial fibrillation and related rhythm disorders.
Boston Scientific indicated it is preparing to seek regulatory approval from the US Food and Drug Administration (FDA) to expand the current instructions for use of the FARAPULSE PFA System to include persistent atrial fibrillation. The company also expects to pursue European and US approvals for the FARAPOINT PFA Catheter in the second half of 2025.
