- Boston Scientific (BSX, Financial) reports positive 12-month results from the second phase of the ADVANTAGE AF trial for the FARAPULSE™ Pulsed Field Ablation System.
- The trial exceeded performance goals with 73.4% freedom from AF, AFL, and atrial tachycardia.
- FDA approval for expanded use of the FARAPULSE PFA System is expected in the second half of 2025.
Boston Scientific Corporation (BSX) has announced encouraging 12-month results from the second phase of the ADVANTAGE AF clinical trial, assessing the FARAPULSE™ Pulsed Field Ablation System in patients with persistent atrial fibrillation. The trial significantly surpassed its performance goal with 73.4% of patients achieving freedom from atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT), compared to a target of 40%. The safety event rate was 2.4%, with no major complications reported, notably surpassing the 12% threshold.
Continuous cardiac monitoring after the procedure using the LUX-Dx™ Insertable Cardiac Monitor System revealed a 71.6% reduction in atrial arrhythmia burden, strongly suggesting improved quality of life and potential for fewer clinical interventions. The FARAPOINT™ PFA Catheter demonstrated a remarkable 96.4% effectiveness in preventing AFL recurrence among treated patients.
The trial involved 255 patients across 29 U.S. sites and included additional cavotricuspid isthmus (CTI) ablation for 141 of these patients using the FARAPOINT PFA Catheter. Boston Scientific anticipates receiving FDA approval for the use of the FARAPULSE PFA System in treating persistent AF by the second half of 2025, as well as regulatory approvals for the FARAPOINT PFA Catheter.
Persistent atrial fibrillation accounts for about 25% of all AF cases and poses risks such as stroke and heart failure. The trial results support the FARAPULSE PFA System as a safe and effective treatment option for these patients, potentially broadening the scope of therapy available to address persistent AF.
