Boston Scientific Corporation Announces Positive 12-Month Results from ADVANTAGE AF Clinical Trial
Boston Scientific Corporation announced positive 12-month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial. The trial evaluated the FARAPULSE™ Pulsed Field Ablation (PFA) System and adjunctive use of the FARAPOINT™ PFA Catheter in patients with persistent atrial fibrillation (AF). The trial’s findings were presented at the second annual PFA Live Case Summit in San Diego and simultaneously published in Circulation.
Positive Results for Treating Persistent Atrial Fibrillation
The highlighted results indicate that the FARAPULSE PFA System is a safe and effective therapy for treating patients who suffer from persistent AF. The study addressed persistent AF, an abnormal, rapid heartbeat condition that lasts for at least seven days in a row. This condition accounts for approximately 25% of all AF cases and can lead to complications such as blood clots, stroke, and heart failure.
Study Details and Findings
The second phase of the ADVANTAGE AF trial studied the FARAWAVE™ PFA Catheter for both pulmonary vein isolation (PVI) and posterior wall ablation (PWA) and the FARAPOINT PFA Catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter (AFL), a type of heart rhythm disorder. The trial’s patients were continuously monitored after their procedure with the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, designed to detect recurrence of cardiac arrhythmias and assess AF burden.
Findings from the trial met all pre-specified safety and effectiveness endpoints and demonstrated:
– 73.4% freedom from AF, AFL and atrial tachycardia (AT), exceeded the performance goal of 40% or higher.
– A safety event rate of 2.4% and no reports of pulmonary vein stenosis, atrio-esophageal fistula or phrenic nerve palsy, met the performance goal of 12% or lower.
– 81.0% freedom from symptomatic documented AF recurrence, defined as arrhythmia, clinical intervention or use of escalated or new Class I/III anti-arrhythmic drugs.
– 71.6% of patients had virtually no atrial arrhythmia (AA) burden, where data shows lower AA burden can be associated with fewer clinical interventions and improvements in quality of life.
– 96.4% of patients treated with the FARAPOINT PFA Catheter had no recurrence of AFL.
Future Plans and Approvals
Boston Scientific is working towards expanding its portfolio to provide physicians with a robust toolset to treat the growing number of patients with AF. The company anticipates U.S. Food and Drug Administration approval to expand the instructions for use labeling for the FARAPULSE PFA System to include persistent AF as well as European and U.S. regulatory approvals for the FARAPOINT PFA Catheter in the second half of 2025.
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