By Fineline Cube 
US-based Boston Scientific Corporation (NYSE: BSX) announced that it has received US FDA approval for label expansion relating to its FARAPULSE pulsed field ablation (PFA) system. The product can now be used to treat drug-refractory, symptomatic persistent atrial fibrillation (AF), a condition where the heart beats abnormally for at least seven days.
Mechanism and Approval
The FARAPULSE PFA system delivers pulsed electric field energy via a catheter to ablate heart tissue, thereby treating atrial fibrillation. This expanded approval is primarily supported by clinical evidence from the first phase of the ADVANTAGE AF trial, which met its primary safety and efficacy endpoints.
Clinical Trial Results
Results from the trial showed that no stroke, pulmonary vein stenosis, atrial-esophageal fistula, or major access complications occurred. The symptomatic AF recurrence-free rate was 85.3%. For operators who have performed three or more procedures, the freedom from persistent AF symptoms after FARAPULSE treatment increased to 91.4%.-Fineline Info & Tech