Boston Scientific Corporation confirmed on Wednesday that its FARAPULSE Pulsed Field Ablation (PFA) System has been approved by the U.S. Food and Drug Administration for the treatment of atrial fibrillation, also known as irregular heart rhythm.
Unlike the traditional ablation procedure, which involves guiding a catheter to the heart's interior and generating extreme temperatures to eliminate areas linked with abnormal heart rhythms, the FARAPULSE PFA System employs tissue-selective, non-thermal electric fields. This method aims to ablate heart tissue while preventing damage to surrounding structures.
The efficacy and safety of the PFA system were examined in the ADVENT study. This compared the device to the standard-of-care ablation. The findings after twelve months indicated the PFA system was as safe and effective as the conventional thermal ablation. It also highlighted that the device had statistically shorter ablation times and physicians could quickly get to grips with it.
Moreover, additional real-world evidence from over 17,000 patients compiled in the MANIFEST-17K registry underscored the continuing safety of the system. There have been no reports of permanent phrenic nerve palsy, pulmonary vein stenosis, or esophageal injury.
Boston Scientific announced they are planning an immediate launch of the system in the U.S.
