Boston Scientific Says FDA Approved FARAPULSE Pulsed Field Ablation System

(RTTNews) - Boston Scientific Corporation (BSX) Wednesday said the U.S. Food and Drug Administration (FDA) has approved the company's FARAPULSE Pulsed Field Ablation (PFA) System in the treatment of atrial fibrillation or irregular heart rhythm.

During a traditional ablation procedure, a catheter is guided to the interior of the heart and generates extreme temperatures to destroy targeted areas associated with abnormal heart rhythms. The FARAPULSE PFA System, however, relies on tissue-selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures.

Twelve-month data from ADVENT study, which was intended to compare the efficacy and safety of the PFA system against standard-of-care ablation, showed that therapy with the device was as safe and effective as conventional thermal ablation, with statistically shorter ablation times and a quick learning curve for physicians.

Additional real-world data from more than 17,000 patients in the MANIFEST-17K registry demonstrated continued real-world safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury.

Boston Scientific said it plans to immediately launch the system in the U.S.