WASHINGTON (dpa-AFX) - 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.



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