FDA Approves Boston Scientific Pulsed Field Ablation System

Boston Scientific Corporation announced it has received FDA approval for its Farapulse Pulsed Field Ablation (PFA) system indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, intermittent atrial fibrillation.

The Farapulse PFA System relies on tissue-selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures. Positive 12-month data from the ADVENT clinical trial found that therapy with the device was as safe and effective as conventional thermal ablation, with statistically shorter ablation times, the company said.

The Farapulse PFA system received a CDRH Breakthrough Device Designation in 2019 and the European Economic Area CE Mark in 2021. Boston Scientific plans to immediately launch the system in the U.S.

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