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Boston Scientific receives FDA approval for FARAPULSE Pulsed Field Ablation System

Press releases may be edited for formatting or style | February 01, 2024 Cardiology
MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment.

"The approval of the FARAPULSE PFA System marks an important milestone for the millions of people living with paroxysmal AF and is an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the U.S.," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. "A high bar has been set by performance of the system in clinical and commercial settings – where more than 40,000 patients have been treated to date – and we look forward to continuing to lead the way with this differentiated technology in the growing PFA space."

During a traditional ablation procedure, a catheter is guided to the interior of the heart and generates extreme temperatures – hot or cold – 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. Positive 12-month data from the pivotal ADVENT clinical trial – the first randomized clinical trial to directly compare the efficacy and safety of the system against standard-of-care ablation – found 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.

"Within the ADVENT clinical trial, the FARAPULSE PFA System was shown to be a safe, effective and efficient option for treating paroxysmal AF, and extensive global real-world use has mirrored that profile," said Vivek Reddy, M.D., director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York. "Tissue preferentiality and long-term efficacy, combined with markedly shorter procedure times and learning curves, position the FARAPULSE PFA System with strong potential to become a practice-changing technology for both U.S. physicians and patients alike."

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