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The FARAPULSE PFA system has demonstrated safety and efficacy comparable to conventional thermal ablation methods in large pivotal trials. Real-world registry data from over 17,000 patients confirm a favorable safety profile with low rates of major complications. FDA approval was granted in early 2024 for paroxysmal AF; ongoing studies are evaluating broader uses including persistent AF and as a first-line therapy. Over $1 billion revenue was generated by Boston Scientific from this product in its first year post-FDA approval.
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