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Boston Scientific receives FDA approval for expanded labeling of FARAPULSE™ Pulsed Field Ablation System
Prnewswire· 2025-07-07 19:00
The FDA approval for expanded labeling was supported by clinical evidence from phase one of the ADVANTAGE AF clinical trial presented at AF Symposium 2025 and recently published in the Journal of the American College of Cardiology and met both the primary safety and effectiveness endpoints. In the prospective, single-arm trial, 260 patients who were drug intolerant to at least one Class I/III anti-arrhythmic drug (AAD) were enrolled at 43 global sites. There were no reported incidences of stroke, pulmonary ...