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Boston Scientific Says Farapulse Receives FDA Approval for Atrial Fibrillation
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Boston Scientific Says Farapulse Receives FDA Approval for Atrial Fibrillation
Jul 7, 2025 5:38 AM

08:14 AM EDT, 07/07/2025 (MT Newswires) -- Boston Scientific ( BSX ) said Monday the US Food and Drug Administration has approved expanded labeling for its Farapulse pulsed field ablation system to include pulmonary vein and posterior wall ablation in patients with persistent atrial fibrillation.

The company said the FDA approval updates the instructions for use for both the Farawave PFA catheter and the Farawave NAV PFA catheter to include persistent atrial fibrillation treatment.

The approval was backed by data from a phase 1 trial, which enrolled 260 patients and showed a symptomatic atrial fibrillation recurrence-free rate of 85.3%, Boston Scientific ( BSX ) said, adding the recurrence-free rate increased to 91.4% observationally among physicians who performed at least three procedures.

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