FDA Okays Boston Scientific PFA System for Paroxysmal AF

The Farapulse Pulsed Field Ablation (PFA) system by Boston Scientific has received FDA approval for treating drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (AF). This system is an alternative to standard thermal ablation, using tissue-selective, nonthermal electric fields to ablate heart tissue. Clinical trial data shows the Farapulse system is as safe and effective as traditional ablation, with shorter procedure times. Real-world data also demonstrates the system’s safety. The Farapulse system consists of the Farawave ablation catheter, Farastar ablation generator, Faradrive steerable sheath, and VersaCross Connect Access Solution. Boston Scientific is also conducting further clinical trials and is developing a navigation-enabled version of the Farawave catheter.

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