FARAPULSE System Receives FDA Approval for the Treatment of Atrial Fibrillation

Boston Scientific, a global medical technology leader, announced the US Food and Drug Administration (FDA) approval of the FARAPULSE Pulsed Field Ablation (PFA) System for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (eg, intermittent) atrial fibrillation (AF). It is the first PFA system in the United States designed and built solely for this type of ablation therapy.

The FARAPULSE PFA System is a unique and novel alternative to standard-of-care thermal ablation treatment. Unlike traditional ablation procedures, which generate extreme temperatures (hot or cold) to destroy targeted areas associated with AF, FARAPULSE uses selective, nonthermal electric fields to ablate heart tissue and avoid damage to surrounding structures. Rigorous clinical trials and extensive real-world use of the system have exhibited long-term efficacy, as well as shorter procedure times and learning curves compared with conventional ablation modalities.

 The FARAPULSE PFA System was granted Breakthrough Device Designation from the FDA’s Center for Devices and Radiological Health in 2019 and received a CE Mark in 2021. Following the recent FDA approval, Boston Scientific plans to immediately launch the system in the United States.

The FARAPULSE PFA System works by delivering pulsed field energy and comprises the FARAWAVE Ablation Catheter, the FARASTAR Ablation Generator, and the FARADRIVE Steerable Sheath, which is complemented by the VersaCross Connect Access Solution to provide safe and efficient access to the left side of the heart during procedures.

“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 [United States],” said Nick Spadea-Anello, president, electrophysiology, Boston Scientific. “A high bar has been set by the 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.”

“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, MD, 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 US physicians and patients alike.”