The US Food and Drug Administration (FDA) approved Boston Scientific Corp’s Farapulse pulsed field ablation system, making it the second approval for this type of device. 

The Farapulse pulsed field ablation system is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation and is a new alternative to standard-of-care thermal ablation treatment.

Last December, the FDA approved the first pulsed field ablation system, Medtronic’s PulseSelect for the treatment of both paroxysmal and persistent atrial fibrillation. 

During a traditional ablation procedure, a catheter is guided to the interior of the heart and generates extreme temperatures—hot or cold—to destroy targeted areas associated with abnormal heart rhythms. The Farapulse system, however, relies on tissue-selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures. 

Positive 12-month data from the pivotal ADVENT clinical trial, a first randomized clinical trial comparing the efficacy and safety of the system against standard-of-care ablation, found that therapy with the device was as safe and effective as conventional thermal ablation, with statistically shorter ablation times and a quick learning curve for physicians. 

Additional real-world data from more than 17,000 patients in the MANIFEST-17K registry demonstrated continued real-world safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury.

“Within the ADVENT clinical trial, the Farapulse PFA system was shown to be a safe, effective and efficient option for treating paroxysmal [artial fibrillation], and extensive global real-world use has mirrored that profile,” says Vivek Reddy, MD, director of electrophysiology at Mount Sinai Fuster Heart Hospital, New York, in a release. “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.”

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The Farapulse system delivers pulsed field energy and consists of the Farawave Ablation Catheter, the Farastar Ablation Generator, and the Faradrive Steerable Sheath, which is complemented by the VersaCross Connect Access Solution for the Faradrive Steerable Sheath to provide safe and efficient access to the left side of the heart during procedures with the system. 

The Farawave catheter is used to treat a range of pulmonary vein anatomies using an over-the-wire catheter with variable basket and flower shapes, allowing the device to adapt to individual patient anatomies. These configurations reinforce ease of use for physicians and promote reproducible procedures between operators.

Boston Scientific completed enrollment in the first phase of the ADVANTAGE AF clinical trial in the third quarter of 2023, which is studying the system for the treatment of patients with drug-refractory, symptomatic, persistent atrial fibrillation, and commenced enrollment in a second phase of the study to evaluate the safety and effectiveness of adjunctive use of the Farapoint pulsed field ablation catheter for cavotricuspid isthmus ablations, a procedure used to treat atrial flutter. 

The company also recently commenced the AVANT GUARD clinical trial to evaluate the safety and efficacy of the system as a first-line treatment for persistent atrial fibrillation compared to anti-arrhythmic drug therapy.

The Farapulse system was granted Breakthrough Device Designation from the Center for Devices and Radiological Health of the FDA in 2019 and received CE Mark in 2021. 

Boston Scientific plans to immediately launch the system in the U.S. 

The company is developing a navigation-enabled version of the Farawave catheter alongside the Faraview software module and anticipates regulatory approval in 2024.

Photo caption: Farapulse pulsed field ablation system

Photo credit: Boston Scientific Corp