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Boston Scientific has received US Food and Drug Administration (FDA) approval for the Farapulse Pulsed Field Ablation (PFA) system for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (AF).

The PFA systems are an alternative to standard-of-care thermal ablation treatment. The Farapulse system is the second of this type of device to reach the US market, after the PulseSelect PFA system (Medtronic), which gained FDA approval for the treatment of both paroxysmal and persistent AF at the end of 2023. 

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. In contrast, PFA systems use tissue-selective, nonthermal electric fields to ablate heart tissue and avoid damage to surrounding structures. 

Positive 12-month data from the pivotal ADVENT clinical trial, the first randomized clinical trial to directly compare the efficacy and safety of the Farapulse system with standard-of-care ablation, showed 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, Boston Scientific reports. 

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, the company states. 

"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, in a Boston Scientific press 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," Reddy added. 

The Farapulse PFA 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 to provide safe and efficient access to the left side of the heart during procedures with the system, Boston Scientific notes. 

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, the company says.

Boston Scientific completed enrolment 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 AF, and commenced enrollment in a second phase of the study to evaluate the safety and effectiveness of adjunctive use of the Farapoint PFA catheter for cavotricuspid isthmus (CTI) 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 AF compared with antiarrhythmic drug therapy.

The Farapulse PFA system was granted Breakthrough Device Designation from the FDA's Center for Devices and Radiological Health in 2019 and received CE Mark approval in Europe in 2021. Boston Scientific plans to immediately launch the system in the United States.

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