Boston Scientific Receives FDA Approval for Pulsed Field Ablation System

It's indicated for the isolation of pulmonary veins in the treatment of atrial fibrillation.

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Boston Scientific

Boston Scientific has received FDA approval for the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment.

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 PFA 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 – the first randomized clinical trial to directly compare 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.

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 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 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 to anti-arrhythmic drug therapy.

The FARAPULSE PFA System was granted Breakthrough Device Designation from the Center for Devices and Radiological Health (CDRH) of the U.S. 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.

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