Boston Scientific has received approval from the U.S. Food and Drug Administration (FDA) for the Farapulse Pulsed Field Ablation (PFA) System for isolating pulmonary veins in the treatment of drug-resistant, recurrent, symptomatic, paroxysmal atrial fibrillation (AF).
The PFA systems provide an alternative to traditional thermal ablation treatment. The Farapulse system is the second device of its kind to enter the U.S. market, following the PulseSelect PFA System (Medtronic), which received FDA approval for the treatment of paroxysmal and persistent atrial fibrillation at the end of 2023.
In a traditional ablation procedure, a catheter is inserted into the heart and extreme temperatures – hot or cold – are used to target specific areas associated with cardiac arrhythmias. In contrast, PFA systems use tissue-selective, non-thermal electrical fields to ablate heart tissue while avoiding damage to surrounding structures.
Positive 12-month data from the pivotal ADVENT study, the first randomized clinical trial to directly compare the efficacy and safety of the Farapulse system with standard ablation, showed that the device’s therapy was as safe and effective as traditional thermal ablation, with statistically shorter ablation times and a quick learning curve for physicians, according to Boston Scientific.
Additional real-world data from over 17,000 patients in the MANIFEST-17K registry demonstrated the ongoing real-world safety of the system, without any cases of permanent phrenic nerve palsy, pulmonary vein stenosis, or esophageal injury, the company reported.
„The clinical ADVENT study demonstrated that the Farapulse PFA system is a safe, effective, and efficient option for treating paroxysmal atrial fibrillation, and its widespread global use reflects this profile,“ said Vivek Reddy, MD, Director of Electrophysiology at Mount Sinai Fuster Heart Hospital, New York, in a Boston Scientific press release.
„Tissue preference and long-term effectiveness, combined with significantly shorter procedure times and learning curves, position the Farapulse PFA system with great potential to be a practice-changing technology for both U.S. physicians and patients,“ Reddy added.
The Farapulse PFA system delivers pulsed field energy and consists of the Farawave ablation catheter, the Farastar ablation generator, and the controllable Faradrive sheath, complemented by the VersaCross Connect Access Solution to enable safe and efficient access to the left heart during procedures with the system, according to Boston Scientific.
The Farawave catheter is used to treat a range of pulmonary vein anatomies, employing an over-the-wire catheter with variable basket and blossom shapes, allowing the device to adapt to the individual patient’s anatomy. These configurations enhance ease of use for physicians and promote reproducible procedures across operators, the company said.
Boston Scientific completed enrollment for the first phase of the ADVANTAGE AF clinical study in the third quarter of 2023, investigating the system for treating patients with drug-refractory, symptomatic, and persistent atrial fibrillation, and has begun recruitment for a second-phase study to evaluate the safety and efficacy of the additional use of the Farapoint PFA catheter for cavotricuspid isthmus (CTI) ablations, a procedure for treating atrial flutter.
The company has also recently commenced the AVANT GUARD clinical trial to assess the safety and efficacy of the system as a first-line treatment for persistent atrial fibrillation compared to antiarrhythmic drug therapy.
The Farapulse PFA system was granted Breakthrough Device Designation by 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 U.S.
In addition to the Faraview software module, the company is developing a navigable version of the Farawave catheter and expects regulatory approval in 2024.