Boston Scientific has received Japan’s Pharmaceuticals and Medical Device Agency (PMDA) approval for its Farapulse Pulsed Field Ablation (PFA) system.
The system is indicated for the isolation of pulmonary veins in treating paroxysmal atrial fibrillation (AF).
According to the company, Farapulse is a novel alternative to standard-of-care thermal ablation treatment, which often leverages extreme heat or cold to ablate cardiac tissue.
Unlike traditional thermal ablation, it uses non-thermal electrical fields that prevent damage to the surrounding structures.
The system selectively ablates the myocardium to reduce the damage to the surrounding tissue and delivers durable transmural pulmonary vein (PV) lesions to limit redo procedures.
It adapts to variable patient PV anatomy for reproducible procedures, limits left atrium (LA) dwell time and creates effective workflows to simplify the procedure.
Boston Scientific plans to launch the Farapulse PFA system in Japan in a few weeks, after receiving reimbursement approval.
Boston Scientific electrophysiology president Nick Spadea-Anello said: “The Farapulse PFA System is the most clinically studied PFA system and its use in treating more than 125,000 patients globally to date continues to reinforce its strong safety, efficacy and efficiency profile.
“The rapid adoption of the Farapulse PFA System, which is now approved in more than 65 countries, indicates a paradigm shift for the treatment of paroxysmal AF, one that has clinical benefits to both physicians and patients.”
According to the company, AF affects more than one million people in Japan, leading to an elevated risk of death, stroke, and heart failure.
Its Farapulse PFA system has met all primary endpoints for safety and efficacy in the ADVENT clinical trial and showed positive results in the MANIFEST-17K Multicentre Registry.
Furthering the existing clinical evidence for the Farapulse system, Boston Scientific intends to begin the OPTION-A clinical trial in Japan, China, Taiwan, and Hong Kong, in early 2025.
The clinical trial will evaluate the safety and efficacy of concomitant procedures using the Farapulse PFA system and the WATCHMAN FLX Pro left atrial appendage closure device.
Tokyo Medical University Hospital Heart Rhythm Centre director, department of cardiology professor Kazuhiro Satomi said: “Clinical evidence and extensive real-world use have demonstrated the Farapulse PFA system to be an efficient and more predictable procedure than traditional thermal ablation and a proven safe technology.
“This technology has the potential to rapidly advance clinical practice and improve outcomes and is anticipated to further expand the range of treatment options for AF that can be tailored to each patient’s condition.”
