Medical Device Network

Boston Scientific’s Farapulse PFA system receives approval in Japan

The Farapulse PFA system provides a non-thermal approach for ablating heart tissue related to atrial fibrillation.

Boston Scientific has announced the approval of its Farapulse pulsed field ablation (PFA) system by the Pharmaceuticals and Medical Device Agency (PMDA) in Japan.

This system is a new option for the treatment of paroxysmal atrial fibrillation (AF), designed to isolate pulmonary veins without the use of extreme heat or cold.

AF can increase the risk of stroke, death and heart failure, and affects more than one million individuals in Japan and an estimated 38 million people worldwide.

The Farapulse PFA System offers a non-thermal solution to ablate cardiac tissue associated with AF, potentially reducing damage to surrounding structures.

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 – and we look forward to bringing this differentiated technology to Japan.”

Boston Scientific is bolstering its clinical evidence for the Farapulse PFA system with the upcoming OPTION-A clinical trial.

Set to begin early next year, the study will evaluate the safety and efficacy of procedures combining the Farapulse PFA system with the WATCHMAN FLX Pro left atrial appendage closure device. The trial will take place in Japan, China, Taiwan, and Hong Kong.

The company is preparing to launch the Farapulse PFA system in Japan shortly, following the approval of reimbursement.

Tokyo Medical University Hospital Heart Rhythm Centre director and cardiology department professor Dr 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.”