Boston Scientific is preparing to launch the Farapulse PFA system in Japan shortly. Credit: Boston Scientific Corporation.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”