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Boston Scientific Gets PMDA Approval in Japan for FARAPULSE PFA System

01 Oct 2024
Admin
News Article

Boston Scientific Gets PMDA Approval in Japan for FARAPULSE PFA System

Overview

Boston Scientific Corporation, a global medical technology leader, announced it has received Pharmaceuticals and Medical Device Agency (PMDA) approval in Japan for the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System, which is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation (AF), is a novel alternative to standard-of-care thermal ablation treatment.

Statement from Boston Scientific

"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," said Nick Spadea-Anello, president, electrophysiology, Boston Scientific. "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."

Paroxysmal Atrial Fibrillation: Consequences

AF can lead to increased risk of death, stroke and heart failure and affects more than one million people in Japan, while worldwide AF prevalence is conservatively estimated to impact 38 million individuals.
Unlike traditional thermal ablation, which uses extreme heat or cold to ablate cardiac tissue associated with AF, the FARAPULSE PFA System uses non-thermal electrical fields that avoid damage to surrounding structures.

From Tokyo Medical University Hospital

"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," said Kazuhiro Satomi, M.D., Ph.D., professor, Department of Cardiology and director, Heart Rhythm Center, Tokyo Medical University Hospital.
"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."

Adding to its robust body of clinical evidence for the FARAPULSE PFA System, Boston Scientific expects to initiate the OPTION-A clinical trial in Japan, China, Taiwan and Hong Kong in early 2025 to study the safety and efficacy of concomitant procedures using the FARAPULSE PFA System for cardiac ablation and the WATCHMAN FLX Pro Left Atrial Appendage Closure Device.

About Boston Scientific

Boston Scientific plans to launch the FARAPULSE PFA System in Japan in the coming weeks, following reimbursement approval.
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world.
As a global medical technology leader for more than 45 years, the company advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care.