Boston Scientific Receives Japanese Regulatory Approval for the FARAPULSE™ Pulsed Field Ablation System

MARLBOROUGH, Mass., Sept. 27, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) 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.

"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."

AF can lead to increased risk of death, stroke and heart failure1 and affects more than one million people in Japan,2 while worldwide AF prevalence is conservatively estimated to impact 38 million individuals.3 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.

"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.

Boston Scientific plans to launch the FARAPULSE PFA System in Japan in the coming weeks, following reimbursement approval. More information on the FARAPULSE PFA System is available here.

About Boston Scientific
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, we 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. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.

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1 Bordignon S, Chiara Corti M, Bilato C. Atrial Fibrillation Associated with Heart Failure, Stroke and Mortality. J Atr Fibrillation. 2012 Jun 15;5(1):467. doi: 10.4022/jafib.467. PMID: 28496747; PMCID: PMC5153082.

2 Ohsawa M, Okayama A, Sakata K, Kato K, Itai K, Onoda T, Ueshima H. Rapid increase in estimated number of persons with atrial fibrillation in Japan: an analysis from national surveys on cardiovascular diseases in 1980, 1990 and 2000. J Epidemiol. 2005 Sep;15(5):194-6. doi: 10.2188/jea.15.194. PMID: 16195640; PMCID: PMC7904304.

3 Lippi G, Sanchis-Gomar F., et al. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021; Feb 16:217-221.

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