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

Rhea-AI Summary

Boston Scientific (NYSE: BSX) has received PMDA approval in Japan for the FARAPULSE™ Pulsed Field Ablation (PFA) System. This system is indicated for the isolation of pulmonary veins in treating paroxysmal atrial fibrillation (AF). Unlike traditional thermal ablation, the FARAPULSE PFA System uses non-thermal electrical fields, avoiding damage to surrounding structures.

The system has been used to treat over 125,000 patients globally and is now approved in more than 65 countries. AF affects over one million people in Japan and an estimated 38 million worldwide. Boston Scientific plans to launch the system in Japan following reimbursement approval and expects to initiate the OPTION-A clinical trial in early 2025 to study concomitant procedures using the FARAPULSE PFA System and the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device.

Positive

• PMDA approval in Japan for the FARAPULSE™ PFA System
• System used to treat over 125,000 patients globally
• Approved in more than 65 countries
• Planned launch in Japan following reimbursement approval
• Initiation of OPTION-A clinical trial in early 2025

Negative

• None.

Insights

Medical Device Expert

The PMDA approval of Boston Scientific's FARAPULSE™ PFA System in Japan is a significant milestone for the company's electrophysiology portfolio. This novel technology offers a non-thermal alternative to traditional ablation methods for treating paroxysmal atrial fibrillation (AF), potentially reducing procedural risks and improving patient outcomes.

The system's strong clinical evidence and widespread adoption in over 65 countries suggest a paradigm shift in AF treatment. With more than 125,000 patients treated globally, the FARAPULSE PFA System has demonstrated a robust safety and efficacy profile, which could lead to increased market share and revenue growth for Boston Scientific in the lucrative Japanese medical device market.

The planned OPTION-A clinical trial, studying concomitant use with the WATCHMAN FLX™ Pro device, indicates potential synergies within Boston Scientific's product portfolio, which could further strengthen its competitive position in the cardiovascular space.

Market Research Analyst

The approval of the FARAPULSE™ PFA System in Japan opens up a substantial market opportunity for Boston Scientific. With over 1 million AF patients in Japan and a global AF prevalence of 38 million, the addressable market is significant. The rapid adoption in other countries suggests strong potential for market penetration in Japan as well.

This approval could lead to increased revenue streams and market share expansion in the $121.92 billion market cap company's electrophysiology segment. The upcoming launch, pending reimbursement approval, is likely to be a catalyst for stock performance in the near term.

Investors should monitor the reimbursement decision and initial adoption rates in Japan, as these factors will be important for the product's commercial success. The planned OPTION-A trial also presents a long-term growth opportunity, potentially expanding the system's indications and market reach.

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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CONTACTS:
Becca Johnson
Media Relations
Rebecca.johnson@bsci.com

Jon Monson
Investor Relations
+1 (508) 683-5450
BSXInvestorRelations@bsci.com

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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SOURCE Boston Scientific Corporation

FAQ

What is the FARAPULSE™ PFA System approved for in Japan?

The FARAPULSE™ PFA System has been approved by the PMDA in Japan for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation (AF).

How many patients have been treated with the FARAPULSE™ PFA System globally?

According to the press release, the FARAPULSE™ PFA System has been used to treat more than 125,000 patients globally.

When does Boston Scientific (BSX) plan to launch the FARAPULSE™ PFA System in Japan?

Boston Scientific plans to launch the FARAPULSE™ PFA System in Japan in the coming weeks, following reimbursement approval.

What clinical trial is Boston Scientific (BSX) planning to initiate for the FARAPULSE™ PFA System?

Boston Scientific expects to initiate the OPTION-A clinical trial in early 2025 to study concomitant procedures using the FARAPULSE PFA System and the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device.