#Japan #Tokyo #Boston Scientific #Atrial Fibrillation #FARAPULSE

Boston Scientific’s Revolutionary FARAPULSE PFA System

Boston Scientific Japan recently announced the new approval of its FARAPULSE™ Pulse Field Ablation (PFA) system for treating persistent atrial fibrillation (AF) on September 3. This significant approval will provide new treatment options for patients with persistent symptomatic AF, particularly those resistant to medications, expanding previous applications primarily focused on paroxysmal AF.

The FARAPULSE™ system employs electrical pulses instead of thermal energy for cardiac tissue ablation. This innovative approach aims to deliver a selective treatment that minimizes damage to crucial surrounding structures such as the esophagus and phrenic nerve, thereby ensuring enhanced safety and reproducibility during the procedure.

Dr. Kazuhiro Satomi, Chief of Cardiology at Tokyo Medical University Hospital, expressed the importance of this approval by stating, "FARAPULSE represents a significant innovation in the ablation techniques used for treating atrial fibrillation. The possibility to use it on persistent AF patients adds great value to the medical field. This system ensures a safer procedure with less effect on surrounding tissues compared to traditional thermal energy, making it a vital advancement in patient care. We hope it will bring about salvation for many patients moving forward."

Understanding Atrial Fibrillation

Atrial fibrillation is primarily classified into paroxysmal (intermittent) and persistent (continuous) AF. Paroxysmal AF often resolves spontaneously within a few days, returning to normal rhythm, but persistent AF lasts for more than seven days and may become long-standing if it continues longer than a year. According to registry data, about 55% of patients undergoing ablation in Japan in 2022 had paroxysmal AF, while the remaining 45% suffered from persistent AF. As the demand for treatment options rose, the need for the FARAPULSE system to address persistent AF became evident.

The newly approved indication also expands the application of the FARAPULSE PFA system, allowing not just pulmonary vein isolation but also isolation of the left atrial posterior wall for persistent AF treatment.

Clinical Evaluation

This approval was based on the results of the ADVANTAGE AF Phase I clinical trial, which had initially received FDA approval. The trial involved 260 patients with drug-refractory symptomatic persistent AF across 43 global sites, analyzing the system's safety and efficacy. The outcomes indicated a one-year procedural success rate of 63.5% for the primary efficacy endpoint, with a composite rate of severe adverse events at only 2.3%, successfully meeting set targets. No significant complications like stroke, pulmonary vein stenosis, or atrioesophageal fistula were reported, underscoring the system's safety profile.

Boston Scientific's Vision

Tomoyuki Morikawa, President of Boston Scientific Japan, emphasized their commitment to delivering safe and reliable treatments across Japan, stating, "We aspire to bring innovative solutions that enhance not just the delivery of healthcare but revolutionize it at its core. We are thrilled to broaden treatment options, improve care quality, and contribute positively to every patient’s journey through illness."

Boston Scientific has been at the forefront of providing innovative, evidence-based treatments for various cardiovascular conditions, including atrial fibrillation, myocardial infarction, angina, and sudden cardiac death. The FARAPULSE PFA system positions itself among these advanced solutions aiming to deliver safety and efficacy in patient care. As Japan prepares for a rapidly aging society, with projections estimating over 1 million AF patients by 2030, the adaptation of such transformative treatments becomes imperative.

The Way Forward

The FARAPULSE PFA system has been recognized in over 65 countries since its European launch in 2021 and has been clinically utilized over 200,000 times, supported by more than 120 peer-reviewed publications demonstrating its efficacy and safety. Following the regulatory approval in Japan on September 26, 2024, the broader rollout across the nation commenced on November 1, 2024, with further amendments expected to enhance its functionalities.

As a leading force in the cardiac disease treatment space, Boston Scientific is dedicated to continuing its innovative strides within the Japanese healthcare landscape, supplying advancements that enrich patients' lives and ensure optimal health outcomes.

For more information about Boston Scientific and its innovative healthcare solutions, visit Boston Scientific Japan.