Boston Scientific Launches FARAPULSE™ Pulsed Field Ablation System at the 35th Great Wall International Congress of Cardiology

On November 8, Boston Scientific launched the market introduction ceremony for its FARAPULSE™ series of pulsed field ablation (PFA) products (hereinafter referred to as "FARAPULSE series") at the 35th Great Wall Conference of Cardiology. In January this year, less than six months after receiving FDA approval in the United States, the FARAPULSE series obtained approval from China's National Medical Products Administration (NMPA). Since mid-September, the product has gradually been put into clinical use in China. Currently, several electrophysiology centers across China have performed FARAPULSE pulsed field atrial fibrillation ablation procedures.

Atrial fibrillation (AF) is one of the most common types of tachyarrhythmia. If patients do not receive effective treatment, it may significantly increase the risks of stroke and heart failure, and even lead to death. Large-scale epidemiological surveys show that there are approximately 12 million AF patients in China. As the aging population in China continues to deepen, the number of patients is expected to further increase in the future. Currently, catheter ablation is gradually becoming a first-line treatment for rhythm control in AF(1). Unlike traditional thermal ablation, the innovative pulsed field ablation (PFA) technology is becoming a cutting-edge trend in the field of catheter ablation globally due to its unique advantages in safety and efficacy. As the most researched and widely used PFA product worldwide, the FARAPULSE series has treated over 125,000 patients globally so far and represents the PFA technology with the most clinical evidence-based medical support currently available.

At the listing conference, several domestic electrophysiology experts shared their experiences of using the FARAPULSE series products in clinical practice, providing feedback on the safety, efficacy, and efficiency of the surgical procedures. Among them, multiple experts stated that FARAPULSE’s pulsed field ablation has ushered in a new era for atrial fibrillation (AF) ablation treatment. The "tissue selectivity" of pulsed field energy reduces the risk of damage to adjacent tissues during ablation. After a decade of research and optimization in catheter design, energy delivery, and standardized ablation protocols, FARAPULSE has been extensively validated by numerous studies to balance effective ablation with reduced side effects, giving physicians greater peace of mind during surgery and further decreasing complications associated with AF ablation. In the MANIFEST-17K registry study, real-world data from over 17,000 patients showed no reports of permanent phrenic nerve paralysis, pulmonary vein stenosis, or esophageal injury (2), fully demonstrating the safety of performing surgeries with the FARAPULSE series products.

The attending experts also discussed the effectiveness feedback of FARAPULSE during its clinical use at the conference. Several experts stated that the immediate pulmonary vein isolation rate was excellent after the standard 32-shot protocol. A series of clinical studies have also confirmed the effectiveness of using FARAPULSE products: the immediate pulmonary vein isolation rate during surgery reached 100%(3), the 3-month pulmonary vein re-isolation rate was 96%(4), and the one-year success rate of paroxysmal atrial fibrillation surgery was 90%(5).

At the launch event, Boston Scientific also presented the latest advancements in its PFA portfolio: In October this year, the FARAWAVE NAV cardiac pulsed field ablation (PFA) catheter* with magnetic mapping functionality received FDA approval in the United States, and the new FARAVIEW software module* obtained FDA 510(k) clearance. These two products are fully compatible with Boston Scientific’s existing cardiac mapping technologies and the company’s newly launched OPAL HDx mapping system*, providing visualization support for cardiac ablation procedures.

Zhang Jun, President of Boston Scientific Greater China, stated: "Boston Scientific is committed to transforming new ideas derived from the genuine needs of doctors and patients into breakthrough services and sustainable solutions. We are delighted to see that the FARAPULSE series has begun to deliver innovative clinical value to a wide range of patients in China and has received positive feedback from the industry as well as medical professionals and patients, showcasing the immense potential of this product to benefit even more patients. We look forward to the future iterations and upgrades of this product being launched in China as soon as possible, continuing to provide electrophysiologists and patients in China with a more reassuring, efficient, and effective atrial fibrillation surgery experience, contributing to alleviating the burden of atrial fibrillation in China."