Boston Scientific Launches REPLACE Real-World Study of FARAPULSE PFA System in China

Boao, HainanMarch 12, 2023PR Newswire -- Today, Boston Scientific Corporation (NYSE: BSX) announced the official launch of the real-world study (referred to as the "REPLACE Study") on the use of the FARAPULSE Pulsed Field Ablation (PFA) System in patients with paroxysmal atrial fibrillation in China. This marks another milestone in clinical application at the Boao Lecheng International Medical Tourism Pilot Zone (referred to as "Lecheng Pilot Zone") in Hainan, within less than a month after completing the first "pilot trial" surgery in mainland China. It also signifies that the FARAPULSE PFA System has begun clinical data observation in the Chinese population, which is expected to accelerate its market approval process in China.

Professor Chen Minglong (right) leads team in completing FARAPULSE pulsed field ablation system "pilot" surgery

The FARAPULSE PFA System REPLACE study, led by Professor Chen Minglong from Jiangsu Provincial People's Hospital, is now underway. Earlier, the project held its center initiation meeting at the end of February and began patient recruitment and enrollment in the Lecheng Pilot Zone. Today, Professor Chen Minglong, along with Director Yang Gang and Director Ju Weizhu, successfully performed "pilot" surgeries on three patients with paroxysmal atrial fibrillation at Boao Super Hospital, officially enrolling them into the REPLACE study.

Post-operation, Professor Chen Minglong gave full affirmation to the FARAPULSE PFA System. He stated: "The unique ablation catheter design of the FARAPULSE PFA System allows operators to flexibly adjust it into two structures, 'petal' and 'basket,' during surgery. Its optimized energy delivery mode also helps reduce thermal ablation complications. Using the FARAPULSE PFA System can enhance clinical operational flexibility and optimize surgical efficiency. I look forward to this innovative technology being launched in China as soon as possible, benefiting more Chinese atrial fibrillation patients."

Professor Chen Minglong from Jiangsu Provincial People's Hospital

As the first medical device enterprise partner in the Real-World Research field of Lecheng Pilot Zone, Boston Scientific Corporation upholds the vision of "bringing global innovations to market simultaneously in China." In recent years, it has continuously strengthened its cooperation with Lecheng Pilot Zone. Recently, at the 2023 International Innovative Pharmaceutical and Medical Device Enterprise Exchange Conference, Boston Scientific was awarded the "Pioneering Innovation Award" and the "Lecheng Brand Co-building Award" by Lecheng Pilot Zone. Currently, several international innovative products from Boston Scientific have leveraged the favorable policies of "pilot first" and real-world research to enter the "fast track" for introduction into China. Previously, the FARAPULSE PFA System had been approved by the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) to enter the special review process for innovative medical devices (also known as the "green channel"). The official launch of the real-world study of the FARAPULSE PFA System will benefit more Chinese patients with atrial fibrillation, allowing them to access the world's most advanced innovative medical devices without leaving the country and accelerate China’s entry into the era of pulsed field ablation for atrial fibrillation treatment.

FARAPULSE Pulsed Field Ablation System (*This product has not yet been launched in mainland China)

About Boston Scientific

Boston Scientific Corporation is committed to innovation for life. We are dedicated to innovative medical solutions that improve the lives of patients around the world. For more than four decades, Boston Scientific has been at the forefront of the global medical technology industry, providing a wide range of high-performance medical solutions to meet the urgent needs of patients, while reducing healthcare costs. For more detailed information, please visit the company's website:www.bostonscientific.cn

About Boston Scientific Greater China

Boston Scientific established its China headquarters in Shanghai in 1997 and currently has branches in Beijing, Guangzhou, Chengdu, Hong Kong, and Taiwan. The company's core business areas cover cardiac intervention, structural heart disease, cardiac rhythm management and electrophysiology, endoscopic intervention, peripheral and tumor intervention, urology, respiratory products, and more. Upholding the tradition of being an innovation leader, Boston Scientific is committed to becoming a respected medical technology company that meets the needs of doctors and patients, demonstrates innovative vitality, and provides high-quality medical products and services for prevention, diagnosis, and treatment. For more detailed information, please visit the company’s website:www.bostonscientific.cn