Boston Scientific's Rezūm Water Vapor Therapy System Achieves 'Double Hundred Cases' Milestone in China Clinical Application

ShanghaiNovember 28, 2022PR Newswire -- Boston Scientific (NYSE:BSX), a global leading medical technology company, has successfully completed 100 surgeries in mainland China following the approval of its Rezūm Thermal Vapor Therapy Device and Single-Use Prostate Thermal Vapor Therapy Instrument* (referred to as: Rezūm System) for the treatment of benign prostatic hyperplasia. This marks the second "100-case" application achieved domestically after the completion of the product's "Real-World Study" in Boao Lecheng Pilot Zone, Hainan, indicating that this globally pioneering innovative technology has begun to accelerate in benefiting Chinese patients.

More than half of men over 50 worldwide suffer from benign prostatic hyperplasia (BPH), with the prevalence rate reaching up to 90% in men over 80.^[1]Currently, the commonly used surgical or laser surgeries in clinical practice all aim to treat the condition by destroying the structure of benign prostatic hyperplasia (BPH), with each operation usually taking 1-2 hours. However, the "ultra-minimally invasive" therapy pioneered by the Rezūm system utilizes the release of thermal energy from high-temperature water vapor to instantly necrotize the tissue cells of the enlarged prostate, allowing them to be naturally absorbed by the body. This reduces the prostate volume and alleviates symptoms such as difficulty in urination, while effectively preserving the patient’s sexual function post-surgery. The average operation time is only 5-8 minutes, and can be completed under local anesthesia, making outpatient treatment for BPH possible. This greatly enhances medical efficiency, saves medical resources, and reduces the disease burden for a large number of middle-aged and elderly patients.

Professor Xue Wei, Vice President of Renji Hospital, Shanghai Jiao Tong University School of Medicine, and Director of the Urology Department"This is stated as follows: Benign prostatic hyperplasia has always been one of the key focuses for urologists. As China's population ages, an increasing number of middle-aged and elderly men are facing the unspoken hardships of frequent urination and urgency caused by prostate enlargement, and long-term medication is a significant burden on both patients and society as a whole. We are pleased to see that intervention techniques for prostate enlargement have moved from minimally invasive treatments into ‘ultra-minimally invasive treatments,’ especially with good preservation of sexual function, which also brings good news to relatively younger patients."

From December 2020 to the present, the Remo system has benefited over 120 Chinese patients in advance through clinical use in Boao Lecheng Pilot Zone, taking advantage of the "pilot first" and real-world study policy opportunities. During this time, it set a record for the shortest operation time of 1 minute and 35 seconds. In March 2022, supported by real-world data research, the product officially gained approval from the National Medical Products Administration (NMPA) to enter the Chinese market.

In response to this,Fu Zhu, Deputy Director of the Administration Bureau of Boao Lecheng International Medical Tourism Pilot Zone in Hainan, and Deputy Director of the Hainan Provincial Real-World Data Research Institute"It shows that 'Rezum' is the first device and treatment instrument of Boston Scientific to be specially used in the Lecheng Pilot Zone. It took only a few months from the acceptance of registration to the official approval, fully demonstrating the efficient support of Lecheng's real-world research for the registration and listing of innovative drugs and devices in China. It also reflects that the Lecheng Pilot Zone, as a window and acceleration channel connecting with top international medical resources, can allow global cutting-edge products to benefit patients in China faster, earlier, and more extensively."

In July this year, the first surgery using the ReDream system was successfully performed in China following its approval. The first commercial device in China was subsequently installed in August at Shanghai Xinrui Medical Center under ParkwayHealth. To date, over 100 clinical applications have been conducted in China.

Zhang Jun, President of Boston Scientific Greater China, stated: "Boston Scientific has been very fortunate to receive meticulous guidance and strong support from urology experts across China, the Management Bureau of Boao Lecheng Pilot Zone in Hainan, and the leadership of the National Medical Products Administration's Center for Medical Device Evaluation during the real-world study and registration of Rezūm, as well as the promotion and market launch of this innovative therapy. As a result, many patients suffering from benign prostatic hyperplasia (BPH) symptoms can now regain a high-quality, happy life through a less invasive and safer surgical approach. In the future, Boston Scientific will continue to focus on introducing more cutting-edge medical technologies into China, exploring richer and more diverse localization models, and benefiting more patients across the vast land of China."

*Registration Certificate No.: Thermal Steam Treatment Device, Imported Medical Device Registration (China)20223090122; Single-use Prostate Thermal Vapor Therapy Device, Registered in China20223090123

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 worldwide. For more than four decades, Boston Scientific has consistently led the global medical technology industry by delivering a wide range of high-performance medical solutions that meet the urgent healing needs of patients and reduce healthcare costs. For more 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 Taipei. The company's core businesses cover cardiac intervention, structural heart disease, cardiac rhythm management and electrophysiology, endoscopic intervention, peripheral and tumor intervention, urology and pelvic floor health, respiratory products, and more. Upholding its tradition as 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

^[1] Bin LK. Epidemiology of clinical benign prostatic hyperplasia. Asian J Urol. Elsevier Ltd. 2017;4(3):148–51.