Boston Scientific Completes First Rezūm Water Vapor Therapy Procedure in China Following NMPA Approval

GuangzhouJuly 5, 2022PR Newswire -- Recently, the first surgery using the Rezūm Thermal Vapor Therapy Device and the disposable prostate thermal vapor therapy device (referred to as: Rezūm System) from Boston Scientific Corporation (NYSE:BSX), a global leading medical technology company, was successfully completed at Sun Yat-sen Memorial Hospital of Sun Yat-sen University in Guangzhou after the product's registration approval in China. This marks the official entry of the product into clinical use in China. With advantages such as short operation time, quick recovery, ultra-minimally invasive, easy to learn and operate, the Rezūm System is expected to promote the outpatient treatment of benign prostatic hyperplasia surgeries, truly benefiting a large number of middle-aged and elderly male patients and contributing to the realization of "healthy aging."

Benign Prostatic Hyperplasia (BPH) is the most common benign condition causing urinary obstruction in middle-aged and elderly men. About 50% of men over 50 suffer from BPH, and the proportion rises to as high as 90% in men over 80.^[1]Professor Huang Jian, Director of the Department of Urology at Sun Yat-sen Memorial Hospital of Sun Yat-sen University and Chairman of the Urology Branch of the Chinese Medical Association, introduced: "China has about 72 million BPH patients, and more than 400,000 patients undergo BPH surgery each year, covering a very broad population. With the vigorous development of BPH surgeries, clinical practices have imposed higher demands regarding the learning curve for surgical techniques, postoperative trauma, risk, and management of complications. Additionally, patients who are dissatisfied with drug treatments or intolerant to existing surgical methods also require more minimally invasive and efficient approaches."

Against this backdrop, the Boston Scientific Rezūm System emerges as a groundbreaking solution. With 13 patented technologies, it utilizes the thermal energy of high-temperature water vapor to instantly cause the necrosis of prostate tissue cells affected by benign prostatic hyperplasia (BPH), which are then naturally absorbed by the body. This process achieves the goal of reducing prostate volume and improving clinical symptoms, with an average procedure time of just 5 to 8 minutes. Compared to the current gold standard for BPH treatment—transurethral resection of the prostate (TURP), which requires 1 to 2 hours of surgery and has a 5-year retreatment rate of 3% to 14.5%, the Rezūm procedure, lasting only a few minutes, boasts a 5-year retreatment rate of just 4.4%.^[2], and at the same time, the patient's sexual function can be well preserved after the operation.

Professor Huang Jian stated, "The thermal vapor therapy pioneered by the Rezūm system, as an ultra-minimally invasive procedure, is suitable for a wide range of prostate hyperplasia volumes. It not only has proven efficacy but is also easy to learn and operate, allowing it to be performed in outpatient or day surgery settings, effectively enhancing medical efficiency and conserving medical resources."

During this surgical procedure, Prof. Rahul Mehan from the East Valley Urology Center in Arizona, USA, an overseas expert with extensive experience in Rezūm surgery, provided real-time communication and support throughout the operation via video link. After the surgery, he also conducted case discussions and shared experiences with Chinese experts regarding the treatment and application of the Rezūm system overseas.

Professor Jiang Chun from Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, is performing surgery.

"As the surgeon who performed this operation, Professor Jiang Chun, Chief Physician of the Urology Department at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, summarized after the surgery: 'The patient treated in this operation is 75 years old, with a main complaint of difficulty in urination, frequent urination, and increased nocturia for three years, and the symptoms have worsened in the past month, causing great distress. During the treatment, we injected high-temperature water vapor at four points, with a total operation time of 2 minutes and 30 seconds, and there was almost no bleeding throughout the procedure. After completing the injection, we inserted a urinary catheter for the patient, and that completely concluded the procedure. The entire surgical process took less than 10 minutes and went very smoothly.'"

Moreover, Professor Jiang Chun stated that the global surgical volume of Rezūm has exceeded 100,000 cases, and clinical data has proven its safety and effectiveness.^[3]Moreover, it has already become an outpatient surgery in developed countries. Patients can go home once the treatment is finished and they don't even need to come back to the clinic to have their urinary catheter removed — they can remove it themselves a few days later. The best results are usually achieved three months after the treatment." Personally, I think Rezūm is particularly suitable for two groups of people: one is high-risk patients, as it can reduce the occurrence of anesthesia-related and surgical accidents; the other group is younger patients who have higher requirements for sexual and ejaculatory functions," said Professor Jiang Chun.

Professor Jiang Chun from Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, is performing surgery.

The rapid launch of the Rezūm system in mainland China for clinical use is also attributed to the policy boost from the "Double Ninth Articles," as well as the accelerated implementation of the "Real-World Data Research" pilot program in Boao Lecheng International Medical Tourism Pilot Zone, Hainan. In December 2020, the first "Pilot Trial" surgery using Rezūm was performed in Lecheng, marking the start of the real-world research project. Within less than 15 months, in March 2022, the system received registration approval from the National Medical Products Administration.

Zhang Jun, President of Boston Scientific Greater China, stated: "We are very pleased to see the first innovative product approved through the Boao real-world study officially entering clinical application in mainland China. This is a phased achievement of our deep cultivation of the local market and acceleration of introducing global medical innovations. We hope that with the widespread clinical application of the Rezūm system, we can provide more urologists with an effective treatment tool, offer patients more efficient and minimally invasive solutions, promote the shift of benign prostatic hyperplasia surgery in China towards day surgery and outpatient procedures, and help improve the utilization of medical resources."

*Registration Certificate No.: Thermal vapor therapy device, China Medical Device Registration Import 20223090122; Disposable prostate thermal vapor therapy device, China Medical Device Registration Import 20223090123