The NMPA approved Shanghai Lixiao’s thermal vapor therapy equipment and the single-use prostate thermal vapor therapy device on February 28, 2026.
The thermal vapor therapy equipment consists of a main unit and a power cord. It is used in conjunction with the single-use prostate thermal vapor therapy device to alleviate symptoms and obstruction associated with benign prostatic hyperplasia (BPH). It is indicated for male patients aged 50 years and above with prostate volumes (with or without central zone and/or median lobe hyperplasia) ranging from 30 to 80 cm³.
The product features a spiral heating design, utilizing a heating control algorithm to continuously monitor steam temperature and pressure while adjusting output power in real time. It offers advantages such as minimally invasive procedure, reduced bleeding, and shorter operation time. This device is the first domestically manufactured product to employ thermal vapor therapy for treating benign prostatic hyperplasia, providing patients with additional treatment options.
The system was granted the Innovation Review status in December, 2024.
Review Reports for Boston Scientific’s Rezūm System
The NMPA granted approvals to Boston Scientific’s Rezūm Water Vapor Therapy equipment and its disposable prostate treatment accessory on March 3, 2022. It only took four months for the two devices from submitting the registration application to guaranteeing approval, through Hainan Real-World Data program.
Review Report: Rezūm Generator
Product Overview
– The Rezūm Generator is a Class III medical device comprised of a main unit and a power cord
– Designed for hospital use in conjunction with the Boston Scientific Rezum Delivery Device
– Indicated for male patients aged 50+ with prostate volumes between 30-80 cm³
– Works by converting sterile water into thermal vapor that is injected into prostatic tissue
– Thermal energy causes cell death and subsequent tissue absorption, reducing prostate volume
– Incorporates critical safety features including temperature sensing and automatic output cessation
Pre-clinical Study Overview
– Performance validated against established standards for flow rate, pressure, and temperature protection
– Software (three modules, version 3.0) validated according to NMPA guidelines
– Five-year product lifespan substantiated through aging and usage testing
– Safety confirmed through compliance with electrical safety standards (GB9706.1-2007, YY0505-2012)
– Animal studies on canine model showed effective prostate volume reduction with minimal tissue damage
Clinical Evaluation Overview
– Prospective, multi-center, single-blind, randomized controlled trial across 15 international sites
– 197 subjects enrolled (136 treatment, 61 control)
– Primary effectiveness endpoint: IPSS improvement at three months
– Treatment group: -11.2 points
– Control group: -4.3 points
– Statistical superiority established
– Primary safety endpoint: device-related serious complication rate of 0.7%, significantly below 12% target
– Secondary endpoints:
– Responder rate at 3 months: 77.94% (treatment) vs 34.43% (control)
– Responder rate at 6 months: 75.00%
– Responder rate at 12 months: 75.00%
– Long-term durability demonstrated through 5-year follow-up data
Product Benefit-Risk Assessment
– Comprehensive risk analysis conducted following YY/T0316-2016 standards
– Reasonable risk control measures implemented
– Residual risks within acceptable limits
– Benefits outweigh risks for target population
Review Report: Rezum Delivery Device
Product Overview
– Single-use, sterile Class III accessory designed specifically for Rezūm Generator
– Comprises treatment device, water delivery set, and needle hub
– Handle contains vapor generation components with internal heating coil
– Features channel for 4mm cystoscope allowing direct visualization
– Temperature sensors provide real-time feedback to generator
– Ethylene oxide sterilized with two-year shelf life
Pre-clinical Study Overview
– Mechanical performance, dimensional accuracy, and steam delivery parameters confirmed
– Biocompatibility testing per GB/T16886.1-2011 covered all patient-contacting materials
– Steam output chemically characterized to confirm no additional biological risks
– Sterilization validation and accelerated aging studies supported two-year shelf life
– Same animal study confirmed delivery device efficacy and safety profile
Clinical Evaluation Overview
– Same clinical trial design as generator evaluation
– Primary effectiveness endpoint achieved with statistical superiority
– Primary safety endpoint met with 0.7% complication rate
– Secondary endpoints all achieved with statistical significance
– Long-term efficacy demonstrated through 5-year follow-up data
Product Benefit-Risk Assessment
– Comprehensive risk analysis following YY/T0316-2016 standards
– Risk control measures appropriately implemented
– Residual risks within acceptable limits
– Benefits outweigh risks for indicated patient population
A More Gentle, Innovative Therapy
Benign prostatic hyperplasia (BPH) is a common condition among aging men, characterized by abnormal cell proliferation leading to prostate enlargement, bladder outlet obstruction, and lower urinary tract symptoms. In 2023:
– Global BPH prevalence: 120,684,005 cases
– Global new cases: 14,704,527
– China BPH prevalence: 25,649,289 cases
– China new cases: 3,493,467
The water vapor therapy technology employed by the Rezūm System offers a distinct advantage. By injecting small, precise amounts of sterile water vapor (up to 103°C) into the prostate transition zone, the vapor condenses and releases its thermal energy (around 70°C), causing immediate cell death in the targeted tissue. The body then absorbs the treated tissue, reducing prostate volume and relieving pressure on the urethra.
This convective heating mechanism spares surrounding structures, crucially preserving the nerves and muscle fibers essential for sexual function, making it a preferred option for sexually active men concerned about the risks of impotence or ejaculation loss associated with other treatments. Furthermore, the procedure can be performed in an outpatient setting, offering convenience and rapid recovery.
Top Companies of Thermal Vapor Therapy
Multiple global companies have developed and commercialized thermal vapor therapy system intended for BPH. They include:
- Francis Medical
- Olympus Medical Systems
- Wilson-Cook Medical
- Aqua Medical
- Creo Medical
- STERIS
- Sb-Kawasumi Laboratories
- … …
China Med Device, LLC has test engineers at NMPA testing centers and seasoned CRA and RA staff to expedite your clinical and regulatory process and shorten your approval time. Email info@ChinaMedDevice.com for more information