Boston Scientific's Rezūm System and Single-Use Prostate Steam Treatment Device Approved in China Using Real-World Data from Boao Lecheng

New Hainan Client, Nanhai Net, Nanguo Metropolis Daily, March 5th, by reporter Gui Chu Su — The Boao Lecheng Clinical Real-World Data Application Pilot has once again achieved a new breakthrough. The reporter learned from the Lecheng Pilot Zone Administration that, after review, the National Medical Products Administration has approved the registration application for Boston Scientific Corporation's Rezūm System and its disposable prostate thermal vapor therapy device. Following the approval of the glaucoma drainage tube and the femtosecond laser ophthalmic treatment system, these are the next two devices to be approved in Hainan’s Boao Lecheng Pilot Zone.Innovative HealthcareInstrument products.

Boston Scientific Thermal Vapor Therapy Device and Single-Use Prostate Thermal Vapor Therapy Instrument

The operation time is only 5-8 minutes.

This product uses thermal vapor to ablate prostate tissue in order to reduce prostate volume, thereby alleviating obstruction and symptoms associated with benign prostatic hyperplasia (BPH). It is suitable for male patients aged 50 years or older with a prostate volume (with or without hypertrophy of the central zone and/or middle lobe) of 30-80 cm due to benign prostatic hyperplasia.

This product provides a new treatment method for benign prostatic hyperplasia, which is more efficient and safer than traditional surgical treatment. The average operation time is only 5-8 minutes, and there is no severe sexual dysfunction after the operation.

In recent years, relying on the policy boost of the "Double Nine Articles," the pilot application of clinical real-world data in the Lecheng Pilot Zone has been proceeding at full speed, exploring reforms in China's review and approval systems and accelerating the registration and market entry of globally groundbreaking products in China.

Applied and Approved in 4 Months, Nearly 100 Patients Have Benefited

By taking advantage of the fast-track policies in Boao Lecheng, two products have achieved positive results in treating Chinese patients with benign prostatic hyperplasia (BPH). They were approved just four months after the registration application was submitted, and nearly a hundred BPH patients have already been treated using this innovative technology.

This simultaneous approval of two products marks an important milestone in the advancement of the real-world data application pilot program in Boao Lecheng, Hainan. It provides "Hainan experience" for accelerating the accessibility of global innovative drugs and medical devices in China and will attract more international advanced medical device manufacturers, pharmaceutical companies, and medical institutions to establish a presence in Lecheng.

Boston Scientific Greater China President Zhang Jun stated that Boston Scientific's innovative products have been approved for the first time through real-world studies. The "Lecheng Speed" has greatly inspired us. As the medical device company with the highest number of products selected for Lecheng’s real-world research, Boston Scientific will continue to collaborate with the Boao Lecheng Greater Health Ecosystem, sharing our global R&D achievements and clinical experience. We aim to support Lecheng Pilot Zone in exploring innovative review and approval models, accelerating Chinese patients' and doctors' access to world-leading medical resources.

A relevant official from the Lecheng Administration stated that, with the progress of Hainan's clinical real-world data application pilot program, Lecheng will promote benchmark projects such as the application of clinical real-world data to seize the "world's first" position.

Lecheng Pilot Zone actively explores the use of real-world clinical data for the registration and regulatory decision-making of pharmaceuticals and medical devices. It fully utilizes the excellent opportunity of large public hospitals such as Ruijin and Huaxi settling in Lecheng to provide new solutions for the reform of the drug and medical device review and approval system in China, and to accelerate the accessibility of global innovative products in clinical use within the country.