Shanghai, China, 08 August 2023 — The research results of the NUMEN™ Coil Embolization System (NUMEN™) developed by MicroPort NeuroTech (Shanghai) Co., Ltd.（MicroPort NeuroTech™）, applied to small intracranial aneurysms, have been officially published in the Journal, BMC Surgery.
The CATCH clinical trial was a prospective, multicenter, randomized controlled clinical study conducted in China to investigate the efficacy and safety of coil embolism treatment for intracranial aneurysms. The trial adhered to international standards and was led by Professor Jianmin Liu from the Cerebrovascular Disease Center of Shanghai Changhai Hospital in collaboration with nine renowned neuro-interventional centers across the country.
Professor Sheng Guan's team from the First Affiliated Hospital of Zhengzhou University led the subgroup analysis of the "Application of NUMEN™ in <5mm Small intracranial aneurysms" in the CATCH clinical trial. A total of 124 patients were enrolled in the study. Overall, 58 patients were assigned to the NUMEN™ group, and 66 were assigned to the Axium group. The complete occlusion rate of intracranial aneurysms at the 12-month follow-up was 65.5% (38/54) in the MicroPort NeuroTech™ group and 66.7% (44/64) in the control group. There was no statistical significance between the two groups. The results of the CATCH study have validated the safety and efficacy of NUMEN™ for <5mm intracranial aneurysms. Its clinical effect was comparable to top-line products and reached an advanced global standard.
According to Professor Sheng Guan, "Not only should domestic neuro-interventional devices be on par with international standards in terms of design, technology, and actual results, but all aspects, including preclinical and clinical research phases, should also be summarized scientifically and strive for SCI publication to fully align with global neuro-interventional standards. It's gratifying to observe the efforts of the relevant R&D and application personnel of the NUMEN™ project and their outstanding achievements. I hope more domestic enterprises and products will reach the international stage."
Intracranial aneurysms, usually abnormal bulges occurring on the walls of intracranial arteries, show an increased risk of rupture over time. Once ruptured, the mortality and disability rates are extremely high. Consequently, they are called ‘time bombs’ in the skull. Aneurysms with diameters of <5mm are particularly difficult to treat due to their thin and fragile walls, regardless of whether the aneurysm has ruptured. NUMEN™, as a new generation of electrolytic detachment coil, is mainly used in the neuro-interventional treatment of intracranial aneurysms. Its ultra-fine platinum-tungsten wire material and unique three-dimensional structure combine softness with support, significantly reducing the pressure on the aneurysm wall and ensuring the safety of embolization. NUMEN™ is available in 177 different lengths and models, allowing doctors to choose the most appropriate model for precise filling based on different cases.
Since its approval in China in September 2020, NUMEN™ has successively obtained marketing approvals in six overseas countries and regions, including the European Union's CE certification, America’s FDA, Korea's MFDS, Japan's PMDA, Brazil's ANVISA, and Argentina's ANMAT. Clinical implants have been achieved in 11 countries and regions in Asia Pacific, North America, and Europe, all of which have received high praise from local clinical doctor teams.
About MicroPort NeuroTech™
Founded in Shanghai in 2012, MicroPort NeuroTech Limited (“MicroPort NeuroTech™”, stock code: 02172.HK), a subsidiary of MicroPort Scientific Corporation (“MicroPort®”, stock code: 00853.HK), is a pioneer and largest Chinese company in the neuro-interventional medical device industry in China, dedicated to providing innovative solutions for physicians and patients. MicroPort NeuroTech™ has gradually entered the top 10 countries and regions for the number of neuro-interventional surgeries, including the United States, Europe, South Korea, and Brazil. In the future, MicroPort NeuroTech™ will invest more resources in innovation and development to provide more high-quality and innovative cerebrovascular and neuro-interventional solutions for physicians and patients.
More information is available at: www.medneurotech.com