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MicroPort NeuroTech™ NUMEN Coil Embolization System Receives Marketing Approval in Japan

发布时间: 2022-08-27 10:00:00

Tokyo, Japan, 22 August 2022 – MicroPort Neurotech Limited (“MicroPort NeuroTech™”), a pioneering Chinese company in the field of neurovascular interventional treatment, today announced that it has received marketing approval issued by Ministry of Health, Labour and Welfare Japan for its independently-developed NUMEN™ Coil Embolization System (“NUMEN™”), marking the first approved product in Japan for MicroPort NeuroTech™.

 

Globally, Japan is the third largest market for neuro-intervention. NUMEN™ Coil Embolization System is classified as a Category IV high-risk medical device with special control, and experience-demanding requirements during the registration process. As a self-developed, designed and manufactured neuro-interventional product, NUMEN™ has been approved by the Japanese authority for its highly innovative clinical design and excellent performance.

 

According to World Health Organization, stoke is the second leading cause of death. The possibility of aneurysm rupture increases over time, and intracranial aneurysms are known as “time bomb in the head” due to its high mortality and morbidity rate upon rupture. As a new generation of electronically detachable coils, NUMEN™ are made of thin and soft platinum–tungsten alloy wires, which are deployed through a microcatheter when placed in the aneurysm sac. It permits stable framing, smooth filling and finishing, with superb conformability to shapes of aneurysms. Its specifications with different diameters, lengths and softness levels, provides physicians with a full range of embolization options to ensure the safety and efficacy in all stages of the coiling procedure.

 

The NUMEN™ Coil Embolization System and NUMEN™ Coil Detachment System (“NumenFR™”) were approved for marketing in China in 2020. They have received EU CE Marking and marketing approval from US FDA, Korea MFDS, and Brazil ANVISA. Since their first overseas implantations in August 2021, NUMEN™ and NumenFR™ have been successfully commercialized in several markets in the Asia-Pacific region, North America and Europe, and have been fully recognized by physicians for stable and satisfying clinical performance.

 

The approval of NUMEN™ in the Japanese market represents yet another milestone in the globalization strategy for emerging markets. In the future, MicroPort NeuroTech™ will continue to strengthen in-depth cooperation with overseas clinical experts and provide top-quality and more accessible and comprehensive medical solutions to stroke patients worldwide.



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