MicroPort Neurotech today announced that it has received marketing approval issued by the Ministry of Health, Labour and Welfare of Japan for its independently developed Numen coil embolisation system—marking the first approved product in Japan for the company.
Numen 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 neurointerventional product, it has been approved by the Japanese authority for its “highly innovative clinical design and excellent performance”, according to MicroPort NeuroTech.
As a new generation of electronically detachable coils, Numen devices are made of thin and soft platinum–tungsten alloy wires, which are deployed through a microcatheter when placed in the aneurysm sac.
The company claims that it permits stable framing, and 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 embolisation options” to ensure safety and efficacy in all stages of the coiling procedure, MicroPort NeuroTech also says.
The Numen coil embolisation system and NumenFR coil detachment system were approved for marketing in China in 2020, before their first overseas implantations in August 2021. They have further received CE-mark certification in the EU, marketing approval from US Food and Drug Administration (FDA), and regulatory clearances in South Korea and Brazil.
MicroPort NeuroTech recently announced that its Numen system had been successfully used in the first two implantations in Poland, with the device’s pushability and detachability being “highly appreciated” by the physicians involved.
Earlier this month, the company also announced that its independently developed Apollo intracranial arterial stent system had been implanted in a patient in Brazil, marking its first application in the country as well as in any overseas market outside China.