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先健科技(01302.HK):Yuranos™腹主动脉覆膜支架系统获得中国国药监局的注册批准

First Health Technology (01302.HK): Yuranos abdominal aorta covered stent system is registered and approved by the State Drug Administration of China.

格隆滙 ·  Nov 24, 2021 18:26

Gelonghui, November 24 (01302.HK) announced that on November 23, 2021, the Yuranos independently developed by the groupAbdominal aorta covered stent system "Yuranos""Or "the device") has been registered and approved by the State Drug Administration of China.

YuranosIt is used for the treatment of infrarenal abdominal aortic aneurysm. Compared with the same type of products, it is suitable for more complex clinical morphology, can meet the more extreme clinical anatomical structure, and has a wider range of indications: the minimum neck length of abdominal aortic aneurysm is 10mm, and the maximum infrarenal angle is 75 °. The instrument is a split design, including abdominal aortic bifurcation stent system and iliac artery extension stent system. Each system consists of a stent and a conveyor. The stent is composed of a nickel-titanium skeleton and a PET film. Each stent is loaded in its own conveyor, which is transported and released to the predetermined position during the operation. At the same time, the instrument has a unique design, which can effectively improve the effect of intraoperative and long-term treatment, and reduce the risk of surgical complications: I) the design of barbed proximal segment of abdominal aortic bifurcation stent and closed-loop mini support wave design, increase stent Anchorage, adhesion and flexibility, and effectively prevent displacement and type I internal leakage. Ii) iliac artery extension stent inverted stab design, enhance the connection between components, effectively prevent type III internal leakage caused by components falling off; iii) conveyor post-release function with stent assembly anchoring design to achieve accurate positioning and regulation, and further improve the availability of instruments and the success rate of immediate operation.

The Group will continue to adhere to independent innovation and join hands with industry experts to promote the R & D and listing process of innovative medical device products for the benefit of the majority of patients.

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