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歸創通橋-B(02190.HK):國家藥監局批准大直徑PTA球囊擴張導管在中國上市
格隆匯 04-12 21:27

格隆匯4月12日丨歸創通橋-B(02190.HK)發佈公吿,公司於2022年4月12日欣然宣佈,公司自主研發的用於外周血管系統的經皮腔內血管成形術(PTA)的大直徑PTA球囊擴張導管已按計劃獲得中國國家藥品監督管理局的上市批准。這是國內首個獲得國家藥監局批准的國產研發的大直徑PTA球囊擴張導管產品,也是公司2022年從國家藥監局獲得的第二個批准。

該產品是在我們的球囊成型和製造平台上研發和製造的,在該平台上,公司以始終如一的高質量和高效率生產了公司所有的球囊擴張導管產品。該產品有很多顯着的特點:(1)獨特的錐形頭端和短肩設計,即使對於迂曲的病變也能最大限度地保護正常血管;(2)編織輸送杆表現出出色的通過性能;(3)出色的顯影性可確保在手術過程中準確定位球囊。

此外,該產品有望提供優秀的充盈性能,並且有多種規格,可滿足不同臨牀需求。公司預計該新推出的產品在治療多種血管疾病方面顯示出優勢,例如髂靜脈受壓綜合症和其他外周血管阻塞。當本產品與機械血栓清除裝置、藥物塗層球囊和外周支架適當配合使用時,公司期望看到更好的長期治療效果。

該產品的成功推出,使公司成為國內首家能夠提供包括Ultrafree?藥物洗脱PTA球囊擴張導管、外周PTA球囊擴張導管和高壓PTA球囊擴張導管在內的全方位外周球囊擴張導管產品的公司,涵蓋動脈和靜脈疾病治療領域。公司相信,隨着這款產品的推出,公司能夠更好地解決國內患者尚未得到滿足的臨牀需求。

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