健世科技-B(09877.HK):SimuLock成功完成首例確證性臨牀試驗植入手術
格隆匯11月13日丨健世科技-B(09877.HK)宣佈,公司全資子公司寧波迪創醫療科技有限公司("迪創醫療")開發的左心耳封堵器系統(SimuLock)的確證性臨牀試驗於近日入組首位患者,並在復旦大學附屬中山醫院成功完成首例植入。該確證性臨牀試驗的結果將被納入迪創醫療未來向國家藥品監督管理局提交的註冊申請。
SimuLock的仿生學錨定結構及可根據需求進行模塊化組裝的設計,可實現安全錨定,降低安全風險,可以覆蓋廣泛的左心耳解剖結構差異性巨大的房顫患者;採用立體式封堵及可控差異內皮化覆膜,顯著減少組織刺激,預防血栓栓塞。
董事會期待SimuLock早日完成臨牀研究,並將繼續發揮研發、臨牀及生產優勢,以期為越來越多的患者帶來安全、有效的產品。
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