先健科技(01302.HK)新一代腹主動脈覆膜支架系統獲批上市
2021年11月24 日，先健科技公司(01302.HK)宣佈，自主研發的Yuranos™腹主動脈覆膜支架系統(以下簡稱“Yuranos™”或“該產品”)獲國家藥品監督管理局(NMPA)註冊批准。該產品用於腎下型腹主動脈瘤的腔內治療，將為廣大腹主動脈瘤患者，尤其是複雜瘤體形態的患者提供更優的器械解決方案。
腹主動脈瘤(AAA)指腹主動脈呈瘤樣擴張，通常以直徑增大50%以上定義為動脈瘤。隨着人口老齡化發展、多種影像檢查的應用及臨牀認識水平的不斷提高，我國腹主動脈瘤的檢出率逐年升高。腹主動脈瘤腔內修復術(EVAR)因其具備創傷小、術中出血量少、術後恢復快等優勢從而發展迅速，現已成為治療腹主動脈瘤的主流方式[1]。然而傳統的腔內修復技術對主動脈瘤的解剖形態有較高的要求，對於解剖形態比較複雜的腹主動脈瘤，如成角嚴重、瘤頸較短等情況，傳統的腔內修復技術尚無法有效進行干預。據統計，不適用傳統腔內修復技術的複雜形態的腹主動脈瘤在已被發現的腹主動脈瘤中約佔25-40%。[2]
針對龐大的臨牀治療需求，先健科技Yuranos™腹主動脈覆膜支架系統應運而生。其在首代產品的基礎上進一步優化了產品設計，使其相較於同類型產品，能夠適用於臨牀中更為複雜和更為挑戰的瘤體解剖形態，即其可滿足腹主動脈瘤近端最小瘤頸長度10mm和最大腎下成角75°的複雜情況。先健科技Yuranos™的問世，將進一步推動EVAR治療適應證的拓展。同時，該創新產品帶來的技術升級，有效提升了EVAR治療的術中和遠期效果，並顯著降低了手術併發症的發生風險。
Yuranos™腹主動脈覆膜支架系統採用分體式設計，由腹主動脈分叉支架、髂動脈延長支架及其對應的輸送器組成，兩者配套使用，手術時分別由輸送器輸送和釋放到預定位置。其中，腹主動脈分叉支架主體覆膜近端裸段倒刺和獨特的閉環mini支撐波設計，極大地提高了支架整體的錨定性、貼壁性及柔順性，能夠有效防止移位和I型內漏。髂動脈延長支架的錨定倒刺設計，增強了其與腹主動脈分叉支架之間的連接強度，可有效防止支架脱落導致的III型內漏。此外，輸送器後釋放功能配合支架組件的錨定設計，可實現更為精準的支架定位和術中調控，進一步提升了該器械的操作性能和即刻手術成功率。其註冊臨牀研究結果顯示，手術成功率為100%，術後12個月腹主動脈瘤治療成功率優於行業平均水平，術後12個月隨訪未發生重大器械相關不良事件，為廣大患者帶來了全新的、安全有效的治療方案。
先健科技Yuranos™腹主動脈覆膜支架系統獲批上市，標誌着其在主動脈腔內治療產品的創新與精進上再次向前邁出重大步伐，進一步優化了其在全腔內介入治療領域的產品佈局。未來，先健科技將繼續堅持創新引領，攜手業內專家推進更多臨牀急需器械產品的研發和上市，造福廣大患者。
參考文獻：
[1] Chaikof EL, Dalman RL, Eskandari MK, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm[J]. J Vasc Surg, 2018,67(1):2-77.e2. DOI: 10.1016/j.jvs.2017.10.044.
[2] 短瘤頸腹主動脈瘤腔內治療進展,365醫學網,2018.1.16
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