信立泰(002294.SZ)：雷帕黴素藥物洗脱椎動脈支架系統獲醫療器械註冊證
格隆匯 7 月 23日丨信立泰(002294.SZ)公佈，近日，公司子公司雅倫生物科技(北京)有限公司收到國家藥品監督管理局核准簽發的“雷帕黴素藥物洗脱椎動脈支架系統”(Maurora®)《醫療器械註冊證》。
產品名稱：雷帕黴素藥物洗脱椎動脈支架系統；結構及組成：該產品由藥物塗層支架和輸送系統組成，其中支架材料選用鈷鉻合金L605，藥物塗層由載有雷帕黴素(西羅莫司)的聚偏氟乙烯六氟丙烯共聚物載體及聚丙烯酸酯底塗層組成，藥物密度8.5±2.1μg/mm。輸送系統由導管座、應力擴散管、球囊組成。支架安裝在球囊上。產品經環氧乙烷滅菌，一次性使用。產品貨架有效期2年。適用範圍：適用於症狀性椎動脈顱外段狹窄的擴張。註冊證編號：國械注準20203130645。
Maurora®雷帕黴素藥物洗脱椎動脈支架系統是一款同時經過顱內動脈(大腦中動脈和椎-基底動脈)和椎動脈(包括椎動脈開口)嚴謹臨牀驗證的雷帕黴素藥物洗脱椎動脈支架系統，適用於症狀性椎動脈顱外段狹窄的擴張。其在顱內動脈狹窄治療與對照組對比數據優效趨勢明顯；在椎動脈顱外段與對照組相比優效結果成立。
同時，在研究和驗證過程中，Maurora®支架經過了動物顱內動脈為模型多倍藥量雷帕黴素的動物實驗驗證，經過多組別、多時間點的觀察，腦組織相關部位均未發生藥物相關病理改變，充分證明本品在神經毒性方面的安全性。
Maurora®雷帕黴素藥物洗脱椎動脈支架系統是全球唯一一款雷帕黴素載藥椎動脈支架，首次將雷帕黴素應用於腦部血管狹窄治療，其特有的高生物相容性塗層，保證了藥物的穩定釋放，避免不良反應的發生。與目前市面上的裸金屬支架相比，其在抑制血管支架植入術後再狹窄發生的效果明顯，能防止因再狹窄導致的卒中復發，降低患者二次介入的風險，改善患者預後，提高患者生活質量。
雷帕黴素藥物洗脱椎動脈支架系統的上市，將進一步豐富公司心腦血管領域的器械產品線，並與公司的抗血小板藥品形成藥械協同，對公司今後的業績提升和長遠發展產生積極的影響。但具體銷售情況將受市場環境變化等因素的影響，存在一定的不確定性。敬請廣大投資者理性投資，注意風險。
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