信立泰(002294.SZ):雷帕黴素藥物洗脱外周球囊導管完成醫療器械臨牀試驗備案
格隆匯 9 月 25日丨信立泰(002294.SZ)公佈,近日,公司在研產品“雷帕黴素藥物洗脱外周球囊導管”在臨牀試驗牽頭單位通過倫理會審查,並完成在廣東省藥品監督管理局的備案。
名稱:雷帕黴素藥物洗脱外周球囊導管;申請事項:醫療器械臨牀試驗備案;備案號:粵械臨備20200221;分類:境內III類,無源,非植入;臨牀用途:雷帕黴素藥物洗脱外周球囊導管適用於股動脈和膕動脈的經皮腔內血管成形術,用於擴張和治療狹窄或閉塞的血管病變。
雷帕黴素已被證實是安全且有效的細胞抑制作用藥物,其抗再狹窄能力和安全係數優於紫杉醇已在冠脈領域的雷帕黴素藥物支架得到了充分驗證;同時,相比較紫杉醇,其具有更高的安全性和更寬的治療區間,且具備抗炎效果。
雷帕黴素藥物洗脱球囊(DCB)近年來一直處於研發階段,其難點在於:雷帕黴素相對親水,很難噴塗在球囊表面並傳輸到病變區域,達到治療效果。該雷帕黴素藥物洗脱外周球囊導管在現有的塗層技術上實現突破,以全球獨創的“微型貯存池技術(Micro-reservoir)”和“細胞粘附技術(CAT™)”為基礎,可實現精確控制和持續性的藥物釋放,達到在組織細胞內的長期治療效果。其獨特的細胞粘附技術(CAT™)能促進更高的藥物轉移效率,從而降低球囊表面的藥物劑量。
目前,國內尚無雷帕黴素藥物球囊導管上市,隨着人口老齡化和城鎮化進程的加速,心腦血管疾病危險因素流行趨勢明顯,心血管疾病發病人數持續增加。雷帕黴素藥物洗脱球囊可用於治療冠脈疾病、外周動脈疾病等心血管疾病,產品市場前景廣闊。
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