藍帆醫療(002382.SZ):Biofreedom Ultra鈷鉻合金支架獲得CE證書
格隆匯 10 月 20日丨藍帆醫療(002382.SZ)公佈,公司於近日收到認證公告機構DEKRA Certification B.V.頒發的鈷鉻合金二代升級版冠脈支架BioFreedom™ Ultra的CE證書。
BioFreedom™Ultra是公司下屬子公司Biosensors International Group, Ltd. (“柏盛國際”)的新型(84μmβ) CoCr聚合物和無載體藥物塗層支架,採用了柏盛國際的專利Biolimus A9™藥物,親脂性達到普通藥物的10倍以上,能夠顯著抑制血管平滑肌細胞增生,有效降低經皮冠狀動脈介入治療術(PCI)後的再狹窄率。
Biofreedom™ Ultra進行了LEADERS FREE III試驗,證明二代Biofreedom的安全性和有效性更高於不鏽鋼藥物塗層支架和裸金屬支架。Biofreedom™ Ultra聚焦高出血風險患者的臨牀需求,可覆蓋的高出血風險患者的範圍廣、病情複雜,術後雙重抗血小板治療(DAPT)時間短,短期內可保持相對於其他公司產品在高出血風險患者中的領先優勢。
公司新一代鈷鉻合金冠脈支架BioFreedom™ Ultra取得CE證書表明該產品符合歐盟相關要求,已經具備歐盟市場的准入條件,可以在歐盟及相關海外市場銷售,其在歐洲上市將進一步增加公司的介入心血管產品組合,該產品與Biomatrix Alpha一道將促進歐洲市場收入提升,並通過升級產品保持公司現有的毛利率水平。Biofreedom™ Ultra將為臨牀醫生和患者提供新的治療選擇,有利於進一步提升公司的品牌效應,擴充公司海外銷售產品品類並加快公司開拓國際市場的步伐。
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