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藍帆醫療(002382.SZ):BioFreedom支架、RISE NC球囊擴張導管獲批上市
格隆匯 06-24 16:00

格隆匯6月24日丨藍帆醫療(002382.SZ)宣佈,公司旗下的柏盛歐洲有限公司(Biosensors Europe SA)生產的BioFreedom支架和RISE™ NC球囊擴張導管於近日收到國家藥品監督管理局批准的醫療器械註冊證。

BioFreedom是公司下屬子公司Biosensors Europe SA(簡稱“柏盛歐洲”)研製的全球第一款無聚合物藥物塗層支架,以全球獨家專利的選擇性微孔結構表面(Selectively Micro-Structured Surface,簡稱“SMS”)無塗層技術與高親脂性專利BA9TM藥物的結合,特別適用於高出血風險患者,可以將支架手術後的雙聯抗血小板(簡稱“DAPT”)的治療期從6-12個月降至1個月,大幅提升了高出血風險患者經皮冠狀動脈介入治療(簡稱“PCI”)的有效性及安全性。

BioFreedom是全球首個被臨牀試驗驗證並寫入歐洲心血管治療指南中專門針對高出血風險患者的推薦支架。以BioFreedom支架為實驗組的LEADERS FREE的試驗,是世界上首次證明藥物支架可以應用於高出血風險患者,既能獲得冠脈藥物洗脱支架優於裸金屬支架的術後療效,也能達到裸金屬支架的長期安全性。後期在美國進行的LEADERS FREE II試驗再次驗證了BioFreedom支架在僅進行一個月DAPT治療的高風險出血患者人羣中,具有優異的安全性和更好的療效。

RISE™ NC球囊擴張導管是柏盛歐洲2019年在歐洲市場上市的新一代高壓塑形後擴球囊。小通過外徑、優化推送杆的設計,提高了球囊的整體推送性、通過性和追蹤性,具有快速精準定位、強大的非順應性塑形能力,能夠協助臨牀醫生完成最具挑戰的複雜病變。

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