远大医药(00512.HK)获批中国市场首款双适应症创新冠脉介入治疗药物球囊产品医疗器械注册证
格隆汇10月14日丨远大医药(00512.HK)发布公告，由集团及位于德国的联营公司Cardionovum GmbH (“Cardionovum”)共同自主开发的中国市场首款同时具有支架内再狭窄( “ISR”) 和小血管病变(“SVD”)的双适应症的创新冠脉介入治疗产品“紫杉醇释放冠脉球囊扩张导管”(商品名：RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter)(为一款药物涂层球囊产品) (“RESTORE DEB”)，已于近日获批国家药品监督管理局颁发的“医疗器械注册证”，并将会由集团负责于中国的推广和销售。
RESTORE DEB为自研药物涂层球囊产品，采用独有的SAFEPAX专利涂层技术，可减少导管送达病变过程中，球囊表面药物被血液冲刷流失，提高药物到达靶病变部位的比率，同时减少冠脉血管远端微栓塞及痉挛风险，而且因为RESTORE DEB采用极小的紫杉醇药物粒径，可使病变目标获得更佳的组织吸收，发挥更持久的药物作用，从而提升临床有效性。
作为心血管权威专家期待的冠心病经皮冠状动脉介入治疗(PCI治疗)原创产品之一，RESTORE DEB获批后将成为目前中国市场首款及唯一一款具有支架内再狭窄和小血管病变的双适应症产品，拥有广阔的临床价值和市场前景。
公告表示，本次RESTORE DEB产品取得“医疗器械注册证”，代表集团具备于中国销售或分销该产品的资格，有望与集团在心血管领域的优势产生积极的协同作用。集团会充分发挥在心血管领域的资源优势，积极推动该创新产品的上市销售，同时籍以丰富集团的医疗器械产品种类，提高市场竞争力。
此外，集团另外两款创新自研药物涂层球囊产品Aperto及Legflow中国的临床研究和注册进程也在积极推进中，上市后将丰富集团在血管介入领域内的产品管线。集团将持续在医疗器械领域(特别是创新、原研的产品)积极拓展，为医生和患者提供更多的临床选择。
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