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乐普医疗(300003.SZ)血管内药物(紫杉醇)洗脱球囊导管(冠脉)获得CFDA注册申请受理
格隆汇 06-05 17:01

格隆汇6月5日丨乐普医疗(300003.SZ)公布,公司自主研发的血管内药物(紫杉醇)洗脱球囊导管(冠脉),于2019年6月5日获得国家药品监督管理局下发的《受理通知书》。该产品是公司继可降解支架上市后,在推进心血管介入无植入时代进程的又一重磅产品。

心血管介入治疗正走向介入无植入时代。实现介入无植入的核心治疗产品主要包括可降解支架和药物洗脱球囊。介入无植入是广大心血管病患者追求的理想目标,是介入治疗领域的最高境界,也是生产企业技术迭代创新的追求目标。心血管介入技术由球囊导管扩张、金属裸支架植入、金属药物支架植入,通过近40年技术逐渐迭代演变为可降解支架植入和药物球囊导管扩张,标志着心血管介入治疗进入介入无植入时代。乐普医疗将进一步加大研发投入,为介入无植入目标的实现,提供满足各种适应症需求的介入无植入治疗产品,同时研发实现介入无植入的各种辅助导管和腔内检验导管及器械,满足患者不同适应症不同疾病的治疗需求。

公司药物洗脱球囊注册申请受理后,须经国家药品监督管理局审批。

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