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经导管三尖瓣环成形系统获批上市

国家药品监督管理局批准了上海汇禾医疗科技股份有限公司的经导管三尖瓣环成形系统创新产品注册申请。该系统包括三尖瓣环夹系统和输送鞘套件,用于缓解患者的三尖瓣反流和心衰临床症状,适用于65岁以上不适合外科手术的高危禁忌患者。药品监督管理部门将加强上市后监管,保护患者用械安全。

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三尖瓣反流治疗新曙光:国产经导管系统获批上市 医药魔方
经导管三尖瓣环成形系统获批上市 医药魔方
中国首款经导管三尖瓣器械K-Clip获批上市 医谷网

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经导管三尖瓣环成形系统获批上市

国家药品监督管理局批准了上海汇禾医疗科技股份有限公司的经导管三尖瓣环成形系统创新产品注册申请。该系统包括三尖瓣环夹系统和输送鞘套件,用于缓解患者的三尖瓣反流和心衰临床症状,适用于65岁以上不适合外科手术的高危禁忌患者。药品监督管理部门将加强上市后监管,保护患者用械安全。

媒体报道
三尖瓣反流治疗新曙光:国产经导管系统获批上市 医药魔方
经导管三尖瓣环成形系统获批上市 医药魔方
中国首款经导管三尖瓣器械K-Clip获批上市 医谷网

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