独家 | 心脏起搏器进口替代空间广阔

独家 | 心脏起搏器进口替代空间广阔

发布日期：2014-07-17

作者：闻宜

今年6月，乐普医疗总裁蒲忠杰透露：乐普医疗2010年收购的陕西秦明医学公司所研发的双腔起搏器明年5、6月将会上市。目前国内涉及心脏起搏器的手术一年有5～6万例，其中一半以上的产品是双腔起搏器，平均价格为5万元左右。当前国内植入式心脏起搏器市场被美敦力、圣犹达、百多力、波士顿科学4家外资企业所垄断。双腔起搏器适应症更广，国产品牌上市后将真正参与到国外品牌竞争当中，进口替代空间非常广阔。

治疗心脏节律失常最有效的方法

人工心脏起搏器是应用一定型式的起搏脉冲发生器，与特制的导线（即：起搏导管电极）连接，和起搏电极发送电脉冲刺激心脏，使激动不能或传导不好的心脏应激而起搏的医疗电子仪器。

1957年，全球第一台便携式体外心脏起搏器由美国人厄尔•巴肯发明。三年后，厄尔•巴肯和威尔森•格雷特巴奇制造出第一个可植入式心脏起搏系统。在2001年，他们获得了美国工程院颁发的美国工业界最高奖拉斯奖，同时获奖的另一个改变世界的发明是Internet（国际互联网），这两项发明都被评为20世纪最伟大的工程技术成就。目前心脏起搏器是治疗心脏节律失常最有效的方法。

 

图1：单腔起搏器

 

图2：双腔起搏器

我国植入心脏起搏器的人数比例偏低

目前市场上进口双腔心脏起搏器的医院平均销售单价为4万～5万元，而单腔起搏器平均价格也要2万元人民币左右，价格比较昂贵。由于经济因素和医疗保险覆盖等多种原因，我国每年植入心脏起搏器的人数比例是比较低的，只占整个应植入患者总数的一成左右，这一比例远远低于欧美等发达国家。

以美国为例，中国人口是美国的4倍多，心律失常的发病率跟美国基本一致。但美国每百万人口安装心脏起搏器的数量为近1000台，中国2011年只有36台，不到美国的1/30。

据统计，我国每年新增房颤病人或心衰病人约54万人，其中至少有一小半人需要安装心脏起搏器，但实际上安装心脏起搏器人数却大大的不足。

随着我国人民生活水平的提高和老龄化程度的加剧，未来对植入性心脏起搏器的需求也将逐渐增大。从近几年的数据来看，植入量呈现15%的稳定增长，预计到2020年前将保持这种增长趋势。

进口替代空间广阔

目前国内心脏起搏器的市场空间完全被国外产品垄断。上世80年代初期，美国圣犹达公司生产的心脏起搏器进入中国，随后德国百多力公司和美国美敦力公司也分别在80年代末期和90年代初进入中国市场。21世纪初期，美国波士顿科学也进入中国市场，逐渐形成四足鼎立的局面。

由于技术壁垒较高，国产心脏起搏器的研发进度缓慢。直到2009年，陕西秦明医学才推出单腔心脏起搏器。秦明医学通过与西安交通大学合作，开发出拥有自主知识产权的国产起搏器，并于当年取得了内资企业中目前唯一的国产心脏起搏器注册证。2010年，秦明医学被乐普医疗控股收购。据最新的消息，公司研发的双腔起搏器明年有望上市，正在研发的三腔起搏器也将进入临床试验阶段。另一家国内企业杭州能可爱心公司也主要从事心脏起搏器研发，但目前还没有产品面世。

在欧美发达国家，目前平均每只起搏器的价格在2000～2500美元之间（其中还包括植入手术费在内），而且许多欧洲国家植入起搏器可以报销全部或部分费用，故在发达国家心脏起搏器有很高的安装比例。随着我国国产的植入式心脏起搏器进入市场，同等档次的国产产品的价格则至少比进口产品低1/3，势必大大降低心脏起搏器的价格，很有可能重复心脏支架进口替代的路径。另外，现在医保对安装心脏起搏器的支持越来越大，报销比例已经由50%上升到60%甚至70%，在一些经济条件好的地区，甚至可以达到80%～90%，医保的覆盖逐步扩大，无疑为心脏起搏器市场爆发提供了充足的动力。

来源：医疗器械创新网

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