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沪产优质“中国心” 打破国外技术垄断

2017-09-06 08:21:44   中国青年网

本报讯(记者 陈玺撼)历经两年多的精心打磨和严格审批,上海制造的国内首批具有国际先进水准的国产植入式心脏起搏器,近日正式获得国家食药监总局的批准,有望彻底改变心脏起搏器被进口产品垄断的局面,实现中国人造“中国心”的梦想。

这批“中国心”由位于上海张江的创领心律管理医疗器械(上海)有限公司(以下简称“创领心律医疗”)生产,共有三个系列八个型号。

之所以具有国际先进水准,主要体现在体积和寿命等方面。在体积上,借助自身独创研发设计的电极系统,整个心脏起搏器的体积缩小到8立方厘米,比国际市场流行的10立方厘米还要小,植入对病人的影响更小。在寿命上,这批心脏起搏器采用了国际一流的原材料,最长使用寿命可达10年至12年,向国际一线品牌看齐,可以满足不同病人的需要。

创新绝非一蹴而就。创领心律医疗由上海微创医疗器械(集团)有限公司以51%的股权控股,与意大利索林集团于2014年合资成立。为了“中国心”,双方合作攻关多年,拥有多项相关国际专利。2015年6月,中国第一条与国际先进水准接轨的国产心脏起搏器生产线在该公司落成,初步规划年产能在五万只以上,使上海具备了生产国际一流心脏起搏器的能力。此后,创领心律医疗开发的心脏起搏器申请作为创新医疗器械,被纳入国家食药监管总局的“创新医疗器械特别审批程序”,从而加速了注册审批的速度和面世的时间。

数据显示,国内有约100万名心动过缓患者,年新增病例约30万到40万例,但目前年均只有约8万名患者植入了心脏起搏器,这其中绝大多数都是“外国心”。据业内人士介绍,普通的进口心脏起搏器售价约在五六万元,寿命在8年左右,到期须更换。

创领心律医疗首席执行官王励表示,“中国心”获批上市后,将用国际品质、国内价格,打破“外国心”高价垄断市场的局面,惠及更多病患。业内人士指出,国产心脏起搏器进入市场后,将促使该领域相关医疗器械的价格下降约三成。

另据透露,创领心律医疗自主研发的起搏导线、起搏系统分析仪等产品均已进入临床试验阶段,将力争尽早上市,为“中国心”配套更多国产产品。

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