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国产高品质心脏起搏器获CFDA批准 心动过缓患者获福音
2017-09-11 07:36:37 中国经济网
经济日报讯 记者沈则瑾报道:近日,创领?心律管理医疗器械(上海)有限公司(简称“创领?心律医疗”)生产的RegaTM心系列植入式心脏起搏器正式获得国家食药监总局(CFDA)批准,成为国内首个具有国际先进品质的国产心脏起搏器,将惠及更多中国患者。
植入心脏起搏器是目前唯一能有效降低死亡率、提高患者生活质量的心动过缓治疗方法。据悉,国内约有100万心动过缓患者,并以每年约30万至40万新增病例的速度增加。然而,由于没有完全掌握起搏器的核心技术和缺乏产业化经验,我国的心脏起搏器几乎完全依赖进口,加之价格高昂,每年仅有约8万患者接受了起搏治疗。
为此,创领?心律医疗不断探索和推动“中国制造”+“中国创造”之路。此次获批的RegaTM心系列起搏器,严格遵循生产链相关要求,经20多道严苛检测达标,其功能和质量完全达到国际先进水平。
“我们的心系列起搏器具有自动化、生理性、小体积的国际化功能和长寿命特点。它们体积仅为8立方厘米,使用寿命可达10至12年,上市后可以满足不同病人的需要。”创领?心律医疗CEO、国家“千人计划”特聘专家王励博士说,创领心系列起搏器有多款型号可以满足不同患者的治疗需求,每个型号比同档次进口品牌心脏起搏器便宜20%至30%。“我们期待心系列起搏器以国际品质、国内价格,为中国临床医生救治更多患者提供安全、有效且更具性价比的高端产品和全程优质服务”。
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