FDA批准**无导线起搏器治疗心律失常

2016-04-08 Mechront 译 MedSci原创

美国美敦力公司称,该公司开发的一款长约1英寸的植入右心室的无导线起搏器(Micra Transcatheter Pacing System, Medtronic)已经通过美国食品药品监督管理局的批准,用于心律失常的治疗。FDA指出,Micra适用于心房颤动或心搏徐缓-心搏过速综合征等心搏不规律患者。但是对于已有植入设备且会影响起搏器或严重肥胖或者静脉无法容纳7.8 mm导引鞘或植入心脏起搏器的患者

美国美敦力公司称,该公司开发的一款长约1英寸的植入右心室的无导线起搏器(Micra Transcatheter Pacing System, Medtronic)已经通过美国食品药品监督管理局的批准,用于心律失常的治疗。

FDA指出,Micra适用于心房颤动或心律徐缓/心搏过速综合征等心搏不规律患者。但是对于已有植入设备且会影响起搏器或严重肥胖或者静脉无法容纳7.8 mm导引鞘或植入心脏起搏器的患者,该装置是不适合的。

FDA设备和放射卫生中心设备评估办公室代理主任William Maisel说:“Micra作为第一款无导线起搏器,为患者的治疗提供了新选择,并且避免了导线相关健康问题。”

NEJM上关于Micra的全球临床试验数据显示,725名植入该装置的患者中约有98%的患者在6个月后,其心搏恢复正常;只有不到7%的患者出现了并发症,包括住院时间延长、深静脉血栓、肺栓塞、心脏损伤、装置错位和心肌梗死

研究的主要作者、俄克拉何马大学健康科学中心心血管主任Dwight Reynolds教授说:“研究结果表明,Micra这种小型化的设备,使用微创新技术,可以给患者带来最先进的起搏技术,具有显著的安全性和有效性,无疑给我们带来了很大信心。”


附Micra微型无线起搏器:



Micra的大小不超过一枚欧元硬币(或镍币),是传统起搏器的1/10大小;该装置通过导管置入体内,不需要通过传统外科手术做一个“口袋”。

原始出处:

FDA approves leadless pacemaker to treat arrhythmia disorders.Healio.April 6, 2016

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    2016-06-21 bugit
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    2016-04-14 李继凯

    文章不错

    0

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    2016-04-14 李继凯

    值得关注

    0

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    2016-04-09 HNYYM
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    2016-04-08 1de3b290m83(暂无匿称)

    期待

    0

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    2016-04-08 午夜星河

    厉害

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    2016-04-08 1de7460am01(暂无匿称)

    最值得期待!于病人、医生、厂家均有益。

    0

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