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欧盟CE认证 圣犹达新型心脏再同步化治疗起搏器获CE 认证 中鸿认证咨询 发布时间: 2015-02-24 17:38 点击:

欧盟CE认证 圣犹达新型心脏再同步化治疗起搏器获CE 认证 中鸿认证咨询
The European Union CE certification St. Jude Medical Model of cardiac resynchronization therapy pacemaker certified by CE certification consulting in Hong
近日,圣犹达医疗宣布旗下一款新型的用于治疗心衰患者的心脏再同步化治疗(CRT)起搏器获得 CE 认证。“CE”标志是一种安全认证标志,被视为制造商打开并进入欧洲市场的护照。
Recently, St. Jude Medical announced that a model for the treatment of heart failure in patients with cardiac resynchronization therapy (CRT) pacemaker to obtain CE certification. "CE" mark is a kind of safety certification, manufacturers as open and enter the European market.
根据发布会的介绍,这款名为 Quadra Allure MP 的 CRT 起搏器主要配合左室电极四件套和圣犹达医疗的多点起搏技术共同使用。
According to the briefing introduction, called the Quadra Allure MP CRT mainly with left ventricular pacemaker electrode four piece suit and St. Jude Medical multipoint pacing techniques in common use.
这将允许医生能够设定在每个起搏周期内对不同部位发送两个脉冲信号。圣犹达表示将为医生提供更多的起搏选择和随访干预程序,并将降低对治疗无反应的比例
This will allow doctors to set at each pacing cycle in different parts of the two pulse signal transmission. St. Jude offered pacing selection and follow-up intervention program more doctors, and will reduce the proportion of non response to therapy
在 2014 年罗马举办的国际临床起搏进展研讨会上,对该设备的研究显示,与传统的 CRT 相比,新型的 CRT 配合多点起搏技术可使 12 个月的治疗反应率增加 19%。
Progress in international clinical pacing held in 2014 the Rome seminar, research on the device display, compared with the traditional CRT, model CRT with multisite pacing technology can make the response to therapy 12 month rate increases 19%.
此外,在既往对 CRT 有反应的患者中,新型的 CRT 还可以提高左室射血分数。
In addition, in the previous response to CRT patients, new CRT also can improve the left ventricular ejection fraction.
来自意大利圣玛丽亚德拉慈悲医院的 Francesco Zanon 在发布会上表示:“根据我们最初的经验,我们认为多点起搏技术可以更好地再同步化,并且也是 CRT 进一步的优势。传统 CRT 起搏可明显改善心功能,由于这种技术可以用于所有的 CRT 设备,我们相信它会得到广泛应用”。
From Italy Santa Maria della Mercy Hospital Francesco Zanon said at the press conference: "according to our initial experience, we think the multisite pacing technology can better synchronization, and also the CRT further advantages. The traditional CRT pacing can improve cardiac function, since this technique can be used for all CRT devices, we believe it would be widely used".
欧盟CE认证圣犹达新型心脏再同步化治疗起搏器获CE 认证 中鸿认证咨询
The European Union CE certification St. Jude Medical Model of cardiac resynchronization therapy pacemaker certified by CE certification consulting in Hong