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ValveClamp: 一种最易操作的经导管二尖瓣修复系统


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ValveClamp: 一种最易操作的经导管二尖瓣修复系统

ValveClamp技术原理与MitraClip相同,是根据外科缘对缘缝合技术设计的。ValveClamp植入时无需传统外科开刀,经外周动脉(或心尖)植入,可用于无法外科手术老年的以及不愿意外科开刀年轻的二尖瓣反流患者。相对MitraClipValveClamp有输送系统型号更小(14FMitraClip 24F)、操作更简单、尺寸更多样、生产成本更低等优点。值得注意的是,该产品可能是目前世界上最容易操作的经导管二尖瓣修复器械,平均导管操作时间为36分钟,明显短于MitraClip(157分钟)Mitralign124分钟)、Cardioband186分钟)及Neochord120分钟)等几个国际上最成熟的二尖瓣修复器械。该产品已获得中国国家专利授权,同时也申请了国际PCT专利。该产品已获得系列动物实验成功,拟明年进行临床试验。

ValveClamp:  the easiest-operating transcatheter mitral valve repair system 

The principle of ValveClamp is the same as that of MitraClip, which is based on the surgical edge-to-edge suture technique. ValveClamp can be implanted through peripheral artery or apex, without the need of traditional open-heart surgery. It may be used for elderly patients with mitral regurgitation in contradiction to surgery. Compared with MitraClip, the profile of delivery system of ValveClamp is much smaller (14F, versus 24F for MitraClip), the operation is easier,the size is more varied and the production cost is lower. It is notable that ValveClamp may be the easiest-operating transcatheter mitral valve repair system in the world. The average catheter operating time of ValveClamp is 36 minutes, much shorter than that of the several most mature transcatheter mitral valve repair devices, including MitraClip (157 minutes), Mitralign (124 min), Cardioband (186 min) and Neochord (120min). ValveClamp has obtained a China national invention patent and the international PCT patent is being applied. ValveClamp has been successfully tested in a series of animal experiments and will enter clinical trial in the next year.

 

1 MitraClipValveClamp的对比


MitraClip

ValveClamp

依据原理

外科缘对缘缝合手术

外科缘对缘缝合手术

实施方式

用夹子捕获两个瓣叶后夹合

用夹子捕获两个瓣叶后夹合

材料

钴铬合金、聚氨酯

镍钛合金、PEEK、不锈钢

夹子型号

只有一种型号(臂8*4mm)、适用病人范围较窄

3 种型号,适用多种病人解剖

路入途径

 股静脉-房间隔

外周动脉或心尖

输送系统(伤口)大小

24F8mm

14-16F4.7-5.3mm

路径及操作难度

路径长而曲折,故操作难

路径短而直,故操作简单

捕获范围及操作难度

范围较有限,故操作难

范围更广,故操作更简单

国内价格

25万人民币(加税)

10万人民币左右

 

 

2  ValveClamp和目前国际上最成熟的二尖瓣修复器械手术操作时间对比


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