最新消息 新型可穿戴人工肾获重大突破！

AWAKsorbent technology is a platform technology which is revolutionising both peritoneal dialysis and hemodialysis. Our technology in enabling development of ultra-portable PD and HD machines.

AWAK是世界首个可穿戴、便携式的新型腹膜透析装置，已经成功的在新加坡中央医院进行了人体试验。

1月11日，美国食品药品监督管理局（FDA）宣布：可穿戴式人工肾获得重大突破。

这个新的人工肾设备体积小巧、重量不到2公斤，能够给患者随身携带，随意走动，进行实时透析，克服了目前终末期肾病患者不得不长时间连接在大型透析机的挑战。

医学上，把慢性肾脏病分为5个阶段，尿毒症是各类肾病发展到最严重的第5阶段，此时人的肾功能所剩无几，不能继续为身体排出废物和毒素，就需要透析或者是肾移植来替代原有的肾脏工作。

某患者在家进行腹膜透析

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血液透析去透析中心由医护人员操作，每周去三次，一次4小时。

患者在透析中心进行血液透析

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传统透析方式虽然能挽救尿毒症患者生命，但还是让很多肾友感到工作、生活受到较大的约束。

有没有更轻便、更人性化的人工肾装置，不需要让人花费多少精力呢？

这是患者们的需求，也是研究的动力和方向。AWAK科技公司在这样的背景下研发了这款可穿戴式人工肾设备，并且已经成功的进行了人体试验。

WHAT IS ASORBENT?

Sorbent is a material that binds another substance or compound to it by a physical and/or chemical reaction. It allows the binding of an extremely thin layer of molecules to its surface by chemical bonds, ionic bonds and complexion.

什么是吸附剂？

吸附剂是一种通过物理和/或化学反应将另一种物质或化合物与之结合的材料。它允许通过化学键、离子键和肤色将极薄层分子结合到其表面。

该设备内部使用了新研发的吸附技术

Sorbent technology regenerates and reconstitutes used dialysis fluid into fresh fluid. This unique feature eliminates the current dependence on large volumes of dialysate and continuous water supply and costly water treatment in the case of HD.

Our patented sorbent technology removes the uremic toxins from the spent dialysate and regenerates fresh dialysate in real-time.

吸附剂技术将用过的透析液再生并重组为新鲜液体。这一独特的功能消除了目前对大量透析液和连续供水的依赖，以及高清情况下昂贵的水处理。

我们获得专利的吸附剂技术可以去除用过的透析液中的尿毒症毒素，并实时再生新鲜的透析液。

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团队成员，

该公司总部位于新加坡

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这项人体实验共招募15名尿毒症患者，这15人均成功完成连续3天使用该新型可穿戴腹膜透析装置，实验结果显示该设备能够有效替代肾脏排泄废物和毒素，并且没有任何人出现严重不良反应。

FDA给予了这项新技术高度认可。能够获得FDA授权突破性设备，意味着会加快这类设备的开发和审查。根据FDA的规定，要想授权突破性设备，必须是挽救人类危重疾病的重大突破。要么之前没有FDA批准的替代疗法可用，要么该技术必须比现有所批准的替代疗法具有显著优势。

这也意味着，终末期肾衰竭的肾友，离能用上新型的人工肾越来越近了！

可以预想，也许不用等太久，尿毒症患者日常生活只需要携带这么一个小小的设备就能替代肾脏工作，不影响和朋友去喝茶，去工作，去热爱生活......

我们共同期待着新技术能造福全人类，让我们的肾友过上更好的生活！更好的解决后顾之忧。

参考资料：

AWAK Technologies Wearable Peritoneal Dialysis Device Granted Breakthrough Device Designation by the US FDA.

World’s first wearable peritoneal dialysis device to be safe for end-stage renal disease patients

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FDA原文：

AWAK Technologies Wearable Peritoneal Dialysis Device Granted Breakthrough Device Designation by the US FDA

Singapore, Jan. 08, (GLOBE NEWSWIRE) --Singapore, 8 January – AWAK Technologies (AWAK), a pioneering medical technology company focused on dialysis using regeneration technology for end-stage renal disease, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its AWAK Peritoneal Dialysis (AWAK PD) device, a wearable and ultra-portable PD system that incorporates AWAK’s patented sorbent technology.

A world-first, the AWAK PD device disrupts the mode of delivery in which peritoneal dialysis is currently administered. The device allows dialysis to be performed “on-the-go”, overcoming the challenge of long hours of therapy and connection to large-size dialysis machines, currently faced by renal patients. End-Stage Renal Disease affects 650,000 patients per year in the US.

According to the FDA, Breakthrough Device Designation is granted to expedite the development and review of certain devices that demonstrate potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. To qualify as a Breakthrough Device, there must either be no FDA approved alternative treatments available or the technology must offer significant advantages over the existing approved alternatives.

This designation was granted by the FDA after reviewing the results from the First-In-Human safety trial of AWAK PD device which was successfully completed in October at the Singapore General Hospital, Singapore’s largest acute tertiary hospital. The trial results showed that AWAK PD was able to efficiently remove the accumulation of toxins from the body and patients in the trial did not experience any serious adverse events during dialysis with AWAK PD.

Suresha Venkataraya, Chief Executive Officer, AWAK Technologies, said:“Breakthrough Device Designation is an important milestone in the development of AWAK PD following the recent positive clinical study results. The designation reinforces our belief that AWAK PD has the potential to revolutionise the way in which peritoneal dialysis can be delivered and we look forward to collaborating closely with the FDA on the next stages of our development pathway.”

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