Miniature Portable Dialysis Machine on Fast Track for FDA Approval

By: | November 9th, 2014

Portable Dialysis Machines A Reality

Dialysis machines are needed by patients with renal (kidney) failure to clean their blood of wastes produced by the body. In 2008, Dr. Victor Gura, an internationally known kidney specialist at Cedars-Sinai Medical Center, proposed the first miniature portable dialysis machine..

An Alternative to Conventional Dialysis

The US Food & Drug Administration’s (FDA) fasttrack program, Innovation Pathway, streamlines the approval process for breakthrough technologies. In 2012, the “Wearable Artificial Kidney” (WAK), promoted by the Wearable Artificial Kidney Foundation, Inc., was awarded fast-track status, along with two other renal projects.

Since then, WAK has made progress with its wearable dialysis machine and is currently involved in animal trials; human trials scheduled for 2017. The current prototype weighs just 10 pounds and can be carried about the waist of the patient. Another company, AWAK Technologies, has developed a WAK for Peritoneal Dialysis called “ViWAK PD” that weighs just two pounds.

Wearable Organs Should Eventually Lead to Implantable Organs

The WAK is simply a miniature dialysis machine enabled with wireless technology that sends information to a remote monitoring system. As time goes on and these devices become smaller and smaller, implanting is expected to be the norm.

In the meantime, current WAK devices will allow dialysis patients to return to a more normal routine while having their vital signs, fluids and electrolyte balance continuously monitored.

The following video shows Dr. Jonathan Himmelfarb, a University of Washington nephrologist talking about WAK and the prospect of coming clinical trials:

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David Russell Schilling

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