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Posts Tagged ‘wearable artificial kidney’

Wearable dialysis

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

This wearable artificial kidney, being tested at UW, just got fast-tracked by the FDA

http://www.bizjournals.com/seattle/blog/health-care-inc/2015/11/this-wearable-artificial-kidney-being-tested-at-uw.html

Annie Zak  Staff Writer – Puget Sound Business Journal

Annie Zak covers the health care and biotechnology industries, as well as transportation.

A device that would provide a massive improvement in treatment for dialysis patients had what was deemed a successful first

A device that could revolutionize dialysis treatment just got the green-light to befast-tracked through the U.S. Food and Drug Administration’s approval process.

The wearable artificial kidney device, or WAK, is currently being tested in clinical trials at UW Medical Center. It is a miniature, 10-pound dialysis machine that a patient can wear around his or her body like a tool belt. The system is also attached to the person using a catheter.

The device is a huge improvement compared to other dialysis machines, which land patients with kidney problems (such as kidney disease) in a chair for several hours, multiple times a week. The WAK instead allows for mobility during treatment.

In the first U.S. clinical trial for the device, the WAK “performed successfully … despite technical issues that halted the trial early.” Seven patients participated in this trial.

As a result, the FDA has granted “expedited access pathway” status to the device. Research and development for the device will be fast-tracked as its components are redesigned to address technical issues. That means it will have a shorter path to market than waiting in line behind other medical devices that are seeking approval.

Developed by Victor Gura of the University of California-Los Angeles, the device is set apart from standard machines because it runs on batteries and has no need to be attached to an outlet.

Trials of the device have already happened in Europe, but these tests at UW Medical Center are the first in the U.S.

 

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