Wearable Artificial Kidney Greenlit For Safety Testing
the Renal and Urology News take:
Researchers expect to start safety and performance testing of a Wearable Artificial Kidney (WAK) this autumn. The WAK is a miniaturized dialysis machine that can be worn on the body.The device connects to the patient via a catheter and is worn on a tool belt-like carrier.
Like a conventional dialysis machine, it filters the blood of patients whose kidneys have stopped working. Unlike current portable or stationary dialysis machines, the WAK can run continuously on batteries and is not plugged into an electrical outlet or attached to a water pipe. The current model weighs about 10 pounds, but future modifications could make it lighter and more streamlined.
Currently, dialysis patients have little ability to move around during treatment. Dialysis sessions are time-consuming and frequent, occurring around three times a week and lasting for 3-4 hours each. Researchers developed this device to give end-stage renal failure patients freedom during their dialysis treatments. The WAK was one of three proposals out of 32 applications chosen by the Food and Drug Administration (FDA) to participate in its Innovation Pathway program. The program was designed to encourage the timely development of safe, breakthrough medical products. To test the WAK under the FDA’s criteria, up to 16 patients will be selected with the goal of 10 completing the full trial.
The testing will be conducted in an inpatient hospital setting at UW Medical Center in Seattle. Clinical measurements will be made during and after treatment with the WAK, and the patients will then be observed for at least 28 days. The safety and performance of the WAK must be evaluated before any additional studies are held.
Researchers expect to start testing the Wearable Artificial Kidney this autumn.
Medical researchers have received approval to begin safety and performance testing of the Wearable Artificial Kidney. The federal Food and Drug Administration and the University of Washington Institutional Review Board accepted the protocol for the clinical trial. Expected to start this autumn in Seattle, it will be the first human study in the United States to be conducted on the device.
The Wearable Artificial Kidney, also known as the WAK, is a miniaturized dialysis machine that can be worn on the body. The carrier resembles a tool belt; the device connects to a patient via a catheter. Like conventional dialysis machines, it is designed to filter the blood of people whose kidneys have stopped working.
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