In 2009, a joint research team from Sinai Medical Center in Los Angeles and the UCLA School of Medicine unveiled a prototype of the Wearable Artificial Kidney (WAK), a medical product that was approved by the FDA at the end of 2014 and entered clinical trials.
The WAK works like a traditional dialysis machine. It also cleans the patient's blood of metabolic waste and impurities, and then delivers the purified blood back to damaged tissues in the body to complete the dialysis process. But a traditional dialysis machine is roughly the size of a cabinet, and even the most advanced dialysis machines are the size of a printer. However, the current WAK device weighs only about 9 kilograms, and researchers are trying to reduce its weight to about 4.5 kilograms.
Patients wearing the WAK will need to change the filter once a week and add chemicals daily to purify the filtered water. In addition, the WAK, which is powered by a 9-volt battery, works automatically. All patients involved in the clinical trial were able to sleep in the WAK, and showers and other normal activities should be no problem, said Victor Gula, a clinical associate professor with the University of California research group.
In the clinical trial, seven patients with end-stage renal disease received WAK for 24 hours. During that time, WAK filtered water and salt from the blood at the same rate as healthy kidneys, and the patients experienced no discomfort or side effects.
However, the device had one major flaw. Two of the seven patients left the WAK in less than 24 hours because of a failed procedure.After the research team deals with this problem, they will conduct a week-long clinical trial of the WAK wear.
The FDA announced last month that if WAK proves to be safe and effective, they will expedite its approval. If the researchers can continue to get funding for subsequent technology development and clinical trials, patients with kidney failure could be wearing the WAK within two years, Gula said.