Wearable Artificial Kidney finally gets FDA approval for US trials

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Wearable Artificial Kidney was a concept introduced back in 2009, this medical gadget hopes to transform the lives of millions of patients suffering from kidney disorders.

The miniature, battery-powered dialysis machine gets the green light for human testing in the United States by the Food and Drug Administration with the first human clinical traits scheduled to take place in Seattle later this year. The medical gadget was developed by a team of researchers headed by Victor Gura and others from ULCA. It’s a miniature dialysis device that straps on like a tool belt and is connected to the patient by means of a catheter. According to the team, patients would no longer be wasting time in long, boring dialysis sessions, but will have the freedom for movement and freedom to eat and drink while the wearable gadget purifies their blood on the go.

As opposed to the conventional dialysis machine found at hospitals or in homes, which tend to be the size of a filing cabinet, the current version of WAK weighs only 10 lb (4.5 kg) and the doctors hope the final version will be lighter and smaller.

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This is very important because earlier, patients had to be tethered to a large dialysis machine three times a week for four hours at a time. But now, the new device could change all that. The patient can undergo the treatment while he or she goes about his or her business. The new device includes all the components of a conventional dialysis machine, but with a few modifications. For one, it’s run by a battery and second the tool doesn’t require an external source of pure water, instead filters the water that was used and sends it back into the device. This is one of the three proposals out of 32 candidates approved by FDA to proceed to clinical traits as part of its Innovation Pathway Program.

The trial will involve up to 16 patients with 10 to complete the inpatient study. Their blood samples will be checked periodically while the patients are allowed to move around free. There will be a 28-day follow-up observation period. So, if WAK works well, it will become a game changer.

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Via: Gizmag