|Ready for the first trials for the wearable artificial kidney.|
Those of use with functional kidneys can’t fully appreciate the annoyance of being on dialysis. Patients are often tethered to these machines two or three times per week for several hours at a time, but a small trial could change all that. The FDA has granted preliminary approval for doctors to test a wearable artificial kidney that can handle dialysis while the patient goes about his or her business.
The Wearable Artificial Kidney (WAK) is not a small device, but it is technically wearable at about ten pounds. Most of the components are mounted on a belt around the midsection, but there are also some shoulder straps that help hold it up. The pumps and filtration systems built into the WAK are able to filter the blood as efficiently as a dialysis machine that weighs many times more.
Just like a real kidney, the WAK filters the blood to remove the waste byproducts of human metabolism. In patients in late-stage kidney failure, these toxic metabolites can build up to dangerous levels in mere days, requiring hospitalization. This is one of just three projects chosen by the FDA to proceed to clinical trials as part of its Innovation Pathway program, an initiative started in 2012 to get breakthrough medical devices to patients faster. Approval of medical devices can often take years, and the WAK has already been in development for a decade.
The first trial of the wearable kidney will be small, just 16 total participants. Doctors hope 10 of them will complete the inpatient study. Their blood levels will be checked periodically over the course of 24 hours using the WAK to see if it is keeping up with the needs of the body. The test will then go on for 28 additional days with occasional checks to make certain there are no ill effects. If it works, the WAK could be scaled down and made more comfortable for long term use.