04-07-2013, 03:23 PM
Wearable Artificial Kidney to Be Tested in Seattle
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A wearable artificial kidney, designed as a new treatment for kidney failure, will be tested in Seattle. The trial will be done in collaboration with the Food and Drug Administration under a new Innovations Pathway announced Monday.
The battery-powered wearable artificial kidney in its current form weighs about 10 pounds and is worn in a belt around the waist. Dr. Victor Gura, an associate clinical professor at the David Geffen School of Medicine, University of California, Los Angeles, invented the device. His goal is to free end-stage kidney disease patients from being tethered for several hours for three or more days a week to a dialysis machine. The hope is to improve the quality of life of these patients.
The Wearable Artificial Kidney is being developed by Blood Purification Technologies Inc. based in Beverly Hills, Calif..
The first United States trial of the Wearable Artificial Kidney will be conducted in Seattle in collaboration with Dr. Larry Kessler, professor and chair of the Department of Health Services in the University of Washington School of Public Health, and Dr. Jonathan Himmelfarb, professor of medicine, and director of the Kidney Research Institute at UW. In 2008, the Kidney Research Institute was established by the non-profit Northwest Kidney Centers and UW Medicine.
The FDA conceived the Innovations Pathway as a joining of forces between the federal regulatory agency and university researchers. The Innovations Pathway will try to expedite the pre-market evaluation of promising medical devices without sacrificing rigorous safety and effectiveness standards. The Wearable Artificial Kidney is one of three devices designed to improve the lives of people with end-stage renal disease that were selected from a total of 32 applications to pilot the new approach to product review. The national pool of applications came from small, start-up businesses as well as academic institutions. The researchers will work closely with the FDA at each step, from research protocol design through final analysis of results and application submittal for putting the product on the market. The collaboration is expected to align the trial with all the bases that must be covered to determine if the technology meets requirements for FDA approval.
Kessler said that the details of the trial and when it will start will be determined in conjunction with the FDA. While the plans are not yet established, he expects that patients in the study initially will wear the device under medical and nursing supervision in the hospital. If the device passes a number of checks, patients will likely then try wearing it on supervised visits away from the hospital.
The Wearable Artificial Kidney connects to a catheter to filter the blood of toxins and excess fluid. The hope of medical researchers is that such a device could, if necessary, operate around the clock, seven days a week like normal kidneys. The wearable artificial kidney has undergone preliminary tests with patients in Italy and the United Kingdom. Under the FDA Innovations Pathway, Gura and a team of medical and public health researchers at the University of Washington, in conjunction with Northwest Kidney Centers, will conduct the first US clinical trial of the Wearable Artificial Kidney.