FDA approves trial for wearable artificial kidney
April 2017 update
Jonathan Himmelfarb, MD, gave an update on the development of a wearable artificial kidney at the 2107 National Kidney foundation Spring Clinical Meetings
The logical progression of dialysis treatment improvements, according to Himmelfarb, would be portable (think a smaller, lighter version of the NxStage System One), wearable, and implantable. And through the Kidney Research Institute and the University of Washington, Himmelfarb is working on the wearable. Read more
May 2016 update
Nov. 2015 update
The wearable artificial kidney has passed the first FDA-approved proof-of-concept trial, Victor Gura, MD, FASN and other researchers announced at the American Society of Nephrology’s Kidney Week 2015. The device was developed by Gura, from the David Geffen School of Medicine at UCLA. The present prototype of the WAK is a 10-pound device, powered by nine-volt batteries and worn around the waist.
Six out of seven patients ambulated while receiving WAK treatment, according to the abstract presented at Kidney Week. Fluid removal was consistent with prescribed ultrafiltration rates. Mean blood flow was 42 ± 24 and dialysate flow was 43±20 ml/min with no laboratory evidence of hemolysis. Mean BUN, creatinine, and phosphorus clearances were 21 ± 13, 20 ± 11, and 22 ± 12 ml/min respectively during the first hour of treatment.
In one subject, treatment was discontinued due to clotting after four hours. In a second subject, treatment was discontinued due to discoloration of dialysate observed after 10 hours. The trial was stopped after the 7th subject due to device-related malfunctions that included excessive CO2 bubbles in the dialysate, variable blood and dialysate flows, and tubing leaks during the priming phase. Redesign and re-manufacturing of the WAK prototype will be required prior to additional human studies.
“The data provides proof of concept that the WAK is an effective and safe dialysis device that will greatly improve quality of life for ESRD patients, Gura said. “The results suggest that the WAK has the potential to reduce patient mortality and cut the exorbitant cost of treating kidney failure.”
According to Gura, the current WAK prototype will become smaller, lighter and easier to wear. The device has already passed proof of concept studies in Italy and England.
ATLANTA (Feb 10, 2014) — The U.S. Food & Drug Administration has approved the start of the first human clinical trials in the United States for the wearable artificial kidney designed by Beverly Hills, Calif.-based Blood Purification Technologies Inc. The announcement was made by Victor Gura, MD, during the opening session on Sunday of the Annual Dialysis Conference taking place in Atlanta.
The device was one of three products related to end-stage renal disease that were awarded a special fast-track to market status in April 2012. The program, called Innovation Pathway, is a new system designed to help medical devices reach patients in a safe, timely, and collaborative manner. An implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco, and a Hemoaccess Valve System (HVS) designed by Greenville, S.C.-based CreatiVasc Medical were also awarded FDA fast track status.