|The Wearable Artificial Kidney (WAK)--Courtesy of Stephen Brashear|
Months after clearing the Wearable Artificial Kidney (WAK) for human clinical trials, the FDA gave medical researchers a green light to begin the first human study of the device in the United States.
Federal regulators and the University of Washington Institutional Review Board accepted protocol for safety and performance testing of WAK, a miniaturized dialysis machine that is worn like a belt and connects to a patient through a catheter, MedicalXpress reports. Testing is slated to begin this fall in an inpatient hospital setting at the UW Medical Center in Seattle, and up to 16 patients will be accepted into the trial.
Researchers developed the device to untether patients from large dialysis machines and give individuals with end-stage renal failure more mobility during treatment, Dr. Victor Gura, WAK's inventor, told MedicalXpress. Unlike traditional dialysis machines, the device runs continuously on batteries and weighs only 10 pounds. WAK has already been tested on a few patient volunteers in Italy and Great Britain, but the current trial will fully evaluate the device's efficacy in human subjects.
Designed by Beverly Hills, CA-based Blood Purification Technologies, WAK is one of three devices reaping the benefits of the FDA's "Innovation" program, a pathway designed to fast-track approvals for products that treat end-stage renal disease (ESRD). According to regulators' estimates, more than half a million people in the U.S. suffer from ESRD, and the costs associated with the disease topped $29 billion in 2009. Other products selected for the program include an implantable renal assist device under development at the University of California, San Francisco, and a hemoaccess valve system designed by Greenville, SC-based CreatiVasc Medical.
Meanwhile, patient groups and med tech companies are pushing for expedited regulatory approval for devices that satisfy an unmet need. Earlier this year, the FDA proposed a new, fast-track PMA process for devices that treat life-threatening diseases or conditions. The process would cut review time for devices by about a third to 12 months, according to estimates by the Evaluate Group.
- read the MedicalXpress article