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 (WAK) designed by Beverly Hills, Calif.-based Victor Gura, MD the inventor of this technology. The announcement was made during the opening session on Sunday of the Annual Dialysis Conference taking place in Atlanta.
The WAK from Blood Purification Technologies is a winner of the FDA award Innovation 2.0 an award from the FDA. The FDA Innovation program is intended to assist developers of dialysis technologies in obtaining accelerated approval to reach patients in a safe, timely, and collaborative manner.
Gura, a physician at Cedars Sinai Hospital and a Clinical Associate Professor from the David Geffen School of Medicine at UCLA commented:
“Our scientific team worked intensely for about a year in close collaboration with a dedicated team from the Center of Devices and Radiological Health of the FDA to make this approval happen.
“We are especially grateful to the talented hard working team from the FDA for their support and guidance in achieving this milestone. It establishes the FDA’s commitment to bring about changes in healthcare through innovative technologies developed in the US.”
Gura added: “Since its inception, more than 50 years ago little has changed in the way we deliver dialysis with machines that immobilize patients for many hours. Chronic dialysis is neither natural nor physiological as we replace the natural function of a human organ with a machine. However given the deadly alternative and the lack of available organs for transplant it is the best alternative we can offer to patients with kidney failure. While the dialysis industry appears to be faring well, dialysis has become institutionalized and, satisfied with what we have wrought in this field, we continue piling small improvements on top of other minor advances in dialysis technology and that ultimately current dialysis technology is entrapped in its own net for failure to break out in new directions. On the other hand the WAK has the potential of radically changing the way dialysis is provided and might offer substantial costs reductions, and the hope of improving quality of life and decreasing mortality in dialysis patients.”
Gura also indicated that the WAK clinical trials will be carried out in several academic medical centers of excellence including the University of Washington and other major universities in the US.