Dr. Victor Gura began creating the initial models for his Wearable Artificial Kidney (WAK), in an exam room in his Beverly Hills medical offices 10 years ago. He is a kidney specialist and an Associate Clinical Professor at UCLA, specifically working with patients on dialysis. His goal was to create a Wearable dialysis machine, so patients would not have to be tied down for many hours to a big machine, and would get more dialysis time but feel much better as they could walk around with a miniaturized battery operated machine worn as a belt.

Earlier this month, Gura’s WAK was one of three projects accepted into the Federal Drug Administration End Stage Renal Disease (ESRD) Innovation Challenge. The ESRD Challenge is an accelerated program to assist new projects in dialysis treatments, in getting fast approval from the FDA to make it available to the public in the US.

Over 2 million people throughout the world are on dialysis, and in the US about 20 percent of dialysis patients die every year.

“When the kidneys fail, the poisons accumulate in the body,” Gura said. “The vast majority of the patients who need a transplant will die before they get it. So, dialysis is the main solution, and consists of running the patients blood through a large machine connected by two thick needles to cleanse the blood.

Patients on dialysis have a better quality of life if they are able to undertake dialysis every day, but that requires many more hours of care, that doctors and nurses can’t offer in beds they don’t have. If not, toxins build up in their blood, and life becomes uncomfortable and limited.

“Society doesn’t have the financial resources to pay for daily dialysis,” Gura said. “I need to improve the quality of life for my patients.”

The WAK is the first miniaturized dialysis machine of its kind in the world. It is battery operated and uses very little water as compared to the currently used machines. Gura said that in the past some Nephrology specialists have been skeptical of the WAK, but that now his concept has gained world wide acceptance.

“We can’t continue doing business as usual because too many people suffer too much, and the high mortality is unacceptably high ,” Gura said. “We had to come up with something better for them. The only reason you become a doctor is either to alleviate suffering or save lives. This is like being a doctor on steroids because now I hope to be saving a lot of lives through the device.”

Gura said the WAK has been tested in the lab, on pigs, and in two successful human trials in Italy and the United Kindgdom. Now, it will undergo trials across the country, in different facilities including the University of Washington, Downstate New York, UCSD and Vanderbilt, for different periods of time. He said he is hoping the trials will be completed in less than two years.

“We have definite estimates of what the pathway should be, but now that the FDA is involved we are much more confident that collaborating with their team may help us do things better and faster” Gura said. “I’m elated to work with the FDA. The FDA has been demonized but [from] what I encountered, they are a wonderful group of people, modest, knowledgeable, smart and trying to do good.”

http://bhcourier.com/article/Local/Local/Beverly_Hills_Doctor_On_Fast_Track_To_FDA_Approval_For_WAK/87992

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