In November last year, Dr Victor Gura spoke at the Kidney Week 2015 at the American Society of Nephrology Annual Meeting, about his wearable kidney device which has now passed its third proof of concept trial. The latest breakthrough was that six out of seven trial patients remained hemodynamically stable for 24 hours and fluid removal was consistent with the prescribed ultrafiltration. 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. Patients were told to eat foods that are high in phosphorous, and all the electrolytes remained stable, even in the absence of phosphate binders.
Dr Gura, a nephrologist at the Cedars Sinai Hospital in Los Angeles and the David Geffen School of Medicine at the University of California, says “The draconian impositions we make on these patients in terms of not only being tethered to a machine (‘doing time’ as patients say) but also the limitations of diet — two glasses of orange juice and a bag of potato chips is enough to kill these patients — don’t make for a very good life” and “We do not do a good job at answering the unmet needs of our dialysis patients”
So that is why he invented this wearable artificial kidney device (WAK), which is nine-volt battery operated and easy to carry on your waist as a belt. It gives patients freedom to move around by reducing the functions of a 300 pound dialysis machine into just 11 pounds. It also uses just half a liter of water instead of the 40 gallons normally needed during a hemodialysis session. The WAK has been tested in laboratories and clinics since 2001 by medical clinicians, biomedical engineers and other medical researchers. It is manufactured by Blood Purification Technologies in Beverly Hills.
The device was awarded a special FDA fast track to market status in April, 2012 as one of three products related to end stage renal disease; thanks to the support of a program called Innovation Pathway, a system designed to help medical devices reach patients in a safe, timely and collaborative manner.
Chuck Lee was the first U.S. patient supplied with the WAK. Now 73, he has been struggling with diabetes for 40 years and been on traditional dialysis three times a week for more than two years.
You can see an interview where he discusses his experience in this clinical trial and with the Wearable Artificial Kidney here: https://www.youtube.com/watch?v=IkRhnjDVZzE
One of the things he most enjoyed was that “…during the trial I just ate whatever I felt like, like I had a double order of macaroni and cheese for dinner, I ate Cheetos all night long, I drank orange juice and tomato juice which are both high in potassium, which is another one you have to watch out for, it was just like gosh this is so great!”
Dr Gura stated that “The limiting factor to have patients using this device is money, but we have now proven the concept in Italy, London, and now Seattle, and it’s time to get serious and make things happen, and we will.”
Despite the fact that the commercial availability of this device is probably many years away, the news is very promising as a possible life changer for many patients. Currently, the only treatment available for patients on dialysis is a kidney transplant, and only a small amount of these patients get one due to the lack of kidney donors. And unfortunately, the number of kidney failure patients is growing in the U.S., according to the U.S. Renal Data System 2015 Annual Data Report. So the reality is that a treatable fatal disease may now go either untreated or poorly treated.
Other alternatives to dialysis that have been proposed to date are “xenotransplanted kidneys”, supported by the Starzl Institute at the University of Pittsburgh; “bionic” kidneys; and simplified dialysis regimens. Dr. Eli Friedman, a distinguished teaching professor from the Downstate Medical Center in Brooklyn, New York invented a “suitcase kidney” that could be taken on trips and was easy for patients to use. However patients who took it home and on trips with them reported it to be bulky and burdensome and preferred going to a dialysis center for treatments.
That is why Dr Gura and others have worked on making the device lighter and simpler to be used as a portable device that subjects can wear while living something close to a normal lifestyle.
At this point, there are many studies being carried out to help improve these patients’ lives. Such as using Nanotechnology to create an implantable artificial kidney, that can imitate a kidney and remove enough waste products, salt and water to keep patients off dialysis. And also probiotic bacteria that patients can take orally and it would digest the retained wastes of uremia and detoxify patients with end stage renal disease.