Victor Gura's Wearable Artificial Kidney: The FDA Approval Path

By Peter Laird, MD

The FDA Innovation Pathway recently selected three new technologies for this new program. Dr. Victor Gura has been testing prototypes of his WAK for several years and now will focus his future efforts through a collaboration with the University of Washington in Seattle. Many patients have expressed interest in this new and exciting technology that promises a new level of renal replacement therapy rivaling transplant. Looking at data from an earlier prototype compared to standard therapies illustrates well the potential of this modality.

In this graphic representation, the prior WAK prototype achieved 25 ml/min clearances. Keep  in mind that his latest prototype achieved 40 ml/min clearances specifically designed to deliver a large enough clearance to allow children to grow. Even at 25 ml/min clearances, the WAK would deliver more total daily clearance than daily nocturnal treatments currently achieve. The FDA path to approval was also considered in the application for the FDA Innovation Pathway. 

These five successive clinical studies will have to show significant benefit and no harm to the patients as the trials progress through these individual stages. All of these proposed trials will be randomized and controlled. The FDA approval of the path to marketing this device sends an important message throughout the dialysis industry. The future of renal replacement treatments not only with this device but many other proposed medical devices also working their way through the system should give all with ESRD a new hope of a promising future.

There were thirty two new technologies submitted for approval of this program and the FDA chose these three as the starting point of the new Innovation Pathway.  The fact that we have over thirty new devices developed far enough to consider human trials gives us all hope that the treatments of today shall soon be eclipsed by superior devices. Dr. Gura's WAK opens the doors for a new future and I look forward to seeing the developments of this technology in the next few years.

(Slides courtesy of Dr. Victor Gura)

Comments

[George]

Wow, that would be amazing for the device to come out.

My question is does a higher kt/v mean better quality of life or longer survival. Many papers showing both sides.

[Peter Laird, MD]

Dear George, I am going to assume the higher Kt/V HEMO study as the one that did not show an improved survival. HEMO followed the NCDS two decades before that has doomed dialysis patients to a miserable life and death for the average American dialysis patient for over 30 years. The biggest problem with the HEMO study is lack of separation of study subjects looking at total time per week of dialysis with only a 16% difference.

In addition, Kt/V does not correlate well to outcomes once you are above a threshold of 1.2.

On the other hand, if you look at total time on dialysis with such studies as the Pauly daily nocturnal dialysis study showing equal mortality to cadaveric transplant, yes, the WAK would offer substantial health benefits and mortality from a theoretical perspective. The operative aspect is not so much the projected Kt/V but total time on dialysis and it is the first continuous hemodialysis option set forth for human trials in the US.

It is an important development that will likewise push the industry in a new technological direction and that is the most important message of the WAK.

[Rose]

Really like the blog, appreciate the share!

[Judith Kelly]

I feel I am a perfect candidate for a Wearable Atificial Kidney. I first required hemo dialysis in 1966, I rec'd a successful cadaveric transplant in May of 1969, which lasted 32 years. When my Imuran was reduced, I lost that wonderful kidney I rec'd another from my sister in 2001 which only lasted 3 years. I have been back on hemo since.
According to my Neurologist, I have Urea Neuropathy and will only get relief from 24/7 kidney function/dialysis. I am in pain & am losing my ability to walk more & more. I need help
Judy

[Peter Laird, MD]

Dear Judith, unfortunately, the WAK is years still in the making before it comes to the general market. Currently today, the best solutions we have are home daily hemodialysis and renal transplant. If you are waiting for another kidney, the best bridge to transplant is daily home hemodialysis. That market is likewise waiting for FDA approval of several devices that many state will come and truly open competition in an industry with little technological advance in decades.

[Amanda Wilson]

What I haven't been able to work out is whether this is PD or Hd? Icannoti agile weari g this 24 hours/ day. Just the weight of a Holter monitor drove me mad. I am Hopi g the pic. Shows a prototype and the finished product will be smaller. If this is an HD dialysis device, I would have concerns about the the fact that access is via a catheter. I think that I will wait it out, and hopefully the implantable artificial kidney will become available in a few years.