The FDA approves trial for wearable artificial kidney - looks like it will begin soon.
What is AWAK?
AWAK stands for Automated Wearable Artificial Kidney.
How does AWAK work and how is it different from current treatments?
AWAK is based on peritoneal dialysis, one of two forms of dialysis that the majority of patients are medically eligible to receive.
In peritoneal dialysis, dialysis fluid (or dialysate) is pumped into the peritoneal cavity, a space in the abdomen (stomach area) that surrounds the abdominal organs. Toxins and wastes are then cleared from the blood through the peritoneal membrane, the lining of the abdomen or peritoneal cavity. The peritoneal membrane acts as a filter to remove impurities from the blood while at the same time preventing important components of the blood, such as the red and white blood cells and proteins from leaking out into the dialysate. In essence, the peritoneal membrane serves the same function as the normal kidneys, which act to filter out impurities from the blood and excrete them in the urine.
After several hours, the used dialysate containing the blood toxins is then drained from the abdomen and replaced with new fluid to restart the process. For patients who undergo peritoneal dialysis, this process is normally done at home several times per day after a period of training at a dialysis center.
With the AWAK device, patients will continue to have dialysate fluid placed into their abdomen. The major and most important difference from peritoneal dialysis is that patients being treated with AWAK do not have to regularly replace the dialysate. This is because the dialysate is continuously regenerated by the AWAK technology. As such, the dialysate within the machine can be replaced once every 2-3 months. The device is also portable, allowing patients to have much more freedom of movement and to pursue activities they enjoy with much less restriction.
The AWAK machine can also be disconnected for several hours at a time, allowing patients to pursue any activity they would otherwise be medically cleared for, including swimming and intensive sports!
One other advantage of continuous dialysis through the AWAK device is that blood toxins are constantly being removed at a steady rate. As such, patients may be less likely to experience such symptoms as nausea and tiredness that can occur after haemodialysis treatments, when the blood contents and toxins are suddenly removed over several hours.
Who can use AWAK?
AWAK is appropriate for any patient with end-stage kidney disease who can receive peritoneal dialysis. Patients who are not able to receive peritoneal dialysis for any reasons, e.g. prior abdominal surgery or infection/scarring, are similarly not suitable for AWAK therapy. Most patients who require dialysis are able to receive peritoneal dialysis.
I’m currently on haemodialysis, is it still possible to use AWAK, which is based on peritoneal dialysis?
Yes, with the consent of your kidney doctor (nephrologist). As long as your doctor agrees that you are a candidate for peritoneal dialysis, the doctor will arrange for a simple operation where a small cut is made in the abdomen so that a catheter (tube) can be inserted. The AWAK device will then be connected to the catheter. The catheter is securely held in place and cannot become dislodged. Similarly, it is not noticeable under clothing and does not limit your physical activity when disconnected.
What about reliability? Is it safe to use AWAK?
Yes. AWAK will go through the different stages of human clinical trials for safety, efficacy and effectiveness. AWAK will be fully reviewed, approved and licensed by the appropriate authorities, including the U.S. Federal and Drug Administration and the European Union CE System. In addition, AWAK Technologies had successfully obtained the ISO 13485 systems by SGS in September 2008.
Do I need to control my diet and water intake if I were to use AWAK?
No, although you should still follow a diet that is medically sensible for you.
Are clinical trials in process?
Clinical trials are scheduled to start in 2014.
Will I be able to travel long distance (e.g. by airplane) with AWAK?
Yes. With a wearable dialysis machine, you will be able to continue dialysis wherever you are or whatever you are doing. For rigorous exercise or such activities as swimming, you can even disconnect the AWAK for short periods of time, up to several hours.
Will I still need to attend regular medical appointments while using AWAK?
Yes. You will still need to meet with your physicians regularly. If your AWAK therapy is going well, appointments with your kidney physician (nephrologists) may only be once a month.
http://www.awak.com/wearable/faq.htm
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