Nephrology News & Issues

A trifecta for home dialysis with new technology

A trifecta for home dialysis with new technology

by Mark E. Neumann

A trifecta for home dialysis with new technology

When big events occur in home dialysis, you need to celebrate––particularly in the United States, where the modality option represents less than 12% of the total patient population.

The Annual Dialysis Conference, held here this past week, had some significant announcements for those interested in dialyzing at home.

• NxStage Medical demonstrated its recently received U.S. Food and Drug Administration approval for nocturnal home hemodialysis with its SystemOne portable hemodialysis machine. In the ADC exhibit hall, the company booth was complete with a full-sized bed and the presence of two NxStage nocturnal home dialysis patients. Robby Richardson, a NxStage patient since 2011 from Savannah, Ga., has used all modalities of therapy.

“I hate to use terms like “quality of life” but I honestly never thought I could feel as well as I do again, “ said Richardson. “My life literally went from spending all my spare time in my bedroom with the Xbox in my sweats to going back out into the world and being a part of it again. I met someone. We got married and thank goodness, I do nocturnal dialysis because I am always running around.”

Tina Harrison, a military wife and NxStage patient since 2010, said, “Now that I dialyze while I sleep, I can spend the evenings with my family. I don't feel like I am missing out. I get to eat dinner with my family. During the days I can go on day trips and not worry about getting hooked up by a certain time.”

NxStage, which has been working for some time on getting the indication approved, says there are a number of benefits of a longer, overnight therapy. “Home nocturnal hemodialysis allows for expanded flexibility in dialysis dose and schedule, better enabling physicians to match individual dialysis prescriptions to each patient’s health care and lifestyle needs. By performing therapy while sleeping, patients are able to clear their schedules for other activities, and reduce the overall burden of therapy.”

• Baxter Health Care’s renal division displayed new technology for both peritoneal dialysis and hemodialysis patients during the conference. At the company’s booth, the dialysis machine manufacturer offered attendees a peak at Amia, its new PD cycler. Baxter says the machine is more user-friendly by including a touch pad system for patients and it is about 10 lbs. lighter than Baxter’s current PD cycler. While the device is FDA approved, company officials could not say when the machine would be available to the renal community.

Baxter also showed off for the first time in the United States its new Vivia home hemodialysis system. Results from two studies conducted in the United States and Canada showed acceptable clearance of uremic toxins and an overall safety profile similar to that associated with conventional HD devices. The VIVIA system completed the CE marking process in Europe in December 2013.

The first in-human study was a prospective, single arm clinical study conducted in hemodialysis centers in the United States, in which 22 patients received four HD treatments with the VIVIA HD system every week for 10 weeks. The mean duration of each HD treatment was 3.8 hours.

In a second prospective, single arm clinical study conducted in hemodialysis centers in Canada, 17 patients received nocturnal HD treatments with the VIVIA HD system three times per week, for six weeks. The mean duration of nocturnal HD treatment was 7.0 hours.

Having choices in dialysis care is important, especially when it comes to modality options. It's good to see that industry continues to pursue better ways to deliver renal replacement therapy.

This article was posted on February 13th, 2015