FDA approves Aksys home dialysis system

Published Saturday, 20 April 2002 3:36AM CST by in ESRD

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Aksys Ltd.‘s Personal Hemodialysis System (PHD System) has received approval by the U.S. Food and Drug Administration (FDA). Home hemodialysis has been around for a while, so some coverage of the company’s announcement has been overblown.

What sets the Aksys PHD System apart is that it’s the first dialysis machine designed specifically for home hemodialysis. This is important for several reasons:

  • End-stage renal disease (ESRD) patients can dialyze themselves overnight. No dialysis center in my area, for example, offers overnight dialysis sessions.
  • Some studies indicate that home hemodialysis is safer than in a dialysis center.
  • Some studies indicate that daily dialysis is more beneficial to the patient.

From my perspective, there are several disadvantages, as well. I’ve been on dialysis for a little more than two years and in that time I’ve seen patients develop serious problems (including death) pretty regularly. I’m concerned that were I to develop a serious problem during the run (so far, it’s only happened once) I’d rather take my chances with nurses with 30+ years of experience. After all, there’s little that I can do for myself if I code or become unconscious during a dialysis run at home. In addition, I’ve been resistant to having all the mechanical crap associated with the dialysis machine—tubes, needles, dialyzers, water lines, chemicals, the machine itself, etc.—in my home.

Even with those reservations, the notion of being able to dialyze myself overnight, while I sleep, is hugely appealing. Right now I spend between 10 - 12 hours each week at the dialysis center. And that doesn’t factor in the considerable recovery time after each run.

According to the National Kidney and Urologic Diseases Information Clearinghouse, there are 3,600 dialysis centers in the United States, serving more than 240,000 ESRD patients. Surprisingly, and perhaps alarmingly, the number of new dialysis patients has increased 7% each year for the past five years.

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