NxStage Medical, a company based in Lawrence, MA that focuses on hemodialysis equipment, won FDA clearance for its System One to be used by the patients at home and by themselves. This is the first such clearance that gives people with end stage renal disease a new level of independence from clinics and at-home carers. While the system can also be used to dialyze blood while the patient is sleeping, doing so without assistance requires the patient to undergo dialysis while awake.
This new regulatory green light will allow considerably more patients to be eligible for at-home dialysis, something that they’ve been restricted from because of a lack of a care partner that is trained and able to help out with the procedure.
The System One is a portable device that can be placed in a room and used as directed by a physician. Risks are increased when performing hemodialysis alone, so patients should be well trained and ready to seek help if an emergency arises.
Flashbacks: NxStage System One Now Cleared for Night Time Hemodialysis in Europe…; NxStage System One Portable Dialysis…
Product page: System One…
Via: NxStage Medical…