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The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home. All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One dialysis system consists of an electro-mechanical cycler and a disposable Cartridge Extracorporeal Blood and Fluid Circuit (NxStage Cartridge). The NxStage Cartridge is available with a pre-attached high permeability dialyzer, together referred to as the "NxStage Cartridge Express". The NxStage Cartridge Express filter is made up of a fiber bundle maintained within a polyethylene terephthalate glycol (PETG) dialyzer housing. The polysulfone fiber bundle is a semipermeable, hollow fiber membrane through which water molecules and smaller molecular weight solutes pass from the blood to the dialysate, but larger molecular weight solutes (such as proteins) do not. Uremic toxins and waste products are removed from the patient's blood by means of diffusion during hemodialysis.