The US Food and Drug Administration (FDA) has granted clearance to NxStage Medical’s System One hemodialysis device.
Solo Home Hemodialysis
The FDA expanded the indication for the NxStage Medical System One to include solo home hemodialysis. However, the patient must remain awake, reported medGadget. Physicians must prescribe the machine for patients to use the therapy at home. The System One is a portable device that can be placed in a room and used as directed by a physician. Risks are increased if the patient is performing hemodialysis alone. So patients should be well trained and ready to seek help if an emergency arises.
Previous History of Home Based Hemodialysis
FDA approval required patients enlist a care partner or a home care assistant. The device is suitcase size and was first approved for home dialysis in 2005. In 2014, the FDA cleared the device for nocturnal hemodialysis with a caregiver present.
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.
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.
NxStage Medical, a company in Lawrence, MA, US that focuses on hemodialysis equipment, won FDA clearance for its System One to be used by the patients at home and by themselves.
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