I have heard confilicting information on the NxStage machine. Is it or is it not FDA approved for use on Chronic ESRD patients in the home setting. I am aware that it is used in the Hospital/ICU settings.
Thanks.
The NxStage machine has been approved by the FDA, which means that it can be prescribed by an MD for ANY setting, including home.
If it is being used at home outside a clinical trial it is being used off lable. The NxStage isn’t allowed to be promoted as a home dialysis machine which is why this site does not list it on the products page. Once they get the in line dialysate delivery system up they should be able to promote it as a home machine.
That’s correct–and both of these statements are true. Once ANY drug or device is approved by the FDA, an MD can prescribe it for any purpose that he or she sees fit.
However, only those purposes that are listed in the FDA indication are “on-label.” Any other use is off-label, unless or until another indication is approved by the FDA, which generally takes more research.
I’m looking for dialysis centers or doctors that are referring patients to or training patients on the NxStage System One product.
I’d suggest that you contact NxStage and ask. Look under Contact Us at http://www.nxstage.com. The message says if you’re a patient or family member you can use their contact form and for Nature of your inquiry, choose from a drop down list Find a center near you and NxStage will refer you to a center near you.
Beth,
Thank you for taking the time to look at my inquiry. I already went through that process but haven’t yet heard from anyone at NxStage. I’ll wait and see if they send me something.
Thanks!
Ashlee
Where do you live?
I live in New York.