[QUOTE=Jane;15594]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.[/QUOTE]
This not only does not limit treatment time, it also seems to leave an opening for the dialyzor to be the “trained and qualified person, considered to be competent…”
Just found this on the net accidentally:
NxStage Medical Inc.,
Q4 2007 Earnings Call Transcript
page 3 out of 10
Feb.12, 2008
J. Burbank
>I’m also very pleased to provide an update on our nocturnal trial, news that I think many of you have been waiting for. We’ve received unconditional approval from the FDA to conduct our nocturnal IDE trial, which should lead to an expansion of our indication statement to include nocturnal use. We’re initiating a study over to the next few weeks.
I’m very pleased to be on a path that will add a nocturnal indication to our product. We think this is another application where the market wants a clear device to give them confidence. The trial design is very similar to the one required for the home indication, which took us about 18 months to conduct and gain FDA clearance<
SeekingAlpha.com
I had heard from another source that it might be 3-5 years before NxStage had this indication for nocturnal txs, but according to the above statement, it could be less?? So, is this what stops companies from offering nocturnal on NxStage?