Re: an OSA implant?
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Re: an OSA implant?

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Posted by Anthromed on July 10, 2012 at 09:25:45:

In Reply to: an OSA implant? posted by Pinski on August 17, 2010 at 11:39:28:

Hi, I am curious about the interaction of HGNS (Apnex, Inspire)
devices with MMA surgery and if anyone has any experience or
insights on that.

I'm wondering if MMA can still be done after an HGNS device is
implanted if it is not successful. Conversely can HGNS be
effectively used after MMA? I am wondering if there are clinical
reasons that either approach should or could preclude the other
in terms of scar tissue, physiological results etc.? Which should
one pursue first, MMA or HGNS, in patients with mild to
moderate OSA?

Unfortunately I believe that currently in the USA for research
purposes clinical trials for HGNS require that the patient has not
undertaken MMA surgery to that point (this is an exclusion
criteria). I suspect this it to reduce the number of confounding
variables.

However I believe that these devices are approved in Europe so I
wonder if it might be possible for a US citizen to travel there to
get them if they didn't qualify for a clinical study here due to
prior MMA or want to wait until they are approved by the FDA
(probably a long time)?

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