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Apnex Hypoglossal Nerve Stimulation System
#21
(07-29-2012, 08:44 PM)JJJ Wrote:
(07-29-2012, 07:30 PM)Jeanne Lynne Wrote: I had the APNEX device implanted in January and just completed my six month study. All is perfect and I am sleeping like a baby. I also have energy all day long! Best decision I ever made. If anyone has questions, please feel to contact me or ask questions here.

I have a few questions.

1) I understand there is a pacemaker-type device that sends the currents up the wire to stimulate the throat muscles. Is this device implanted under the skin? What does it use for a power supply and how long does it last?

2) What happened during the six month study? Were you monitored like in a sleep lab? Every night, or periodically, or how often?

3) Do you recall how severe your sleep apnea was before the procedure, like AHI numbers from previous sleep studies? And do you have numbers for what it is now after the procedure?

Thanks for posting about your experience. I know a lot of people are interested in the APNEX device.

Hi JJJ,

The pacemaker like device is implanted just under the collar bone on my right side. I know one of the fellows in my study group had it put on the left side so he could still hunt. I have a lead that goes to my diaphragm and one to the HP nerve in my jaw. The device has a battery that is changed about every 5 years. Implant was simple. I had it Friday and was back to work on Tuesday. Only a little discomfort after implant. I am not aware of it at all now.

I was monitored via 3 or 4 sleep studies over 6 months. I went in weekly for a download of the data in the device showing how well I was using it. Length every night, how many times I paused it and to move the titration up slowly. I started at .7 milliamperes and hit their goal of 1.6 after about 4 months.

I will look up my numbers but I can tell you that in initial sleep study I had 468 arousals over 6.5 hours. The three month study I was at 137 arousals over 7.5 hours. I do not have results from six month study but my guess is little to no arousals.

Jeanne
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#22
While this is invasive, it doesn't sound like a very risky procedure as long as you are otherwise healthy. I like that the procedure is reversible if it just doesn't work for you. Please keep us updated as to your experience. Best of luck! While JJJ is asking for data on efficacy, I guess we won't have all of that until these studies are completed. I am glad that there are pioneers out there like andrwoo, who are willing to participate in these studies. I would imagine that one criteria for his participation was his failure with CPAP, or even his discomfort with CPAP after trying everything else. As JJJ suggests, I can't imagine this procedure would work for all forms of OSA.

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#23
Hi Everyone,

Well it has been 8 months sine I had the APNEX device implanted. It works so well and has really improved my life. The down side of being in a study like this.......

I received a call that the study has been suspended indefinitely while the company reorganizes. This means funding I am sure. I was told I could have the device explanted or just keep using it without monitoring until the battery runs out in three to 5 years!?!?

I would be interested in your opinions !

Jeanne Lynne
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#24
Wow. Yeah, that's a bummer.

I would call them back and ask what will happen in 5 years. Will they be around to take care of it the battery? Can it be removed by any surgeon or one of theirs? If they don't think they will be around then or if they are wishy washy on the answers, I'd have that thing removed now. If they are the only ones that truly understand how this thing works, who will take care of you in the future??
PaulaO2
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#25
Good point PaulaO2. Hubby and I have been talking it over and he is in your court. I just hate losing the benefit and freedom from it.

Jeanne Lynne
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#26
Hi Jeanne,
I was implanted in July and was in the treatment group. My AHI dropped to 7. I feel great. I got through the funding crisis to be told today of the decision to shut the trial down due to the control group's improvement that killed the statistical significance of the treatment group. This has scared off the investors and is shutting down the trial. I was presented with the explant before march first paid for by apnex. The FDA wants the units shut down with the magnet until then. So, do I have the explant, or keep the device until the battery dies in about 4 years, and then have it removed at my cost?
What a dilemma.

Have you heard anything else?

(I am choosing to stay anonymous in case Apnex is watching)


(09-14-2012, 03:37 PM)Jeanne Lynne Wrote: Good point PaulaO2. Hubby and I have been talking it over and he is in your court. I just hate losing the benefit and freedom from it.

Jeanne Lynne

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#27
Hi hgns patient,

My doctor called me Friday and told me the study was being stopped as the FDA doesn't feel there is enough patient improvement to continue the study. Really bad for me. The device has worked really well for me. I have had it for one year and just completed the one year study. Jan 2012 480 arousals in 6 hours. Jan 2013 3 arousals in 8 hours. No noise when I sleep, wake up refreshed and blood pressure is down 20 points.

My doctor told me that I can keep it and use it until the battery runs out but there will be no support. There is also a fund to pay for explanting through 2015 for his program. So I also have to make decisions.

I am looking at the Inspire Medical product here in Minneaplous and the ImThera in San Diego.

Jeanne Lynne
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#28
Hi again hgnspatient,

I was also contacted by someone in NY today with the same issues, different rules for explanting. Check the Apnea Support Forum.

Jeanne Lynne
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#29
(01-22-2013, 10:57 PM)Hgnspatient Wrote: (I am choosing to stay anonymous in case Apnex is watching)

I guess not a bad idea although you really are among friends.
Congrats SHa_clap2 on such a courageous move - I mean the surgical approach. I've had more surgery in my life than anyone should ever have, several dozen, and would avoid it if I have the option (usually I don't). So best wishes. I wonder how you would adjust such a thing if your needs change. I've realized that the CPAP pressure has had to be increased for me over the years.
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#30
Hmmm. Interesting. I think I'll stick with my CPAP for now though. Wink
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