CAN'T TOLERATE CPAP...NEW DEVICE TO TREAT SLEEP APNEA

[jmh8446805629]

Just wanted to make sure everyone was aware that there is a new therapy out there to treat sleep apnea patients

* Inspire Therapy was approved April 30th by FDA and is now commercially available to patients in US
* Designed for Obstructive Sleep Apnea (OSA) patients who can't tolerate or are non-compliant with their CPAP
* Outpatient surgery, less-invasive involves implantable device + sensing lead + stimulation lead
* Upper Airway Stimulation (UAS) Therapy...stimulates hypoglossal nerve which keeps airway open during sleep.
* STAR trial showed a 68% reduction in AHI and 70% reduction in ODI

* Published in New England Journal of Medicine in Jan '14
* FDA Panel approved Feb '14
* FDA commercially approved Apr '14

More information is available by Inspire Medical Systems on their websites or calling 844-680-5629 to get more information and availability in your area.

[Sleepster]

I'm glad to see this product has made it this far. I remember hearing about it, and I hope it becomes a viable alternative to other forms of treatment.


Moderator Note: I moved this thread from the Main Forum here to the Commercial Forum where it belongs. If anyone wants to discuss the effectiveness of this or any other therapy for SDB feel free to do it here or to start a new thread in the main forum.

[Peter_C]

Well, even with a 68% improvement, it would only lower my AHI to around 25 - so while it may be a possible solution for many, it isn't for those of us rated severe and worse.

[TorontoCPAPguy]

The FDA has been approving a lot of "voodoo medicine" as of late for reasons that I will never understand. All I can say, without further detailed information, is CAVEAT EMPTOR.

[me50]

even with a reduction, a person would still have to use a machine because this procedure doesn't cure OSA. Personally, I will stick with my machine.

[Homerec130]

I took at a look at the web site and this appears to be able to work with only a very small group of sufferers. One of the first things I noticed was that it is restricted to a BMI of less than 32. So much for those who are overweight.

In their FAQ the battery is listed as good for 8-11 years, and is not rechargeable. To replace it requires another outpatient surgery. My wife has a spinal chord stimulator (SNS) with a 10 year rechargeable battery that failed after 9 months requiring an additional outpatient surgery to put it in.

They do make the point of not being able to have an MRI with this. I have seen the results of a SNS that went through an MRI and it was not pretty. Supposedly, there are some pacemakers out there that are MRI safe. Also, I wonder how this would work if someone had it installed and found later they needed a pacemaker or other stimulation device.

Granted, this is a first step, but it appears to be designed for a very small population. Hopefully it will open the doors to new methods of treatment.

Homer

[truckerdad57]

A last thing to consider before you opt for this therapy?

Are you in a safety sensitive occupation subject to fitness for duty physical requirements such as a commercial motor vehicle operator, pilot, or master mariner?

If yes.,.... use Inspire and you will lose your job.

For CMV operators this therapy isn't approved for keeping your DOT medical card. I'm not sure about FAA flight physicals or USCG but doubt they would approve you on it either.

[Homerec130]

Truckerdad57,

Still a lot of gray areas for the FAA. They mention surgery as a viable option, but do not mention the use of a stimulator which is what this really is. There is a lot of documentation required for sleep apnea and proving it is under effective treatment including doing a series of monitored wakefulness tests.

If some one is an active flyer (maintaining a medical certificate) then the best route would be is to have a talk with an AME (Aviation Medical Examiner) as part of the process.

Homer

[EssienM]

Glad to know about the this therapy. Thank you for sharing.