Sleep Apnea Implant - Clinical Study / CPAP Alternative

AfibApnea wrote:Another condition that might prevent one from taking part in the study is having a pacemaker. (I do not know if this would prevent having the device installed.) I answered all the questions in their pre-questionnaire and that was the only one that might have caused them to say I was ineligible for the study.

I was not able to get answers to the following questions from thnstudy.com.

• Is the aura6000 device FDA approved? (I assume not, otherwise they wouldn't be doing a study.)
  Since the device is available in Europe what kind of track record does it have? What website(s) might I go to to find out more about the success/failure of such devices outside of the United States?
  Should having a pacemaker installed make it impossible to have the a6000 device installed?

Dear AfibApnea,

good questions. Here are the answers:

1. The aura6000 is not FDA-approved - it is CE-marked (European approval). The current study is seeking US approval by the FDA.

2. ImThera Medical (the device manufacturer and study sponsor) have executed two previous studies and got the European approval fairly recently. There are about 100 patients implanted overall, but the european operations have just got its head start so a larger sample data will be known in the next few months - all we can tell is that patients are doing very well (testimonials video here: imtheramedical.com/patients). Studies in the next few moths will provide you and doctors much more data. If you would like to find out more about these past studies and their data, you can take a look at the publications in this page: imtheramedical.com/physicians.

3. I think 49er might have answered the "pacemaker" question. For the study itself, sites are not enrolling patients with pacemakers because that could prevent the analysis of issues specifically related to sleep apnea. This doesn't mean that after device approval these patients will be excluded. Just for study purposes, these patients have been excluded. There are patients with pacemakers in Europe (by the way, the device is more often implanted on the right side to leave space on the left for pacemakers).

Best Regards,

sleepingpaul.

More likely, they are worried about interaction of signals between the devices. Jim

I was wondering why my post was deleted. I didnt do it but I have an idea who might have. And I do t really care. I just thought anyone who might be interested in this procedure would like to know if they live in the area.
I'm all done with the games. I never delete posts. Especially someone else's

Also my user used to be Sclark08 but my IPad acted up and I set up new acct. Working fine now. Nothing sinister involved.

Brattygirl65 wrote:I was wondering why my post was deleted. I didnt do it but I have an idea who might have. And I do t really care. I just thought anyone who might be interested in this procedure would like to know if they live in the area.
I'm all done with the games. I never delete posts. Especially someone else's

OK. Thank you for the clarification on that situation.


Den

.

No problem!

Goofproof wrote:More likely, they are worried about interaction of signals between the devices. Jim

Interference should not be a problem for these OSA implants.

The issue for having a pacemaker in a study is that study sponsors want to avoid adding a potential problem/variable not related to the particular study subject (OSA). After/If FDA approves it, having a pacemaker will not be an exclusion criteria for having the sleep apnea implant.

I can understand the desire to eliminate a "wild" variable.
How long has it been used in Europe?

sleepingpaul wrote:

Goofproof wrote:More likely, they are worried about interaction of signals between the devices. Jim

Interference should not be a problem for these OSA implants.

The issue for having a pacemaker in a study is that study sponsors want to avoid adding a potential problem/variable not related to the particular study subject (OSA). After/If FDA approves it, having a pacemaker will not be an exclusion criteria for having the sleep apnea implant.

Basically, like having natural gas in your home and a propane tank in the home, they want to be sure who to blame for the explosion. Jim

chunkyfrog wrote:I can understand the desire to eliminate a "wild" variable.
How long has it been used in Europe?

The very first patient was implanted in Belgium in November 2009, the European approval was made official in 2012/2013. First patient will complete 6 years implanted, doing very well.

sleepingpaul wrote:

chunkyfrog wrote:I can understand the desire to eliminate a "wild" variable.
How long has it been used in Europe?

The very first patient was implanted in Belgium in November 2009, the European approval was made official in 2012/2013. First patient will complete 6 years implanted, doing very well.

Paul,

You might answered this question previously but do you have a link to an official study of how well the patients in Europe are doing? I could have missed it but it seemed what you posted were links to testimonials. That is great the first patient is doing well but that doesn't really tell us anything one way or another.

49er

I received my call from the hospital this morning for my phone interview to see if I qualify for the implant.

First of all, your AHI sleep test without equipment,which you have to take must be 35 or over. And you also have to have BMI over 30 . Then you have to submit to a physical to determine if you are fit for the surgery. The procedure itself takes 45 mm and you stay in recovery about 4 hours.

Then you must return for follow up visits. You are given a remote control which they teach you how to operate and adjustments are made along the way. You are paid a fee they didn't say what and all surgery Meds etc are free.

Unfortunately I didn't qualify for the program

Brattygirl65 wrote:I received my call from the hospital this morning for my phone interview to see if I qualify for the implant.

First of all, your AHI sleep test without equipment,which you have to take must be 35 or over. And you also have to have BMI over 30 . Then you have to submit to a physical to determine if you are fit for the surgery. The procedure itself takes 45 mm and you stay in recovery about 4 hours.

Then you must return for follow up visits. You are given a remote control which they teach you how to operate and adjustments are made along the way. You are paid a fee they didn't say what and all surgery Meds etc are free.

Unfortunately I didn't qualify for the program

BG,

According to the brochure that the nearest sleep study center sent, you have to have a minimum AHI of 20 and the BMI can't be over 35. I thought was pretty standard for the study.

49er

PS - And RDI is not counted so unless my sleep study changes significantly on the 8/31 results (previous AHI of 5.9 and RDI of 23), I will not qualify either.



Brattygirl65 wrote:I received my call from the hospital this morning for my phone interview to see if I qualify for the implant.

First of all, your AHI sleep test without equipment,which you have to take must be 35 or over. And you also have to have BMI over 30 . Then you have to submit to a physical to determine if you are fit for the surgery. The procedure itself takes 45 mm and you stay in recovery about 4 hours.

Then you must return for follow up visits. You are given a remote control which they teach you how to operate and adjustments are made along the way. You are paid a fee they didn't say what and all surgery Meds etc are free.

Unfortunately I didn't qualify for the program

BG, as 49er said, there's no reason your BMI needs to be under 30 to participate... the requirements are BMI up to 35, and AHI higher than 20.

What site/hospital did you contact?

The hospital I spoke to in Louisville requires BMI be OVER 30 not under. I would assume this is a requirement because they want to start out with people that need the most help to assure effectiveness of the program