Dear AfibApnea,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?
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.