This is not intended to be an advertisement or anything. I was alerted by a friend that this treatment would soon be available. Does anyone know anything about it? It sounds interesting if it works. The statistics cited seem a little inflated to me.

If anyone has any experience or thoughts on this, please share.

http://www.imtheramedical.com

tntjr wrote:

This is not intended to be an advertisement or anything. I was alerted by a friend that this treatment would soon be available. Does anyone know anything about it? It sounds interesting if it works. The statistics cited seem a little inflated to me.

If anyone has any experience or thoughts on this, please share.

http://www.imtheramedical.com

I thought to myself.......this good be great.

I checked through their site. Quite impressive, medic controlled..........should lead to safety for the patient (well more than an OTC device).

I couldn't find any mention of FDA or CE Approval.

Finally, I noticed at the bottom of the page...........'not for sale in the USA'

Looks like it hasn't received any formal approval on either side of the pond. I certainly wouldn't rule it out..........BUT I have no intention of putting myself forward as a guinea pig.

In fact, on checking the site a second time..............they might as well be selling a tooth brush as there is no mention of any medical studies, except that they mention studies that prove that 46% of CPAP users give it up ???? I would love to see these studies.

I would like to see something like this working...............BUT until such time as there is solid evidence (not sales hype) that it does.......might be best to leave it alone.

Daniel.


_________________
The untreated Sleep Apnoea sufferer died quietly in his sleep.......
Unlike his three passengers who died screaming !!!!!!

(Anon)

I agree. But if this is for real, it could be a sign of some really interesting things to come. I think I recall being told that they are waiting for U.S. approval, but until then they are offering it elsewhere.  I could be wrong though. I plan to keep an eye on it though.

tntjr wrote:

I agree. But if this is for real, it could be a sign of some really interesting things to come. I think I recall being told that they are waiting for U.S. approval, but until then they are offering it elsewhere.  I could be wrong though. I plan to keep an eye on it though.

It can't be offered in Europe unless it is CE Approved............takes just as long as FDA, and being FDA Approved does not guarantee CE Approval and vice versa.

This type of option was trialed back in the late 90's/early 2000's, and doesn't appear to have worked.

I would like to see some medical trials on this device, particularly over the longer period.............it just might be the device we have all prayed for.

Daniel.


_________________
The untreated Sleep Apnoea sufferer died quietly in his sleep.......
Unlike his three passengers who died screaming !!!!!!

(Anon)

They've only just gotten clearance by an "ethics committee" to start clinical trials in Belgium.  Yet they're expecting to publish results in the first quarter of 2010?   Maybe the investors buy that, but I live in the reality-based community.  I think I'd better zip my lip because I'm way too close to one of the principals to comment more specifically.


_________________
Marie
Newbie with Severe OSA
ResMed S8 Elite II CPAP with EPR and H4i humidifier
ResMed Mirage Quattro full face mask
Contec CMS 50-E Pulse Oximeter

mreewh wrote:

They've only just gotten clearance by an "ethics committee" to start clinical trials in Belgium.  Yet they're expecting to publish results in the first quarter of 2010? .

Sure they can if they have 10 patients, make it a short trial, and submit to a rapid publication journal. That also assumes that they can recruit their patients quickly.


_________________
SleepyToo
Philadelphia Area
Diagnosed September 2009, Respironics System One w/ C-flex and humidifier
Opus 360 Nasal Pillows (previously used nasal masks)

SleepyToo wrote:

Sure they can if they have 10 patients, make it a short trial, and submit to a rapid publication journal. That also assumes that they can recruit their patients quickly.

All I can say is that one of their principals apparently didn't learn his lesson at his last employer, where this strategy backfired in a big way for a number of different products and applications.


_________________
Marie
Newbie with Severe OSA
ResMed S8 Elite II CPAP with EPR and H4i humidifier
ResMed Mirage Quattro full face mask
Contec CMS 50-E Pulse Oximeter