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Here is an excerpt from a document ResMed submitted to the FDA:

"The main differences between Quattro Air and the predicate maskMirage Quattro are in the number of components, their geometry and how individual components interface with each other. These technological characteristics do not impact the fundamental operating principle of the device nor its therapeutic effect. Performance data is available to show that no new questions of safety or efficacy have been raised as a result of these differences." (510(k) Summary [http://www.accessdata.fda.gov/cdrh_docs ... 123979.pdf].)

Hello All!

Just a short comment. The idea of losing the seal with the Mir FX seems to be quite common. I had a patient use Lansinoh on the cushion and even with the strap adjusted loosely, the mask stayed in place all night. I know it's preferred for nasal pillow masks, but it seems to work with the Mirage and Quattro Fxs, and probably would work with this one as well.

Jim

jdm2857 wrote:The headgear attachment has not been a problem during the few nights I've used the Mirage FX;
the mask riding up and irritating the bottom of my nose has been.

+1 (on occasion) By and large I never had a problem with the Mirage FX. Despite chunkyfrog's reservations about the headgear attachment, it never came loose or off during the night on me and I never had seal or leak problems with it.

My first impression is that it will be a big improvement on the current Mirage Quattro.

How long does it usually take from submission to the FDA then to approval and then to market?

According to the above quoted document:

http://www.accessdata.fda.gov/cdrh_docs ... 123979.pdf

looks to be about 6 months.

The commercial looks like it was written by the Wachowskis:

http://www.rmdassets.com/masks/quattroa ... oAirLaunch

mollete wrote:The commercial looks like it was written by the Wachowskis:

http://www.rmdassets.com/masks/quattroa ... oAirLaunch

Watching the video, I was thinking of The Flying Wallendas!

Regards, Nate

SleepWellCPAP wrote:Hello All!

Just a short comment. The idea of losing the seal with the Mir FX seems to be quite common. I had a patient use Lansinoh on the cushion and even with the strap adjusted loosely, the mask stayed in place all night. I know it's preferred for nasal pillow masks, but it seems to work with the Mirage and Quattro Fxs, and probably would work with this one as well.

Jim

Just tried 7 ffm's, one at a time, and I'm a little sensitive to what we all do to get a good seal with our masks/each required 1/2 day vacation time taken, and although service was good that is a very heavy load. (I don't get as many vacation days as I would like.)

I've never heard of Lansinoh. Please elaborate.
Thanks
Dave
Toronto

DaveL wrote:I've never heard of Lansinoh. Please elaborate.

Here are 23 threads that mention lansinoh in the title:
search.php?st=0&sk=t&sd=d&keywords=%2Bl ... =titleonly

Jay thank you for posting. (and thanks; I didn't do a search, and should have.)

Lansinoh?

So it's lanolin?
http://www.amazon.ca/Lansinoh-HPA-Lanol ... s=lansinoh