<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Nightwriter</b></i>
The FDA has NOT approved the eflow. It "cleared" the e-flo which is entirely different. Every pharmacy that distributes the eflow (now called Trio) has this disclaimer on its website:
*Disclaimer: The eFlow ® nebulizer has not undergone human clinical studies to determine its safety or efficacy and has not been approved by the FDA for use with tobramycin in the treatment of Pseudomonas aeruginosa in patients with cystic fibrosis. Compounded prescriptions are not evaluated by the FDA for safety or efficacy.
This is why my insurance company as well as many of yours will not pay for it's purchase and why some doctors will not approve it. Many companies will give you the device for free if you take an inhaled antibiotic every other month.
I wanted to try it, but I will have to pay out-of-pocket $1700 plus (with all the additional heads) if I want it.
Recently, there was a trial with an inhaled antibiotic that used the eflow but the researchers were told there was not enough data, so it was not approved by the FDA. (it should have been approved, but that's another story). Had this drug made it through, the FDA would have APPROVED a specific drug to be used in the eflow which would have made it more available to everyone.
BTW, Pari told me that the Pari-Trek would not change the size of Tobi's droplets, but it would take much longer to nebulize. To settle the controversy, I e-mail Pari through this site and they chose not to answer. I suggest all of you bombard them with this question because they do not want to give a definitive answer. They should be held responsible for some answer about THEIR product.</end quote></div>
The verbiage the FDA uses around medical devices (not medication ) is approval, not cleared. Any of your PARI or other compressors are "cleared" and not "approved" as well. Just semantics
When new devices come to market, they are not required to undergo tests with every single medication on the market. This is not how device approval works.
New medications, however, are required to be associated & approved with a specific drug.
Every compressor creates liquid into steam for nebulization. So of course the PARI Trek doesn't change the size of TOBI droplets... the trek CREATES the mist. Whether or not TOBI is translated into a respirable dose, able to be used in the lungs to have antibacterial effects is the issue.
*This will be a fun question: Has the PARI Trek ever undergone human trials with TOBI? Better yet, has PARI Trek been "FDA Approved" for TOBI use?
The answer to both is no.
So if you're using the PARI Trek with pulmozyme, albuterol, TOBI, colistin, HTS or anything else, it's just the same as using the eFlow with pulmozyme, colistin, tobramycin, etc.
Ever used colistin? Colistin is only FDA approved for IV use. No human trials of colistin (that I'm aware of) in nebulization.
It's important to understand the full story.
Did you use digestive enzymes before 2007? Guess what - they never underwent FDA clinical trials. No FDA approval there. They came on the market prior to the FDA.
