I wear the minimed and would prefer to stay wearing one device, but might end up going with Dexcom if Medtronic's Enlite is a long way away. Has anyone heard of a release date for the U.S.?
Thank you for any and all replies!!
How irksome. What's the FDA's problem with the 3+ day sensor?
Scott, I was told no. The Enlite will only work with Veo that is part of what is taking so long for approval.
Several companies outside of North America sell the Enlite. I've yet to find one that will ship to Canada (or the U.S.), but I've recruited a friend who frequently travels to Germany to help me out. Just received my first supply of 5 sensors yesterday. I ordered online from www.DiaShop.de and had the sensors shipped to my friend's mother's place (but we could have used his company's office address as well). A VAT charge of about 50 euros was added to the original cost of 322 euros (I may be able to claim back the VAT — need to check that out), so obviously, without insurance coverage, it ain't cheap to acquire these things!
I didn't bother with the inserter, as that was going to be another 90 euros. I was able to insert the sensor without it (following a video I found on YouTube), and the whole process was a lot more comfortable than with the "Sof-Sensor" (there's a misnomer if I've ever heard one!).
Anyway, the biggest issue is of course the accuracy of the thing, followed by its duration. Since I'm only on day 1, it's a bit hard to comment on either of those, but if anyone's interested in knowing how it goes, just post a reply.
I've pretty much given up on the Sof-Sensors (even though I still have some in the fridge), which seem to have become even less reliable than when I started using them. I phoned Medtronic customer service for every one of the last four that I used, and they were very quick to offer replacements (unlike in the early days, when they seemed to assume user error and go through a pile of questions and verifications).
thanks..keep us updated how its going
Remember Wiffy....we are in the USA. The FDA (Federal Drug Administration, for our UK friends)- it takes forever to get any approval. Politics are involved. Go figure.
Minimed filed for Pre-Market Approval with the FDA on June 8, 2012. In a press release published by Reuters it was stated that both the Enlite sensor and the pump with the low glucose suspend feature were included in the filing. Details are available here.
As for the answer to the question of when patients will be able to use these two items: no telling.
I'll be starting in a clinical trial next week. The results of this trial will be given to the FDA to approve/deny the enlite sensor, Revel 2 and Veo being sold in the US. The study is expected to last 4-5 months, so depending on how long the FDA takes to look over the results of the trial, I would guess at least 1 year.
According to my rep., the Veo pump and Enlite sensor will be packaged together. Enlite will not be FDA approved to work with current Revel pump. Also, reps are being trained on the new system now....approval is supposed to be very soon...so soon that some people have been told not to order more than one month supply of current sensors. The new transmitter is supposed to be smaller and lasts for 6 days. A blogger who tested it says the old transmitter will work for the initial three days and then recharged may work for 3 more...but not the twelve she could squeeze out of the Enlite (recharged after 6 for an additional 6)
Have been told by my rep "any day now" and there is a post on medtronic's site that any purchase of a new revel B4 Feb something will be upgraded to new technology at no additional cost. So my guess is that medtronic has finally paid enough to the FDA to finally get it passed for use in this country.
I hope that this is true
My Endo told me at my last appointment (Jan 23, 2013) that the Veo Insulin Pump & Enlite Sensors are now available. You can check it out on the Medtronics website. The sensors will work with the Revel pump also. The CGM starter kit cost is somewhere around $375 at this time. Regular price is somewhere around $1600.