Replies to This Discussion

Permalink Reply by Scott E on February 29, 2012 at 5:15pm

Thanks for the info, Heather. I believe (fear) the Revel is the same as the Veo, but with certain features disabled to gain FDA approval. Those features are, you guessed it, LGS and the more-than-3-day-sensor.

Permalink Reply by Heather on February 29, 2012 at 5:20pm

How irksome. What's the FDA's problem with the 3+ day sensor?

Permalink Reply by Kate's Mom on January 25, 2013 at 6:16pm

Scott, I was told no. The Enlite will only work with Veo that is part of what is taking so long for approval.

Permalink Reply by Heather on February 29, 2012 at 12:01pm

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).

Permalink Reply by CAMAJohn on February 29, 2012 at 3:06pm

thanks..keep us updated how its going

Permalink Reply by Mike S. on February 29, 2012 at 6:25pm

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.

Permalink Reply by Asma on March 4, 2012 at 3:59pm

I'm not sure about the US. I already have mine and I live in Saudi Arabia. Usually, products aren't approved here if they're not released yet in the country of origin.

Permalink Reply by Tom Goffe on June 20, 2012 at 11:10am

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.

Permalink Reply by BSP on July 12, 2012 at 2:09pm

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.

Permalink Reply by Kate's Mom on January 4, 2013 at 3:49pm

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)

Permalink Reply by Tobiwan on January 25, 2013 at 1:56pm

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

Permalink Reply by Sportster on January 31, 2013 at 6:53am

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.

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