Medtronic, Inc. (NYSE: MDT [FREE Stock Trend Analysis]) today announced the U.S. Food and Drug Administration (FDA) approval of the MiniMed 530G with Enlite, Read more: http://www.benzinga.com/news/13/09/...irst-artificial-pancreas-device#ixzz2g65mvCu2
That's some presumptuous headline they have there. I just cannot see, given the abyssal accuracy of the sensor, that it would be a good thing. roll over, shut off. Yes, that works great.
Because its the next step in the process of a fully automated system, hence the ap terminology. Yes we got the official email this morning. Its good to go!
It is hard to get excited about a sensor that studies have already shown to be less accurate than their competitor's sensor that has been out a year now. At least the days of the harpoon needle are over.
Sorry. I should have ended with one of not I know what it is. I also know what it isn't, but thanks for the lesson
If I read it right, it is only approved for people 16 and older - any idea if they would try or are trying to get approval for younger kids?
Jason, children were on pumps long before they were approved for use in children. Same with insulin. Same with insulin being approved for pump... Doctors can write the prescriptions. Whether or not each insurance company will honor, may be a matter of need to fight for it. Separately, saw this today too : Medtronic details diabetes facility warning letter
That does sound like we could still get it, but I was hoping to take advantage of their technology guarantee for an upgrade but they sent me an email today saying that they cant do the free upgrade because my daughter is only 6. It sounds like they will be trying for approval for under age 16 but I don't know how long something like that could take - if its a from scratch type of deal or if it goes faster having the pump/CGM already being used by other T1's? Anyway we just got the pump 2 months ago and were really looking forward to a free upgrade since we just paid 1000's out of pocket for the current pump. Any insight from anybody on how long approval for younger kids might take or the process involved would be great - thanks for everyone's help on this forum
It just depends on whether they're already working on it or not. They have to do clinical trials on the age group they're seeking approval for and submit the results of those studies to the FDA.
Yes correct. Also you can ask your doctor to write a narrative Letter of Medical Necessity citing hypoglycemic unawareness and multiple events of hypoglycemia. This allows Medtronic pushback when dealing with the insurance. That way we can argue medical necessity for the patient. After that its up to them if they are willing to cover it for a patient under the age of 16. Hope that helps some.
I called medtronic today about ways to get my 12 yo approved for the new elite/medtronic pump. All he could do was recommend discussing the new system with our endo. Since it would be off label use. My son actually has an endo appt. on Monday. How should I proceed to obtain a PA for the new Medtronic system. I know this could take awhile. We got our pump 6 months ago and we were "told about the technology upgrade that is free". I think it would be years before kids are approved. If insurance authorizes the new sensors and pump, do you think medtronic is going to allow a free upgrade? I am going to try to get a letter of medical necessity and take it from there. Any suggestions or insight? thanks . i image this is going to be a long draw out process and can't image how many 16 y/o plus users they have to upgrade first and possible new customers.
Actually Medtronic called 2 weeks ago and said that our Dr had called and pushed it through for our 6 year old and so they are going to give us the technology guarantee upgrade for free? They did say they will be needing our input and will be calling us with questions about how the pump/enlite are working, so I dont know if they are using that info toward some kind of study for kids under 16. Anyway, apparently the Dr has some ability to get Medtronic to do an upgrade for free
