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Enlite Launched

Discussion in 'Continuous Glucose Sensing' started by HERMSman, Apr 11, 2011.

  1. HERMSman

    HERMSman Approved members

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    MEDTRONIC LAUNCHES MORE ACCURATE AND COMFORTABLE SENSOR

    TO HELP IMPROVE GLUCOSE CONTROL

    Enlite? Sensor Available to Diabetes Patients for Continuous Glucose Monitoring in More Than 35 Countries

    MINNEAPOLIS ? April 11, 2011 ? Medtronic, Inc. (NYSE: MDT) announces the launch of Enlite? Sensor, the newest and most advanced glucose sensor for continuous glucose monitoring (CGM), in more than 35 countries outside of the United States. CGM has been shown in multiple landmark clinical studies to help diabetes patients achieve better glucose control without increasing hypoglycemia (low blood sugar), a dangerous and potentially life-threatening complication of diabetes. The Enlite Sensor combines greater comfort with improved glucose sensor performance in both overall accuracy1 and hypo detection2.



    When the Enlite Sensor is used with the predictive alerts feature on Medtronic systems, diabetes patients have access to hypo detection rates up to 98%.3 This helps give early warning to people with diabetes so they can take action to prevent dangerous hypoglycemia, which is one of the major concerns of people living with diabetes.



    ?The Enlite Sensor will improve patients? ability to predict and detect hypoglycemia, which can be one of the most frightening aspects of living with Type 1 diabetes,? Emanuele Bosi, professor of Endocrinology, Head of the Department of Internal Medicine, San Raffaele Scientific Institute and San Raffaele Vita Salute University. ?CGM is an important element in managing diabetes. The STAR 3 trial demonstrated that diabetes patients achieved better glucose control when sensors were integrated with insulin pump therapy compared to multiple daily injections. Moreover, other recent studies continue to suggest that the more often patients use CGM, the greater average glucose control they can achieve without increasing hypoglycemia.?



    Significant design improvements make Enlite Sensor more comfortable and easier to use than the previous sensor. In a clinical study of Enlite Sensor, 85% of patients agreed that sensor insertion was pain free and 86% agreed that the Enlite insertion device was easy to use4. The Enlite Sensor is a significantly smaller sensor compared to Medtronic?s previous product --69% smaller in sensor size by volume, 38% shorter in length.5 Adding to patient convenience, the Enlite Sensor can be worn on the abdomen and buttocks and used for up to six days.



    ?The adoption of CGM is growing rapidly, as both diabetes patients and their diabetes care professionals experience the benefits of seeing fluctuations in glucose patterns so that action can be taken to achieve better diabetes control. By making the new Enlite Sensor smaller, as well as easier to insert and wear, we expect that more people with diabetes will be able to utilize this technology to manage their condition and ultimately improve their lives,? said Katie Szyman, president of the Diabetes business and senior vice president at Medtronic.



    The Enlite Sensor received CE (Conformit? Europ?enne) Mark approval in Paris, France and is being launched subject to other local approvals in more than 35 countries. Medtronic is working closely with the U.S. Food and Drug Administration on plans to commercialize the product in the United States. The Enlite Sensor is labeled for use with: MiniMed Paradigm? REAL-Time System, MiniMed Paradigm Veo? System, Guardian? REAL-Time Continuous Glucose Monitoring System, and the iProTM2.
     
  2. Jensmami

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    That is good news, lets hope they are able launch it here pretty quickly!
     
  3. selketine

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    Thanks for the good news! I look forward to seeing it released in the USA.
     
  4. frizzyrazzy

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    I can't even begin to wrap my head around the fact that this sensor is good enough for the entire rest of the universe but the FDA finds it so risky that it can't be sold here. Or MM knows they won't make any money on it and / or has a huge backlog of old sensors which they need to exhaust first.
    According to this:
    http://www.diabetesmine.com/2011/04...a-the-medtronic-diabetes-advocates-forum.html

    These sensors are never going to be approved here until we get a new pump to go with them. And I don't know who to blame for that. Someone is to blame.
     
  5. Helmut

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    I will not get a pension and I have to pay for theirs so that they can sit on their hands and delay perfectly fine products. I cannot wait for the next election. I am so sick of big government.
     
  6. Danielle2008

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    Can they not just market the sensors as 3 day wear only out here? Would that require going through FDA all over again?
     
  7. Helmut

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    The FDA would require a human trial if MM changed the color of the packaging for the current sensor.
     
  8. frizzyrazzy

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    funny, that's what people said 2 years ago... shrug.

    This isn't a political thing. Please don't make it one. The FDA does what it does regardless of big government or small government or party in power.
     
  9. Helmut

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    I am just frustrated. I could have a sensor that is 50% smaller, more accurate, with a 1 hour start-up and a better range right now if the FDA was not in the way. Or buy it out-of-pocket in a country that is out of FDA's reach. Politicians can fix anything they want. Isn't this what they are here for?
     
  10. jules12

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    Wouldn't it be more of a programming issue with the software in the pump? Maybe I am way off base but couldn't they just upgrade the software without having to have a new pump for those who would order the new sensors?

    Our pump is out of warranty beginning in May, I hope it lasts long enough for us to purchase a new one that will work with the new sensors. This is just frustrating becase we would use cgms even more if I didn't have such a time inserting the old kind.
     
  11. albasmom

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    It's so exiting, I am however really irritated that I have to wait another month before I can buy them. They are launched in Denmark, but are apperantly not in stock, and we were told that it would be a month before we can order them, even though they were launched yesterday. I know it's nothing compared to the wait you guys have in the US, but I was really looking forward to getting them now. As soon as we get them, I will post here.
     
  12. hawkeyegirl

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    I am very anxious to hear the reviews of actual users!

    And I, too, am frustrated that 35 countries have deemed the Enlite safe enough to use, and we have to sit around waiting 1-2 years for it.
     
  13. emm142

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    I hope these are available in the UK soon! Can't wait to hear reports from real people using them. :)
     
  14. Lize

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    Just heard that we will be able to buy the new Enlite Sensor within the next 2 months. Already launched here. I am just sooooo exited! It will come in a box of 5 which will then cover a whole month (6 days x 5) and thinner and it's own adhesive which will cover the transmitter as well and I do believe even more accurate.

    :eek::)
     
  15. show2tj

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    in UK?

    Is this just curently available in UK?
     
  16. emm142

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    Damn. Available in the UK, but they won't be funded for me. The national health service were funding one box every six months. A box of Enlites costs over 120 pounds more, and yeah... that's not going to happen. I wish I could afford to fund OOP. I could afford the occasional box of the old ones to fill in a gap, but.. yeah. Sigh. Stupid D stuff. I just feel so, so much safer with a sensor on. [/vent]

    I hope they'll keep selling the old ones.. who knows how long for, though.
     

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