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FDA Approves First-Generation Artificial Pancreas From Medtronic, Sends Warning Letter Too


Posted in Regulatory and Compliance by Arundhati Parmar on September 27, 2013

Medtronic announced on Friday that the FDA has approved its MiniMed 530G with Enlite sensor, that has the capability of automatically suspending insulin delivery if it detects low glucose threshold and when the patient doesn't respond to an alarm that is sent.

This is big leap in artificial pancreas development given that for some patients a low -glucose threshold may occur at night or early mornings when they are sleeping. Traditional pumps lacking this Threshold Suspend automation capability will continue to deliver insulin endangering the sleeping patient who may not have responded to the alarm.

Here's how one patient tweeted her response to the news of the FDA approval. 

In a news release, the Minnesota device maker said that the Enlite continuous glucose sensor has shown a 31% improvement to overall accuracy compared with previous generation products. The product is approved for use for those who are 16 and above.

"The diabetes community has eagerly awaited approval of this system that stops insulin delivery when sensor glucose values fall below a predetermined threshold," said Richard M. Bergenstal, M.D., executive director of the International Diabetes Center at Park Nicollet Health Services in Minneapolis and Clinical Professor for the Department of Medicine at the University of Minnesota, in Medtronic's news release. "We are hopeful that advances such as this and improvements in the accuracy of continuous glucose sensors will help people with diabetes strive for better control of their diabetes."

Patients on a company blog also hailed the availability of this technology but were curious about pricing and insurance reimbursement.

Jennifer Carwile Posted on Fri Sep 27 13:43:29 GMT 2013
would be nice to have, since I have Low Blood sugar unawareness, and I have had several mornings where I have not woken up because my sugars went low. Its so hard not being in control of your body, But insurance companies don't seem to be sympathetic.
- See more at: http://www.loop-blog.com/blog/Introducing-the-MiniMed-530G-with-Enlite#s...

While this is a first-generation artificial pancreas, there are technological advances that Medtronic and other companies are sure to pursue. And that would mean developing a pump that not only can suspend insulin delivery when a low-glucose threshold is reached, but also predict one

Meanwhile the announcement of the approval also comes with an acknowledgment of an FDA warning letter that a diabetes facility in California received on Sept. 19. Because of that and a condition for approval, Medtronic will conduct a post-approval study as well as do a direct patient follow-up, among other things. 

 

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com
 

 


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