Medtronic Artificial Pancreas Wins FDA Approval

The MiniMed 670G insulin pump is the latest step toward creation of a fully automated, closed loop system.

Chris Newmarker

Medtronic MiniMed 670GFDA on Wednesday announced approval of the MiniMed 670G insulin pump, which its maker Medtronic touts as the world's first hybrid, closed-loop artificial pancreas. 

The 670G is the first FDA-approved device intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses, according to FDA. 

Medtronic plans a commercial release of the MiniMed 670G in spring 2017.

"This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a news release

Wednesday overall was a big day for diabetes devices: Abbott Labs announced FDA approval of its Freestyle Libre Pro glucose monitoring system, a small, adhesive sensor that is able to collect up to 14 days worth of continuous glucose results to help doctors better evaluate how people are managing their diabetes. 

The 670G marks the fourth of six stages Medtronic is going through to develop what has been a holy grail for diabetes devices for decades: an almost entirely automatic "closed-loop" insulin pump system that does away with the constant glucose testing and insulin adjustments that diabetes patients presently go through.

In the case of the 670G, the device measures glucose levels every five minutes and then automatically administers or withholds insulin. Users, though, still need to manually request insulin doses to counter meal consumption. 

A clinical trial involving 123 people with type 1 diabetes found the device is safe for people 14 years and older to use, with no serious adverse events, diabetic ketoacidosis (DKA), or severe hypoglycemia (low glucose levels) reported during the study. (Medtronic is presently conducting clinical studies involving 7- to 13-year-olds; the device is presently only approved for people who are 14 and older.) 

Diabetes treatment is an increasingly important area for Medtronic. Diabetes group sales were up 10% during the quarter ended April 29, driven largely by sales of the MiniMed 640G insulin pump outside the United States. Insulin pump sales overall grew by more than 30% outside the U.S.

Brush up on your connected health knowledge at BIOMEDevice San Jose, December 7-8, 2016.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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[Image courtesy of Medtronic]

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