Medtronic obtains FDA clearance for artificial pancreas system

29 September 2013 (Last Updated September 29th, 2013 18:30)

Medtronic has obtained US Food and Drug Administration (FDA) approval for its first generation artificial pancreas system, the MiniMed 530G with Enlite, with Threshold Suspend automation for diabetic patients.

pancreas system

Medtronic has obtained US Food and Drug Administration (FDA) approval for its first generation artificial pancreas system, the MiniMed 530G with Enlite, with Threshold Suspend automation for diabetic patients.

It is reportedly the first system in the US capable of automatically halting insulin delivery when sensor glucose values fall below a predetermined threshold and when the patient fails to respond to the Threshold suspend alarm.

The MiniMed 530G system features the new Enlite sensor, Medtronic's most accurate and comfortable continuous glucose sensor with a 31% improvement in overall accuracy compared with the previous versions.

The Enlite sensor can detect up to 93% of low blood sugars when predictive and threshold alerts are turned on.

The new sensor is 69% smaller and can be worn for six days; it also features a 'hidden-introducer needle' for simple insertion.

The targeted patient market for this artificial pancreas system are people with diabetes ages 16 and older.

"We are committed to advancing closed loop algorithms, continuous glucose monitoring and insulin delivery technologies to bring new artificial pancreas systems to market."

In accordance with the product approval requirements, Medtronic will conduct a post-approval study, engage in direct patient follow up and also make certain manufacturing accommodations.

Medtronic president Diabetes business Katie Szyman said: "The MiniMed 530G with Enlite is expected to help people gain better control of their diabetes versus multiple daily injections.

"We are committed to advancing closed loop algorithms, continuous glucose monitoring and insulin delivery technologies to bring new artificial pancreas systems to market."

Medtronic plans to ramp up production and prepare for a launch of the MiniMed 530G in the next several weeks.

According to GlobalData estimates, Diabetes Care Devices market in the US was valued at $7.58bn in 2012 and is expected to grow at a CAGR of 5.1% to reach $10.74bn by 2019.


Image: MiniMed 530G with Enlite. Photo: courtesy of Medtronic, Inc.