Medtronic’s new artificial pancreas system gets FDA approval

Windsor Genova – Fourth Estate Cooperative Contributor

Minneapolis, MN, United States (4E) – Medical devices maker Medtronic has announced the government’s approval of its new artificial pancreas system for diabetics.

The company said on Friday that its MiniMed 530G with Enlite is the first in the United States that can automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient doesn’t respond to the Threshold Suspend alarm. The system will suspend all insulin delivery for two hours. Insulin delivery can be resumed at any time.

The new device features the new Enlite sensor, Medtronic’s most accurate and comfortable continuous glucose sensor with a 31 percent improvement in overall accuracy from the previous generation. Wearable for six days, the Enlite sensor detects up to 93 percent of hypoglycemia episodes when predictive and threshold alerts are on, according to Medtronic.

Hypoglycemia happens when there is low blood sugar in the body. If an insulin pump continues to deliver insulin to someone experiencing hypoglycemia, there is the danger of inadequate supply of glucose to the brain, resulting in impairment of function. The effects are confusion, blurred vision, seizures and loss of consciousness. On rare occasions, it can cause permanent brain damage or death.

The new Medtronic system includes a pump worn externally. The pump communicates wirelessly with a continuous glucose monitor to deliver the optimal amount of insulin to patients.

The device addresses a pervasive fear among diabetics that their blood-sugar levels may drop precipitously while they sleep, possibly leading to a coma, according to Star Tribune.

As its name implies, the MiniMed 530G is 69 percent smaller than the previous Medtronic sensor, to deliver improved comfort in using continuous glucose monitoring. The new Enlite serter provides a simpler sensor insertion process with a hidden-introducer needle.

Medtronic said the Food and Drug Administration (FDA) approved the use of the device for diabetics 16 years old and above.

The MiniMed 530G with Enlite can help people gain better control of their diabetes versus multiple daily injections,” said Katie Szyman, president of the Diabetes business at Medtronic.

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