Medtronic Inc. said Friday that it has won U.S. government approval for what it said is the first artificial pancreas system that automatically stops insulin treatment for diabetics when the patient has had enough.
People with Type 1 diabetes have a pancreas that is unable to produce insulin, a hormone that regulates blood sugar, or glucose, Medtronic said. An artificial pancreas closely mimics the insulin delivery of a healthy pancreas.
The new device, called the "MiniMed 530G with Enlite," works by sensing the amount of glucose in the patient's blood stream, then turning itself off when glucose levels drop to predetermined level if the patient hasn't already responded to an alarm.
Medtronic characterized the artificial pancreas system as a breakthrough that "can help people gain better control of their diabetes versus multiple daily injections."
The Fridley-based medical giant said the artificial pancreas system is for patients who are at least 16.
The Enlite is a glucose sensor that Medtronic said is 31 percent more accurate than previous sensors used for that purpose. The sensor can be worn for six days.
The MiniMed 530G with Enlite will become available in the next several weeks at a retail price for $7,350, said Amanda Sheldon, a Medtronic spokeswoman. Patients with insurance typically would pay $500 to $1,200 out of pocket, she said.
Before delivering the product, Medtronic must first make unspecified manufacturing changes that were suggested by the Food and Drug Administration.