Medtronic Plc wins US FDA approval for artificial pancreas
29 Sep 2016
Medtronic Plc, yesterday won US FDA approval for an "artificial pancreas", which is the first device to automatically deliver the right dose of insulin to patients with type 1 diabetes. The device would free them from continually monitoring insulin levels throughout each day.
The US Food and Drug Administration, hailed it as it approved the device, the MiniMed 670G.
The device offered type 1 diabetics "greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," Dr Jeffrey Shuren, director of the FDA's medical device division, said in a statement.
According to analysts, the FDA approved the device six months sooner than expected, it would however, not be available until the spring of 2017.
The MiniMed 670G is the first device that allowed a glucose sensor to communicate with an insulin pump and automatically regulated the insulin flow.
The device which measures glucose levels every five minutes, automatically administers insulin as needed. Patients would still need to instruct the device to deliver extra insulin for meals and notify the device when they exercised - which lowered glucose levels.
"This device will mean peace of mind, in knowing a person will be in normal blood sugar range a great majority of the time," said Derek Rapp, chief executive officer of the Juvenile Diabetes Research Foundation, which has spent $116 million on research in the artificial pancreas field.
Type 1 diabetes patients need to manage their insulin through multiple injections throughout the day or a drug pump that delivered it through a tube.
Their own pancreas does not make insulin, a hormone needed to turn food into energy. They faced increased risks of dangerously high blood-sugar levels, heart disease and many other health problems.
The new MiniMed 670G comprises a drug pump, a sensor that measures blood sugar and a tube for delivering insulin. Sugar levels are monitored every five minutes by the sensor which infuses or withholds insulin as needed.
