US FDA-approved artificial pancreas first of its kind in global market
The world’s first artificial pancreas, which replicates the functions of a healthy pancreas, has been approved by the US Food and Drug Administration (FDA) for market release. The artificial device, developed by Ireland-based medical technology development company Medtronic Plc, is designed to automatically monitor blood sugar and supply insulin.
The device, called MiniMed 670G, is for patients with Type 1 diabetes who are at least 14 years old. An automatic system will take over part of a diabetic’s daily routine of finger prick tests and insulin injections. Aside from lessening the condition’s need for constant attention, it also offers hope of long-term health improvement through better blood sugar control at inconvenient times, such as at night.
In a recent statement, Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said: “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.”
About the size of a smartphone, the 670G wirelessly connects an insulin pump and a glucose monitor. A sensor that reads just under the skin monitors blood sugar levels every five minutes. A computer algorithm then ensures patients have the right amount of insulin, a hormone that’s needed to turn blood sugar into energy. Medtronic expects the device to win approval outside the US next summer.
The agency’s decision sent shares of rival DexCom Inc. down 4.1% to US$89.84 at the close in New York, the biggest one-day decline since February. DexCom makes continuous glucose monitoring systems used by diabetics, which could be displaced by Medtronic’s device.
According to Medtronic, the MiniMed 670G will not be ready for introduction until the spring of 2017.
Medtronic previously released a system that could shut off if glucose levels fell too low but didn’t automatically deliver the hormone when blood sugar climbed. However, the new device takes on the responsibilities of the human pancreas, which is tasked by the body with producing insulin in precise quantities.
Additional studies on how the system will perform in routine daily life are still required by the FDA. The MiniMed 670G carries risks including blood sugar levels that fall too low or rise too high, as well as skin irritation around the infusion patch.
The 670G was approved based on a study involving 123 patients who safely used the device for three months. It’s specifically designated as unsafe for children age 6 and younger, though Medtronic is testing the system in patients aged seven to 13.
Category: Features, Technology & Devices
