Medtronic: In the lead
Medtronic stepped ahead of the pack last September when it won FDA approval for its MiniMed 670G artificial pancreas hybrid closed loop system, making it the 1st system of its kind to win clearance globally. While the system isn’t a stand-alone artificial pancreas, as it requires entry of carbohydrates and a baseline blood sample, it is a significant step toward the development of a fully capable closed-loop solution.
The MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients with diabetes, measuring blood glucose every 5 minutes and automatically administering or withholding insulin.
The system from medical device giant – based in Ireland but with operational headquarters in Minnesota – includes a body-attached sensor to track glucose levels under the skin, a worn insulin pump and an infusion patch connected to the pump with a catheter to deliver insulin. The device will automatically adjust insulin levels, but requires manual entry of carbohydrates consumed and approval for bolus correction recommendations.
The device features Medtronic’s SmartGuard algorithm, which the company says is the 1st step on its phased approach towards developing a fully automated, closed-loop system. The MiniMed 670G also includes the company’s Guardian Sensor, a glucose sensor with a 7-day lifespan and baked in diagnostic technology to constantly monitor the sensor’s health. The system is designed to “learn” an individual’s insulin needs and take action to minimize both high and low glucose levels.
The system won approval for the treatment of individuals with type 1 diabetes ages 14 and older, with ongoing studies looking to expand the indication to additional patient populations. Medtronic said it is planning a commercial release in the spring of 2017, with “system availability increasing over time.”
Regulatory approval of the system outside the U.S. is expected by the summer of 2017, Medtronic said.