Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its MiniMed 670G hybrid closed-loop insulin management system for Type I diabetes patients age 7 and older.
Fridley, Minn.-based Medtronic said it has clinical programs under way to back expanded indications for the device, which is designed to continuously monitor regulate basal insulin delivery using the company’s SmartGuard algorithm and Guardian Sensor 3. The MiniMed 670G also uses Ascensia Diabetes Care‘s ContourNext Link 2.4 blood glucose monitor. The aim is to keep diabetic patients in the optimal glycemic range of 70-180 mg/dL or 3.9-10 mmol/L.
Medtronic said it plans to have MiniMed 670G on the market in “select” European countries in the autumn of 2018.
“We’re proud to introduce our most advanced SmartGuard Auto Mode algorithm outside of the United States, which not only helps to prevent lows but works to drive time in range – a most important measure of the effect of diabetes management on a patient’s glucose levels – by decreasing time in hyperglycemia,” advanced insulin management president Alejandro Galindo said in prepared remarks. “The MiniMed 670G system advances our ability to automatically suspend and resume insulin delivery to the next level by automating self-adjusting basal insulin delivery every 5 minutes based on sensor glucose values – providing the most advanced algorithm available to deliver leading clinical outcomes.”
“We have seen that this innovation offers great promise for better glucose control and improved quality of life for those living with Type 1 diabetes,” added Dr. Pratik Choudhary of King’s College London. “The ability of the MiniMed 670G system to stabilize glucose levels automatically is an important advancement, and I look forward to introducing it to my patients in Europe.”