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|Medtronic Receives CE Mark for MiniMed(TM) 670G Hybrid Closed Loop System|
(GLOBE NEWSWIRE via COMTEX) --DUBLIN - June 25, 2018 - Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for the MiniMed(TM) 670G hybrid closed loop system - the first and only system to automate and personalize the delivery of basal insulin 24 hours a day1. The system is CE Mark approved for the treatment of people with type 1 diabetes 7 years of age and older with ongoing studies to expand the indication to additional patient populations.
"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," said Alejandro Galindo, president of the Advanced Insulin Management division within the Diabetes Group at Medtronic. "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."
The company's most advanced SmartGuard(TM) technology and most accurate2 continuous glucose monitor (CGM) - the Guardian(TM) Sensor 3 - work together to self-adjust basal insulin delivery to offer protection against both highs and lows, helping to improve Time in Range (the percentage of time spent in the optimal glycemic range of 70-180 mg/dL or 3.9-10 mmol/L)3,4. SmartGuard technology is the only smart algorithm that can adapt to fluctuating glucose levels and automatically self-adjust background insulin delivery to stabilize them. This advanced algorithm mimics some of the functions of a healthy pancreas and is the only technology in the world that proactively drives an increase in Time in Range - addressing both highs and lows. The system also exclusively features the CONTOUR®NEXT LINK 2.4 blood glucose monitoring system from Ascensia Diabetes Care.
"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," said Pratik Choudhary, M.D., senior lecturer and consultant in diabetes at 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."
Medtronic will begin commercial release of the MiniMed 670G system in select countries in Europe in the autumn of 2018, subject to local regulatory requirements.
Time in Range
About the Diabetes Group at Medtronic (www.medtronicdiabetes.com)
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Ascensia Diabetes Care and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.
For detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events, please consult the device manual. For further information, contact your local Medtronic representative.
1 Iturralde E, et all. The Diabetes Educator. 2017; 43(2):223 - 232.
2 Christiansen M, et al. Diabetes Technol Ther. 2017; 19(9): 1-11.
3 Bergenstal, R. M. et al. Jama. 2016; 316 (16): 1407 - 1408.
4 Garg SK et al. Diabetes Technol Ther. 2017 Mar;19(3):155-163.
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Source: Medtronic plc via Globenewswire