Medtronic (MDT) Wins CE Mark for MiniMed 780G With Simplera Sync

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Medtronic plc MDT recently achieved the CE Mark for the MiniMed 780G system with Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM) that does not require any fingersticks or over tape. The newest sensor is half the size of previous Medtronic sensors and features an improved user experience with a simple, two-step insertion process.

The latest development will significantly boost the company’s Diabetes business. The MiniMed 780G system with the Simplera Sync sensor will be available in Europe via a limited release in the spring of 2024, followed by an expected phased commercial launch in the summer of 2024.

Significance of Medtronic’s AID System

A challenging aspect of diabetes management lies in counting carbohydrates and dosing the right amount of insulin before consuming snacks and meals. Many people tend to underestimate their carbs, which can lead to high blood sugar (hyperglycemia). Prolonged hyperglycemia can potentially cause serious health problems impacting the eyes, major organs and even cognitive function, which is particularly concerning in developing children.

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Medtronic's most advanced insulin delivery system automatically adjusts and corrects glucose levels every five minutes and features meal detection technology. With its responsive algorithm, the MiniMed 780G system can help users reduce post-meal hyperglycemia even when they occasionally forget to bolus or undercount their carbs.

The system, which is available with the world's only seven-day infusion set, also features one of the lowest glucose target settings of any automated insulin delivery (AID) system. With this "treat to target" approach, the system more closely mirrors the glucose levels of someone not living with diabetes. The MiniMed 780G system can also presently be used with the Guardian 4 sensor.

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Medtronic takes pride that the MiniMed 780G system continues to be the most widely used AID system in Europe since its launch in 2020.  With the introduction of the Simplera Sync sensor, the company is now able to extend the proven benefits of the MiniMed 780G system with its newest and most comfortable sensor that can be applied in under 10 seconds.

The Simplera Sync sensor leverages Medtronic's advanced AID algorithm as part of its MiniMed 780G system while having a similar look and feel as the Simplera CGM. The MiniMed 780G system with the Simplera Sync sensor is indicated for ages seven and above and is compatible with iOS and Android. In the United States, the Simplera Sync sensor is not approved by the FDA and is limited to investigational use.