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Medtronic obtains CE mark for the MiniMed system with Simplera Sync glucose monitor.

Medtronic has secured CE mark approval for the MiniMed 780G system, now integrated with Simplera Sync. This disposable, all-in-one continuous glucose monitor (CGM) eliminates the need for fingersticks or overtape. The Simplera Sync stands out with its two-step insertion process and is notably half the size of Medtronic’s previous sensors.

The MiniMed 780G system with Simplera Sync sensor will be available in Europe via limited release in spring 2024. Medtronic will begin the phased commercial launch in Europe in the summer of 2024. Today, the MiniMed 780G system can be used with the Guardian 4 sensor.

The MiniMed 780G system is Medtronic’s most advanced insulin delivery system, automatically adjusting and correcting glucose levels every five minutes. It’s the world’s only system with a Meal Detection feature that is designed to reduce post-meal hyperglycaemia when users occasionally forget to give themselves insulin or underestimate the number of carbs in their snacks or meal. The system, which is available with the world’s only 7-day infusion set, also features one of the lowest glucose target settings (as low as 100 mg/dL) of any automated insulin delivery system. With this “treat to target” approach, the system more closely mirrors the glucose levels of someone not living with diabetes. With both Simplera Sync sensor and the Guardian 4 sensor, no fingersticks are required.

Robert Vigersky, M.D., chief medical officer, Medtronic Diabetes, professor of medicine, Uniformed Services University of the Health Sciences, said: “A challenging aspect of living with diabetes is counting carbohydrates and dosing the right amount of insulin before consuming snacks and meals. Many people underestimate their carbs, which can lead to high blood sugars (hyperglycaemia). Prolonged hyperglycaemia can lead to serious health problems impacting the eyes, major organs, and even cognitive function, which is particularly concerning in developing children. With its responsive algorithm, the MiniMed 780G system can help people living with diabetes even when they occasionally forget to bolus or undercount their carbs. The system takes on more of the work involved in diabetes management and helps alleviate mental burden.”

Que Dallara, EVP and president, Medtronic Diabetes, added: “We’re incredibly proud that the MiniMed 780G system continues to be the most widely used automated insulin delivery system in Europe since we launched it in 2020. Real-world data on over 100,000 users on the system across many geographies and cultures shows that when using recommended settings, the system is delivering an average Time in Range of nearly 80%, raising the bar on what ‘good’ looks like. With the introduction of Simplera Sync sensor, we’re able to offer the proven benefits of our MiniMed 780G system with our newest and most comfortable sensor that can be applied in under 10 seconds.”

The MiniMed 780G system with Simplera Sync sensor is indicated for ages 7+ and compatible with iOS and Android. Simplera Sync sensor is not approved by the FDA and is limited to investigational use in the U.S.

© Medtronic Plc

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