Que Announces FDA Approval For MiniMed™ 780G System

Que announces FDA approval for MiniMed^TM 780G system

I am absolutely thrilled to share with you that today the FDA approved our MiniMed^TM 780G system, featuring our amazing Meal Detection^TM technology.^† I want to personally thank our entire Medtronic community for staying on this journey with us – for the patience, flexibility, and feedback.

We’re proud that our latest system was designed with input from countless customers like you who helped ensure that it addresses key needs. One that everyone had top of mind is the burden around snacks and mealtimes. The ask from our customers? To help simplify this experience.

One of my favorite moments after a long week is sitting down for a meal with my family. We catch up on the happenings of the week and spend time connecting without the distraction of emails and phones. If you’re living with type 1 diabetes, these moments are often interrupted by thoughts of carb counts, insulin dosing, or how your body is feeling.

We want to reduce these interruptions and give back those meaningful moments – pushing diabetes further into the background. And with the MiniMed™ 780G insulin pump system now FDA approved, it helps us deliver on just that!

Watch this video to hear from MiniMed leadership about the approval and directly from individuals who can share their firsthand experience on the system.

Benefits of the MiniMed^TM 780G system

As many of you may know, Medtronic was the first to give you automatic background insulin adjustments. Now the MiniMed™ 780G system will not only adjust insulin delivery every 5 minutes,^§ but it will also deliver correction doses!

What does that look like? Imagine you were enjoying that evening dinner, laughing, and eating, but you forgot to take a meal dose. With the new meal detection technology,* the system will automatically give you a correction dose to help bring you safely back to target. What if you did remember, but underestimated your carb count before the meal?

If the system detects a rapid rise of sugar levels, it automatically§ delivers stronger correction doses, up to every 5 minutes.

The big question: How do you get the MiniMed™ 780G system?

I’m eager to get our latest insulin pump into your hands. I encourage you to visit our website to learn more. I look forward to our journey together as we prepare for all that’s to come.

Warmly,
Que

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Important Safety Information: MiniMed^TM 780G system with SmartGuard^TM technology with Guardian^TM 4 sensor

The MiniMed^TM 780G system is intended for the continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable rates for the management of type 1 diabetes mellitus in persons 7 years of age and older, and of type 2 diabetes mellitus in persons 18 years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed^TM780G system includes SmartGuard^TM technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed^TM 780G system consists of the following devices: MiniMed^TM 780G Insulin Pump, the Guardian™ 4 Transmitter, the Guardian™ 4 Sensor, One-press serter, the Accu-Chek^TMGuide Link blood glucose meter, and the Accu-Chek^TMGuide Test Strips. The system requires a prescription from a healthcare professional.

The Guardian^TM 4 Sensor is intended for use with the MiniMed^TM 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian^TM(4) sensor is indicated for up to seven days of continuous use.

The Guardian^TM 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed^TM 780G is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian^TM 4 sensor. The Guardian™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian^TM 4 sensor in the abdomen or other body sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.

WARNING: Do not use the SmartGuard^TM feature for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in the SmartGuard^TM feature.

WARNING: Do not use the MiniMed^TM 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed^TM 780G system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard^TM feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed^TM 780G system has not been studied in pregnant women or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult https://www.minimed.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.minimed.com/resources