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Important Product Safety InformationAlert: Product and Recall Notices

Leading innovation.
For more than 30 years, Medtronic has committed to transforming
diabetes care.

EXCITING NEWS icon

EXCITING NEWS!


We’ve submitted the MiniMed™ 780G and Guardian™ 4 sensor to the FDA. This submission is the next step in our goal to reduce fingersticks and bring you an advanced algorithm with auto correction bolus.


Please keep in mind that the FDA has a period for review. This process can take some time and we will provide updates when available.

Our goal for the future is aimed at developing technologies that are:

Simpler

Simplify diabetes management

Smaller

Create more discreet products

Smarter

Develop predictive analytics that adapt to individual needs

A HISTORY OF FIRSTS


2020
 1st real-time CGM + smart<sup>^</sup> pen (real-time MDI decision support) 1st real-time CGM + smart^ pen (real-time MDI decision support)
2020
 1st automated insulin pump system approved for ages 2 and up 1st automated§ insulin pump system approved for ages 2 and up (MiniMed™ 770G system)
2018
 1st standalone Smart<sup>*</sup> CGM with predictive alerts 1st stand-alone Smart* CGM with predictive alerts
2017
 1st system to automatically adjust background insulin 1st system to automatically adjust background insulin
2016
 InPen launched and FDA clearance issued InPen launched and FDA clearance issued†
2015
 1st technology to help reduce lows 1st technology to help reduce lows**
2009
 1st technology to help reduce severe lows 1st technology to help reduce severe lows*
2006
 1st system to integrate pump & CGM 1st system to integrate pump & CGM
^ Smart insulin pens connect to a mobile app to provide dosing calculations, reminders and CGM system integration.

§ Refers to SmartGuardTM Auto Mode. Some user interaction required. Individual results may vary.

*Smart CGM predicts future high and low sensor glucose events up to 60 minutes in advance.

† Medtronic acquired Companion Medical in 2020.

** System not approved in the US.

PLANNED FUTURE PRODUCT INNOVATIONS


All referenced product innovations are in development or still being designed. Such innovations are not FDA-approved and will require FDA review prior to such approval.


PLANNED FUTURE PRODUCT INNOVATIONS

† Investigational. Not approved by the FDA for any use and not commercially available in the US.
†† In development. Potential future technology. Not approved by the FDA and not commercially available. The innovations described above are all currently in development. Features and performances of future technologies may vary. Access to future technologies are contingent upon regulatory approval. Approval timelines are subject to the regulatory process of individual countries and regions and not guaranteed.
∆ Software Upgrade Terms and Conditions:
  • This program allows MiniMed™ 770G system customers a software upgrade at no charge through. October 27, 2022.
  • Software upgrade process is subject to change and may result in healthcare provider office visit and may result in out-of-pockets expenses such as co-pay, depending on insurance coverage.
  • MiniMed™ pumps and software have certain labeling restrictions that may exclude certain populations, including age and type of diabetes. We recommend you consult your healthcare provider regarding your eligibility to receive the software upgrade based on the labeling of the upgrade, which may differ from the labeling of the MiniMed™ 770G pump.
  • This program applies to the insulin pump software only. Continuous Glucose Monitor products and consumables are not included in this offer.
  • A valid prescription will be required for this software upgrade. All participants should consult their healthcare provider for all therapy related decisions.
  • Warranty dates do not reset. The replacement warranty date of an insulin pump upgraded with the software will remain the same as the replacement warranty date of the initial pump purchased.
  • Insurance coverage and plan design varies and may impact the ability to upgrade. Coverage is contingent upon your health insurance medical policy guidelines. Restrictions and medical necessity requirements may apply.
  • Program terms and conditions are subject to change at any time and without notice. Other restrictions may apply.

Important Safety Information: MiniMed™ 770G System With SmartGuard™ Technology
The MiniMed™ 770G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons two years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 770G System includes SmartGuard™ technology, which can be programmed to automatically adjust delivery of basal insulin 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™ 770G System consists of the following devices: MiniMed™ 770G Insulin Pump, the Guardian™ Link (3) Transmitter, the Guardian™ Sensor (3), one-press serter, the Accu-Chek® Guide Link blood glucose meter, and the Accu-Chek® Guide Test Strips. The system requires a prescription.The Guardian™ Sensor (3) has not been evaluated and is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ Sensor (3).

All therapy adjustments should be based on measurements obtained using the Accu-Chek® Guide Link blood glucose meter and not on values provided by the Guardian™ Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the Accu-Chek® Guide Link blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an Alternative Site. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise.

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

WARNING: Do not use the MiniMed™ 770G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed™ 770G system.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed™ 770G system has not been studied in pregnant women. 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.medtronicdiabetes.com/important-safety-information#minimed-770g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library


Important Safety Information: InPen™

The InPen requires a prescription. It is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.

For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.

For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.

For additional product and important safety considerations, see User Guide and http://bit.ly/InPenSafety.

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