Starting MiniMed 670G System Customer Training Phase

Starting MiniMed 670G System Customer Training Phase | Medtronic

I’m pleased to announce the start of our Customer Training Phase for the MiniMed 670G system.

During this phase, we’ll focus on on-boarding a small group of Priority Access Program participants at a select number of healthcare provider sites across the country. These sites will reflect diversity in terms of practice type, size, experience with Medtronic therapies, and geographic location so we can ensure an optimal experience for everyone who transitions to this new therapy.

This phase will allow us to validate our training and on-boarding program to ensure that it is not only robust, but that we have created the best patient experience. We will conduct the training phase and fine-tune our on-boarding program over the course of a few months before we initiate a full commercial launch.

MiniMed 670G System Launch Timeline

MiniMed 670G System Launch Timeline | Medtronic

All select Priority Access Program participants who will participate in this training phase will be contacted by a Medtronic representative over the next few weeks with more details.

We are thrilled with the overwhelming response from the diabetes community and the excitement around our hybrid closed loop system. We are confident that this systematic and deliberate rollout will provide the best experience for everyone transitioning to our MiniMed 670G system.

We thank you for your continued loyalty to Medtronic!

Important Safety Information

The Medtronic MiniMed 670G system requires a prescription and 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, fourteen 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 670G System includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.

The Guardian Sensor (3) is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the Guardian Sensor (3).

WARNING: Medtronic performed an evaluation of the MiniMed 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Do not use the serter on products other than the Enlite sensor or Guardian Sensor (3). Medtronic cannot guarantee the safety or efficacy of this product if used with other products. The reservoir is contraindicated for the infusion of blood or blood products. Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products. Insulin pump therapy is not recommended for those who are unwilling to perform at least four blood glucose tests per day. As insulin pumps use rapid acting insulin only, BG testing is required to help identify rapid glycemic deterioration due to insulin infusion occlusion, infusion site problems, insulin stability issues, user error, or a combination of these. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.

The safety of the 670G system has not been studied in people with impaired kidney function. Please let your healthcare professional know if you have kidney disease so you and your healthcare professional can determine if the potential benefits of using the system outweigh the risks. The safety of the 670G system has not been studied in pregnant women, people with type 2 diabetes, or in people using other anti-hyperglycemic therapies apart from insulin. Please let your healthcare professional know if any of these conditions apply to you so you and your healthcare professional can determine if the potential benefits of using the system outweigh the risks.

For complete safety information, please consult the appropriate User Guide.

*The CONTOUR®NEXT LINK 2.4 Meter is used with the MiniMed 630G system. The CONTOUR®NEXT LINK Meter is used with the MiniMed 530G system.

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