MiniMed 670G System Launches in the United States

I am pleased to share that today we announced the commercial launch of the MiniMed 670G system. Since earlier- than-expected FDA approval in September 2016, we have been working to ensure payer coverage, market and manufacturing readiness, as well as appropriate training of employees, clinicians, educators and patients on the new system.

We also initiated our Customer Training Phase, which validated our robust training and onboarding program among a small group of Priority Access Program participants. This initial rollout allowed us the opportunity to review our protocols and ensure an optimal experience for those transitioning to the new system. Real-world use of the system in the Customer Training Phase has demonstrated improved outcomes across several important areas including greater Time in Range (74 percent) and greater median time in Auto Mode (92 percent).1 Real-world use of the Guardian Sensor 3 also demonstrates continued strong performance and reliability of the company’s most accurate sensor to date with a MARD of 10.56 percent against BG2 – confirming why it’s the only continuous glucose monitor trusted and approved by the FDA to power a hybrid closed loop system.  Following excellent feedback on system performance, clinical outcomes and user experience in the Customer Training Phase – including a 94 percent overall satisfaction rate with the training and onboarding – the company has made the decision to initiate a broader commercial launch.

Medtronic is now onboarding the rest of those enrolled in the Priority Access Program who signed up to be first in line to receive the system upon commercial launch. In parallel, we are now taking new orders from interested customers who want to be next in line to receive the system after Priority Access orders are fulfilled. To be placed in the order queue, customers can call the Medtronic HelpLine at 1.800.646.4633 or complete an online form at http://bit.ly/2qLNCoA.

We are excited to launch the world’s first Hybrid Closed Loop system and our number one priority will continue to be providing the best experience for everyone transitioning to our MiniMed 670G system.  We appreciate your patience as we meet the needs of our many customers. Thank you for your continued loyalty to Medtronic!

 

1 Data on file.
2 Results compared with capillary blood glucose results using a blood glucose meter. Results compared to YSI (Yellow Springs Instruments, Yellow Springs, OH) typically yield results that are 1-1.5 percentage points lower.
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).

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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