Important Update on MiniMed 670G Availability and the Priority Access Program

Last fall we announced the FDA approval of the world’s first hybrid closed loop system and it was one of the proudest days of my career. After 35 years of innovation, we’re thrilled to make this revolutionary technology a reality. The MiniMed 670G® system is the most advanced insulin pump and sensor system that is personalized to your life and your diabetes. The response from the diabetes community has been incredibly touching and we thank you for all of your feedback along the way.

Over the last few months we’ve been preparing our manufacturing, training and education – key steps to bringing the product to market. We know that anticipation for the new system is incredibly high and have been working as quickly as possible. But we also take our responsibility as an innovation leader seriously and are committed to taking the time needed to ensure that everyone has the best possible experience on this new system.

Today we’re here to share an important update on the rollout of the MiniMed 670G system.

Priority Access Program

Those who purchased the MiniMed 630G system between August 10th of 2016 and April 28 of 2017 may be eligible to participate in the Priority Access program. These people have the opportunity to be among the first in line to upgrade to the MiniMed 670G system. The reason is that we believe those already using our newest pump platform will experience the easiest and quickest transition to the new system.


First Step: The Customer Training Phase

As we prepare to make the MiniMed 670G system available to everyone, we’ll start out with a small group of Priority Access program participants at a select number of people with diabetes and healthcare provider sites. This Customer Training Phase will allow us to validate the training and onboarding program we’ve designed specifically for this first-of-its-kind product. We’re calling this the “Customer Training Phase” and it will include those who enrolled in the Priority Access program.

If you are part of this Customer Training Phase, we’ll reach out to you within the next couple of weeks via text and/or email to ensure we have all the necessary documentation to process your order. Once we receive your prescription and verify insurance coverage, we will ship your new system to you. You’ll be contacted shortly after that to schedule training.

Full Priority Access Program Rollout

The rollout to the rest of the Priority Access program participants will begin in June. This gives us time to refine our training and education before we make it more broadly available.

If you are part of the Priority Access program, but not in the Customer Training Phase, you’ll receive a text message with instructions on how to place your order as early as June. We expect it will take several weeks to process the paperwork, ship orders and train all of those in the Priority Access program.

Commercial Availability 

Those who order the MiniMed 670G system after April 28 will not be part of the Priority Access program. Because it’s important that we keep our commitments to those who enrolled in Priority Access, this means it may take us several months before we can place your order. We appreciate your patience as there are a lot of people who are part of Priority Access and it will take some time to ship their systems and ensure they receive the necessary training.

After Priority Access ends in April, you do not have to start on MiniMed 630G® system to transition to the MiniMed 670G system. We will offer similar pathway programs as we have done in the past. More information will be shared this summer.

Insurance Coverage

Our team has been working hard with insurance companies nationwide to ensure broad access. This is going very well and we anticipate coverage will increase over time. Please know we’re committed to working with those interested in transitioning to this system as well as their insurance companies to ensure access to this transformative therapy.

 

Thank you all for your patience and enthusiasm throughout this process. We’re really excited to bring the MiniMed 670G system to you! But we know that, since it is the world’s first hybrid closed loop system, what’s most important is that we take the time to make sure each and every one of you has the best experience possible.

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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