Preparing for MiniMed 670G System Launch

Preparing for MiniMed 670G System Launch

In September, we announced an incredibly exciting milestone that sent waves through the healthcare industry.

The excitement and anticipation that we’ve seen in response to the FDA approval of the MiniMed 670G system is gratifying, both on a personal and professional level.

We have the unique opportunity and privilege of introducing the first ever hybrid closed loop (HCL) system, which features our most advanced SmartGuard HCL technology and new Guardian Sensor 3. As we prepare for the MiniMed 670G system launch, we need to ensure we leverage this once-in-a-lifetime moment in diabetes history to deliver an optimal therapy experience to customers.

Until January 31, MiniMed 630G system users can sign up to be first in line to receive the new system for as low as $0 (exclusions apply) as it becomes available through our Priority Access program. Experience on the new pump platform will help facilitate an optimal transition.

To ensure that we onboard customers the right way, new MiniMed 670G system users will onboard through a dedicated team of StartRight employees, and will experience a unique training program tailored to their needs.

We are also preparing for commercial release in the spring of 2017, which includes ensuring adequate payer coverage, market and manufacturing readiness, and developing the proper training tools/programs for employees, clinicians, educators, and customers.

We are incredibly excited to be able to offer this life-changing innovation to the diabetes community.

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.

WARNING: Do not use the Suspend on low feature to prevent or treat low glucose. Always confirm your sensor glucose reading using your BG meter, and follow the instructions of your healthcare professional to treat low glucose. Using Suspend on low alone to prevent or treat low glucose may result in prolonged hypoglycemia.

WARNING: Do not use Auto Mode for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in Auto Mode. Therefore, Auto Mode could deliver too much insulin. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you resume Auto Mode.

Contraindications

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.

General Warnings

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.

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