FDA Approves Medtronic’s MiniMed 670G System: First Hybrid Closed Loop Insulin Delivery System

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Medtronic’s MiniMed 670G System

Medtronic has received U.S. FDA approval of its MiniMed 670G system – the first Hybrid Closed Loop insulin delivery system approved anywhere in the world. Featuring the company’s most advanced algorithm – SmartGuard(TM) HCL – the system is the latest innovation in Medtronic’s phased approach toward developing a fully automated, closed loop system. Medtronic is committed to simplifying and improving diabetes management through the advancement of smart algorithms that achieve greater glucose control with reduced patient input. Through SmartGuard HCL, the system builds on Medtronic’s industry leading algorithms to offer therapy customization so patients and providers can choose from increasing levels of automation that best fit their diabetes management needs.

The MiniMed 670G system features the Guardian Sensor, Medtronic’s newest and most advanced glucose sensor with enhanced accuracy and performance, and a longer 7-day life. The Guardian Sensor, the first and only sensor approved by the FDA to control a hybrid closed loop system, incorporates diagnostic technology that continuously monitors sensor health. Driven by the SmartGuard HCL, the system delivers a variable rate of insulin 24 hours a day based on the personalized needs of the patient, maximizing the time glucose levels are within the target range. It is designed to learn what an individual’s insulin needs are and to take action to minimize both high and low glucose levels. As a result, the system requires minimal input – patients only need to enter mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor.

The system is approved for the treatment of people with type 1 diabetes fourteen years of age and older with ongoing studies to expand the indication to additional patient populations.

Medtronic will begin commercial release of the MiniMed 670G system in the spring of 2017 with system availability increasing over time. This timeline ensures payer coverage, market and manufacturing readiness, as well as appropriate training of employees, clinicians, educators and patients on the new system. As the company moves toward initial commercial release and subsequently to full production, users of the MiniMed 630G system will be eligible for a Priority Access Program to the MiniMed 670G system as their experience with our newest hardware platform will facilitate an optimal transition. Regulatory approval of the MiniMed 670G is expected outside of the U.S. in the summer of 2017. More details can be found at http://www.medtronicdiabetes.com/products/priority-access.

 

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