Medtronic has been awarded Food and Drug Administration (FDA) approval for its MiniMed® 670G system, an ‘artificial pancreas’ device that automatically delivers the right dose of insulin to patients with type 1 diabetes. The cellphone-sized device features the Guardian® Sensor, delivering 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.
Insulin pumps are currently used by more than a third of U.S. patients with type 1 diabetes, but they require manual adjustment to administer the required insulin dose. The MiniMed 630G system learns 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 is expected to begin commercial release of the MiniMed 670G system in the spring of 2017 with system availability increasing over time.
“The FDA approval of the world’s first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes,” said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic. “We appreciate the unprecedented speed by which the agency approved our PMA submission to help bring this advanced insulin pump therapy so quickly to U.S. patients living with this challenging disease. We are committed to preparing for commercial launch as quickly as possible while ensuring we provide the most successful rollout of this novel therapy.”
