Medtronic (NYSE:MDT) today said it won CE Mark approval in the European Union for its MiniMed Duo combination glucose sensor and insulin infusion set.
Touting the device as the world’s 1st to combine continuous glucose monitoring with a body-worn infusion set, Medtronic said it’s planning a launch for MiniMed Duo into the European market as soon as local regulatory authorities give it the green light.
The MiniMed Duo is designed to be used with Medtronic’s MiniMed Veo system, which the Fridley, Minn.-based company said is "the only integrated system with an automatic insulin shut-off mechanism if glucose levels fall too low, providing protection against hypoglycemia (low blood glucose)."
"CGM provides people with diabetes with real-time information about their glucose levels that is invaluable in helping them optimize their diabetes management. However, in the past, many people have been reluctant to use a system that requires them to wear 2 separate devices on their bodies. By integrating a glucose sensor and infusion set into 1 device, MiniMed Duo will make it easier and more comfortable for these patients to adopt and experience the benefits of CGM technology," chief medical officer and vice president of global clinical affairs for diabetes Dr. Francine Kaufman said in prepared remarks.
"For over 30 years, Medtronic has been dedicated to developing world-class technologies to provide better outcomes and simplify diabetes management," added continuous glucose monitoring general manager Greg Meehan. "MiniMed Duo is the latest breakthrough designed in response to the needs of insulin pumpers who don’t want to wear two separate devices on their bodies, addressing one of the most common barriers to CGM technology."