Medtronic plc announced CE (Conformité Européenne) Mark approval in Europe to expand the indications of its MiniMed™ 780G system. The system is now approved for use by individuals aged 2 years and older, during pregnancy, and for type 2 insulin-requiring diabetes.
This expanded indication is based on published clinical data demonstrating the system's safety and efficacy in these broader populations. For young children with type 1 diabetes, data from the LENNY trial showed a 0.6% lower HbA1C and 9.9% higher time in range.
For pregnant women with type 1 diabetes, a European study showed an average Pregnancy Time in Range (TIRp) of 66.5%, a significant improvement over traditional therapy. In type 2 diabetes, a pivotal trial resulted in a 0.7% reduction in HbA1c and an increase in TIR to 80%. This significantly broadens the market for Medtronic's advanced automated insulin delivery system.
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