Medtronic Expands MiniMed 780G System Indications in Europe, Targets U.S. Market

Medtronic, a leading medical device company, has received an expanded CE mark for its MiniMed 780G automated insulin delivery system in Europe. The new indication allows for broader use of the system, including in patients with Type 2 diabetes, during pregnancy, and in children as young as two years old.

Expanded Indications and Clinical Data

The expanded CE mark for the MiniMed 780G system is supported by robust clinical data. A single-arm, pivotal trial involving 95 people with Type 2 diabetes demonstrated significant improvements in glycemic control. Published in Diabetes Technology and Therapeutics, the study reported a 0.7% reduction in hemoglobin A1c from a baseline of 7.9%, and an increase in time in range from 72% to 80%.

For pediatric use, a randomized controlled trial published in the Lancet Diabetes & Endocrinology showed the system's safety and effectiveness in children ages two to six with Type 1 diabetes. Additionally, an open-label randomized controlled trial evaluated the system's use during pregnancy, finding improved overnight time in target range, although overall time in range was not significantly affected.

U.S. Market Expansion Plans

Medtronic is actively pursuing similar label expansions in the United States. The company has submitted an application to the FDA for the use of the MiniMed 780G system in people with Type 2 diabetes. Clinical trials are also underway to assess the system's efficacy in children aged two to six years old in the U.S. market.

Industry Trends and Competition

The expansion of automated insulin delivery systems to Type 2 diabetes patients represents a growing trend in the industry. Competitors such as Insulet and Tandem Diabetes Care have already received FDA clearance for expanded labels for their AID systems in Type 2 diabetes management.

Medtronic's CEO, Geoff Martha, reported strong growth in the company's diabetes segment, with revenue increasing by nearly 12% year over year to $647 million. This growth is attributed to the expanding MiniMed 780G installed base in both U.S. and international markets. As Medtronic prepares to spin out its diabetes unit into a separate public company, these developments are crucial for maintaining market position and driving innovation in diabetes care technology.