Medtronic Expands MiniMed 780G System Indications in Europe, Eyes U.S. Approval

Medtronic, a leading medical technology 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 CE mark expansion for the MiniMed 780G system is supported by robust clinical evidence. 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 showed 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 confirmed the safety and effectiveness of the 780G system in children aged two to six with Type 1 diabetes. Additionally, an open-label randomized controlled trial evaluated the system's use during pregnancy, showing improved overnight time in target range, although overall time in range remained unchanged.

U.S. Regulatory Progress and Market Impact

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

The expansion of automated insulin delivery systems to Type 2 diabetes patients represents a growing trend in the industry. Competitors Insulet and Tandem Diabetes Care have already received FDA clearance for similar expanded indications in the past year.

Medtronic's Diabetes Business Performance

The expanded indications come at a crucial time for Medtronic's diabetes segment. CEO Geoff Martha reported in a recent earnings call that the diabetes segment revenue grew by nearly 12% year over year to $647 million. This growth is largely attributed to the increasing adoption of the MiniMed 780G system in both U.S. and international markets.

As Medtronic continues to focus on turning around its diabetes business, the company has announced plans to spin out the unit into a separate, public company. The expanded indications and positive clinical data for the MiniMed 780G system are likely to play a significant role in this strategic move.