Medtronic says it has promising data on the effectiveness of its next-generation insulin pump from patients in Europe and Chile.
The MiniMed 780G insulin pump, which was cleared in 2020 for use in Europe, is not yet available in the U.S.
Current standards from the American Diabetes Association (ADA) recommend that diabetes patients be within the recommended glucose guidelines at least 70% of the time, a measure called "time in range." Medtronic's newest data show that patients currently using the 780G, which offers continuous glucose monitoring, are consistently exceeding that range.
"The pump is delivering insulin every five minutes," said Dr. Robert Vigersky, chief medical officer for Medtronic's diabetes business. "It's a really advanced algorithm."
Medtronic's diabetes business has faced a number of challenges recently. The U.S. Food and Drug Administration issued a warning letter in mid-December raising concerns over how the company's California-based diabetes unit had handled complaints, assessed product risks and managed recalls for some insulin pump devices.
Analysts began to worry those issues may have delayed FDA approval for the 780G.
The 780G is available in more than 40 countries.
Robbie Marcus, an analyst with J.P. Morgan who follows Medtronic, said that while the 780G data — made public late last week — are encouraging, he's still concerned about the pump's regulatory status in the U.S.
