Medtronic reports encouraging data for next-generation insulin pump

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.

In a report released Monday, Marcus wrote that the new information offered "a boost to the system's credibility, but in our view, doesn't change the narrative much in the U.S. given the uncertainty from the FDA warning letter at a time when competitors are taking share and forging ahead."

The new updates were discussed at the ADA global meeting in New Orleans last weekend. The event is a forum for companies and doctors to provide updates on diabetes research, treatment and care.

Six months after the warning letter was issued, Medtronic is working with the FDA to resolve issues the agency raised. Medtronic submitted materials to the FDA for pre-market approval of the 780G in early 2021.

"Discussions are ongoing as we continue to work through the commitments, and substantial progress has been made," said Pamela Reese, a spokeswoman for Medtronic.

Diabetes care is the company's smallest business division. For its most recent quarter, its sales accounted for 7.4% of the company's total revenue.

Sales in Medtronic's U.S. diabetes unit dropped 27.3% in its fiscal 2022 fourth quarter, which ended April 29, "given the absence of new product approvals," the company said at the time.

In March, Medtronic named Honeywell executive Que Dallara to lead the diabetes division. Medtronic's operational headquarters is in Fridley.