Medtronic wins FDA approval for new extended-wear infusion set

Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set.

The goal of the study is to collect clinical data that supports the use of the device for up to seven days, more than twice the amount of time any infusion set can currently be used, according to a news release.

The 150-patient, non-randomized trial is slated to involve subjects between 18 and 80 years old with Type 1 diabetes on insulin pump therapy. The infusion sets allow people on insulin pump therapy to deliver insulin under the skin. Current sets are changed every two to three days, according to the release.

Users of Fridley, Minn.-based Medtronic’s MiniMed 670G system will wear each infusion set for up to seven days in the trial.

The changing of the infusion set and glucose monitor would be coordinated after seven days with Medtronic’s new device. Dani Labriola, whose son uses the MiniMed 670G system to manage his diabetes, highlighted the convenience of Medtronic’s proposed device in prepared remarks.

“I would love for my son to spend less time thinking about his diabetes and more time living his best life,” Labriola said. “Changing his set once per week instead of two to three times would take away some of that burden and would make a difficult disease easier.”

“There have been significant advances made in the three-plus decades with insulin pumps and continuous glucose monitoring,” added Dr. Satish Garg of the University of Colorado’s Barbara Davis Center. “However, we are still stuck with having patients change the insulin delivery sets every two to three days whereas most CGMs are now used longer. It is time for an infusion set to extend wear to a week and beyond. This is long overdue and will likely improve quality of life for patients on insulin pumps, and many more patients may accept insulin pump as an option.”