Medtronic fundamentally changed the diabetes management space when it received FDA approval for the MiniMed 670G hybrid closed-loop system back in 2016. The device – dubbed the artificial pancreas has been highly successful used in more than 180,000 people today.
The Dublin-based company wants to reach even more patients and has submitted a request to FDA that could help it accomplish its goal. Last week, the firm announced a PMA submission to the agency requesting for non-adjunctive labeling for the Guardian Sensor 3, as part of the MiniMed 670G system.
Guardian Sensor 3 is a continuous glucose monitoring sensor that controls the automated insulin delivery via Medtronic’s hybrid closed-loop system, the MiniMed 670G system.
Dr. Robert Vigersky, CMO, Global Medical and Clinical Affairs for the Diabetes Group at Medtronic said the reason behind PMA submission is because Medicare requires a non-adjunctive label for sensor reimbursement.
“If non-adjunctive labeling is approved by FDA, the Guardian Sensor 3 can be considered for Medicare reimbursement, which, if granted, could broaden patient access by allowing for Medicare coverage of the world’s first and still the only commercially available hybrid closed loop system,” Vigersky, told MD+DI via email. “With the Medicare coverage, there are two categories of patients who will become eligible to use our sensor - the 20% of individuals with type 1 diabetes (about 150,000 individuals in the U.S.) that are already Medicare age and those who are aging into Medicare (several thousand per year).
Medtronic’s submission for non-adjunctive coverage follows the launch of the enhanced Guardian Link 3 transmitter earlier this year, which the company said improved the patient experience on the system by reducing the number of system alarms by 60% and allowing patients to spend an additional 2.2 hours per day utilizing the SmartGuard technology in Auto Mode, which automatically regulates basal insulin throughout the day and night.