On Wednesday, the FDA approved Medtronic’s hybrid closed-loop system, the world’s first “artificial pancreas.” The agency nod comes months ahead of the spring approval that the company had been expecting.
The MiniMed 670G hybrid closed-loop system is the first FDA-approved device that continuously measures glucose levels and delivers the appropriate dose of basal insulin, according to an FDA statement. It is indicated for people aged 14 or older with Type 1 diabetes and is intended to regulate insulin levels with “little to no input” from the patient, the FDA said in the statement.
“This first-of-its-kind technology can provide people with Type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in the statement.
The system comprises Medtronic’s MiniMed 670G insulin pump that is strapped to the body, an infusion patch that delivers insulin via catheter from the pump and a sensor that measures glucose levels under the skin and can be worn for 7 days at a time. While the device regulates basal, or background, insulin, users must still manually request bolus insulin at mealtimes.
The approval comes just three months after Medtronic submitted the system for FDA review. The agency assessed data from a clinical trial in which 123 patients with Type 1 diabetes used the system’s hybrid closed-loop feature as often as possible during a three-month period. The trial showed the device to be safe for use in those 14 and older, reporting no serious adverse events, the FDA said. The system will hit the market in spring next year.
While Medtronic has bested its competition in the race to get an artificial pancreas approved, the devicemaker counts it as another step toward a fully automated, closed-loop system, it said in a statement.