Medtronic submits 'artificial pancreas' for FDA approval

Medtronic's closed loop system

As promised, Medtronic ($MDT) has filed for premarket approval for its hybrid closed-loop system, which measures diabetics' blood glucose levels in real time and automatically adjusts the amount of insulin it delivers.

Medtronic anticipates approval in the spring next year. If approved, it will be the world's first "artificial pancreas." The system comprises Medtronic's MiniMed 670G insulin pump, fourth-generation glucose monitors and a control algorithm. The sensors are worn for 7 days before they need recharging, while the insulin pump needs to be refilled every three days, Bloomberg reported.

The submission is based on pivotal data, which Medtronic presented to the American Diabetes Association conference earlier this month. The data showed that the system helped to lower A1c levels and maintain more consistent blood glucose sensor values in 124 patients with Type 1 diabetes. No adverse events were reported in the study, which spanned 12,389 patient days. At the end of the study, most of the patients chose to join the continued-access program for the device.

A separate study involving 12 adults and 16 adolescents showed that overnight use of the closed-loop system reduced the time adults needed to get to their target glucose range and decreased nocturnal hypoglycemia for the adolescents.

Medtronic is leading the race to get an artificial pancreas to market, but the device giant isn't stopping there. It is working on a fully closed-loop system using its new Harmony 1 sensor, which is expected to last 10 days. The company also expects it to be more accurate and require just one calibrating finger-stick a day, rather than the twice-daily requirement of most continuous glucose monitors.

The artificial pancreas could ramp up Medtronic's diabetes business, which booked $496 million in revenues in the most recent quarter, which ended May 31. The Diabetes Group accounted for 7% of the company's business and grew 10% last year, with insulin pump sales growing 30% outside the U.S. The company will accelerate in diabetes, with plans to roll out "more new products in the next 5 years than we have in the last 15 years," said Diabetes Group President Hooman Hakami at an investor day earlier this year.

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