Medtronic wins FDA nod to roll out auto-stop insulin device
|Medtronic's MiniMed with Threshold Suspend technology--Courtesy of Medtronic|
The Minnesota device giant plans to ramp up production and a commercial rollout over the next several weeks for for its MiniMed 530G integrated system. Diabetes patients ages 16 and older are the target patient market for the device, though Medtronic will pursue a post-approval study in children ages 2 and up.
So why does this approval matter? It's a significant advance for Medtronic in general, and diabetes care in particular.
For one thing, MiniMed 530G works with the company's Enlite sensor, which is much more sensitive to glucose levels than previous iterations. But the major factor to consider is that the MiniMed 530G is equipped with the company's Threshold Suspend technology, which automatically stops delivering insulin based on a preset minimum threshold.
An alarm sounds first. If a patient is sleeping or passed out, the auto-stop mechanism will kick in regardless for about two hours, as long as the pre-set insulin threshold is met. The product can help patients control their diabetes more precisely without multiple daily injections.
Separately, Medtronic said it is going to focus on direct patient follow-up and "make certain manufacturing accommodations," as per the product's Sept. 19, 2013 approval and accompanying warning letter.
Medtronic celebrated the results of a 247-patient study over the summer that showed a MiniMed system enhanced with the Threshold Suspend technology reduced nighttime hypoglycemia by nearly 32%, and lowered the duration and magnitude by 37.5%. A separate Medtronic trial involving a closed-loop system is now underway with up to 85 patients at 6 U.S. sites.
"We are committed to advancing closed loop algorithms, continuous glucose monitoring and insulin delivery technologies to bring new artificial pancreas systems to market," Katie Szyman, president of Medtronic's diabetes business, said in a statement.
- read the release
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