Global medical device firm Medtronic has received an approval from the US Food and Drug Administration (FDA) for the MiniMed 530G with Enlite, a first-generation artificial pancreas system with threshold suspend automation for diabetes patients.
The MiniMed 530G system incorporates the company’s most accurate and comfortable continuous glucose sensor Enlite that detects about 93% of hypoglycemia episodes when predictive and threshold alerts are on.
The sensor is also 69% smaller compared to Medtronic sensor and the new Enlite serter provides a simpler sensor insertion process with a hidden-introducer needle.
Enlite sensor, which can be worn for six days, delivers better comfort and reliable CGM accuracy in addition to the 31% improvement in overall accuracy.
It is reportedly the first artificial pancreas system in the US that can automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient does not respond to the threshold suspend alarm.
MiniMed 530G system can be used only in diabetic patients of ages 16 years or above and the company will conduct a post-approval study including children ages two and older.
Medtronic Diabetes business president Katie Szyman noted the company is excited to bring yet another important ‘first’ to the US.
"The MiniMed 530G with Enlite can help people gain better control of their diabetes versus multiple daily injections. We are committed to advancing closed loop algorithms, continuous glucose monitoring and insulin delivery technologies to bring new artificial pancreas systems to market," Szyman added.
The company will soon start increasing the production of the MiniMed 530G system for a product launch in the near future.