The FDA has (finally) approved the MiniMed 530G with the Enlite sensor, Medtronic’s first-generation artificial pancreas system with Threshold Suspend automation. Medtronic’s system is the first in the United States that can automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient doesn’t respond to the Threshold Suspend alarm. The MiniMed 530G system incorporates the new Enlite sensor, Medtronic’s most accurate and comfortable continuous glucose sensor with a 31 percent improvement in overall accuracy from the previous generation
In addition to the 31 percent improvement in overall accuracy, the Enlite sensor detects up to 93 percent of hypoglycemia episodes when predictive and threshold alerts are on. The Enlite sensor is also 69 percent smaller than the previous Medtronic sensor and the new Enlite serter provides a simpler sensor insertion process with a hidden-introducer needle. The Enlite sensor can be worn for six days.
The MiniMed 530G system was approved for use by people with diabetes ages 16 and older. Medtronic will conduct a post-approval study including children ages two and older.
Medtronic says it will begin ramping up production immediately to prepare for a launch of the MiniMed 530G in the next several weeks. In the meantime, customers can find additional product and important safety information at www.medtronicdiabetes.com.