Medtronic has launched Enlite Sensor, a glucose sensor for continuous glucose monitoring (CGM), in more than 35 countries outside of the US.
CGM has been shown in multiple landmark clinical studies to help diabetes patients achieve better glucose control without increasing hypoglycemia (low blood sugar).
In a clinical study, 85% of patients agreed that sensor insertion was pain free and 86% agreed that the Enlite insertion device was easy to use.
The Enlite Sensor is 69% smaller in sensor size by volume, 38% shorter in length compared to Medtronic’s previous product.
It can be worn on the abdomen and buttocks and used for up to six days.
The Enlite Sensor received CE mark approval in Paris, France and is being launched subject to other local approvals in more than 35 countries.
Medtronic is working closely with the U.S. Food and Drug Administration on plans to commercialize the product in the US.
The Enlite Sensor is labeled for use with: MiniMed Paradigm REAL-Time System, MiniMed Paradigm Veo System, Guardian REAL-Time Continuous Glucose Monitoring System and the iProTM2.