Medtronic, Inc. (NYSE: MDT) announces the launch of Enlite™ Sensor, the newest and most advanced glucose sensor for continuous glucose monitoring (CGM), in more than 35 countries outside of the United States. CGM has been shown in multiple landmark clinical studies to help diabetes patients achieve better glucose control without increasing hypoglycemia (low blood sugar), a dangerous and potentially life-threatening complication of diabetes. The Enlite Sensor combines greater comfort with improved glucose sensor performance in both overall accuracy and hypo detection.
When the Enlite Sensor is used with the predictive alerts feature on Medtronic systems, diabetes patients have access to hypo detection rates up to 98%. This helps give early warning to people with diabetes so they can take action to prevent dangerous hypoglycemia, which is one of the major concerns of people living with diabetes.
"The Enlite Sensor will improve patients' ability to predict and detect hypoglycemia, which can be one of the most frightening aspects of living with Type 1 diabetes," Emanuele Bosi, professor of Endocrinology, Head of the Department of Internal Medicine, San Raffaele Scientific Institute and San Raffaele Vita Salute University. "CGM is an important element in managing diabetes. The STAR 3 trial demonstrated that diabetes patients achieved better glucose control when sensors were integrated with insulin pump therapy compared to multiple daily injections. Moreover, other recent studies continue to suggest that the more often patients use CGM, the greater average glucose control they can achieve without increasing hypoglycemia."
Significant design improvements make Enlite Sensor more comfortable and easier to use than the previous sensor. In a clinical study of Enlite Sensor, 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 a significantly smaller sensor compared to Medtronic's previous product --69% smaller in sensor size by volume, 38% shorter in length. Adding to patient convenience, the Enlite Sensor can be worn on the abdomen and buttocks and used for up to six days.
"The adoption of CGM is growing rapidly, as both diabetes patients and their diabetes care professionals experience the benefits of seeing fluctuations in glucose patterns so that action can be taken to achieve better diabetes control. By making the new Enlite Sensor smaller, as well as easier to insert and wear, we expect that more people with diabetes will be able to utilize this technology to manage their condition and ultimately improve their lives," said Katie Szyman, president of the Diabetes business and senior vice president at Medtronic.
The Enlite Sensor received CE (Conformité Européenne) 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 United States. 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.
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