FDA approves Medtronic’s Enlite continuous glucose sensor

Medtronic (NYSE:MDT) said today that the FDA approved its Enlite sensor for the iPro2 Professional continuous glucose monitor.

Medtronic said the Enlite device, a disposable sensor designed to be worn for 6 days, is 69% smaller than its previous sensor. The iPro2 Professional system is designed to track glucose levels every 5 minutes, 24 hours a day, for as long as 6 days to help doctors gauge the effectiveness of nutrition, medication and exercise programs.

“We fundamentally believe that to improve outcomes for people with diabetes, physicians need advanced insights to optimize therapy and people with diabetes need to understand the context behind glucose fluctuations to drive behavior change,” non-intensive diabetes therapies general manager Laura Stoltenberg said in prepared remarks. “Our focus is to continuously enhance our professional CGM solutions and improve patient and physician experience by making the systems easier-to-use through advancements such as the Enlite sensor and our Pattern Snapshot report.”

“Both physicians and people with diabetes need easy-to-use systems which can provide actionable information. The new Enlite sensor is easy to insert and comfortable to wear. Having 6 days of patient data permits robust pattern analysis for more accurate decision support,” added non-intensive diabetes therapies medical director Dr. Robert Vigersky. “With the insights and reports provided through professional CGM, patients can be shown the factors that are driving glucose fluctuations, so together with their doctor they can develop a plan to improve glucose control.”

The iPro2 system won FDA clearance back in November 2011. Five years later Medtronic launched a new “Pattern Snapshot” report for the system, designed to give healthcare providers a 1-page overview of a patient’s glucose data trends.

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