New glucose monitoring system from Edwards Lifesciences and Dexcom receives the CE Mark

Edwards Lifesciences Corporation (NYSE: EW), the leader in the sciences of heart valves and hemodynamic monitoring, and DexCom, Inc. (NASDAQ: DXCM), a medical device company focused on the design, development and commercialization of continuous glucose monitoring systems, today announced the receipt of CE Mark for an automatic glucose monitoring system. Edwards and DexCom co-developed this new system, which is indicated for automatic, real-time monitoring and trending of blood glucose concentration in critically ill adults in the hospital environment. This CE Mark allows for commercialization of the system in the European Union and the countries in Asia and Latin America that recognize the CE Mark. Market evaluations of a first generation product are expected to begin in a limited number of European sites before the end of the year.

Studies have shown that hospitalized patients can be at a higher risk of infection and other complications if their blood glucose level is elevated for prolonged periods. Currently, clinicians manage patients' glucose levels by manually obtaining intermittent samples over various periods of time. Methods for obtaining blood samples can be labor intensive and may not provide complete information about a patient's glucose status. This glucose monitoring system will perform multiple automatic readings per hour that may provide a new level of trending insight designed to enable clinicians to effectively implement glycemic control.

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