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August 11, 2005
Real-Time Continuous Glucose Monitoring System Approved
MINNEAPOLIS--(BUSINESS WIRE)--Aug. 10, 2005--Medtronic, Inc. (NYSE:MDT) today announced the U.S. Food and Drug Administration approval of the Guardian(R) RT Continuous Glucose Monitoring System for improved diabetes management. The system displays real-time glucose values every five minutes and alerts patients when glucose levels become too high or too low. Prior to broad distribution, the company will initiate a limited market release in select U.S. cities to further evaluate training, education and reimbursement needs.
The Guardian RT System records as many as 864 glucose readings during a three-day period using a disposable glucose sensor that connects to a transmitter and communicates to a monitor using radio frequency. The sensor measures glucose in the interstitial fluid found between the body's cells, and is typically discarded and replaced by the patient after three days of use. Glucose measurements are relayed every five minutes from the transmitter to the monitor, which displays the glucose values on its screen. Alarm thresholds can be preset to alert patients to potentially dangerous glucose levels. Trend reports and charts can be viewed after data is downloaded to a computer using therapy management software and a docking station.
The system is calibrated twice a day (every 12 hours) by entering a glucose measurement from a standard blood glucose meter into the Guardian RT's monitor. Patients can make self-management decisions after confirming with a fingerstick measurement.
The Guardian RT system is indicated for use in patients 18 years and older. It can be used by type 1 and type 2 diabetes patients who desire better glucose control to improve their health and quality of life. More information about the system can be accessed at www.minimed.com/guardianrt.
About Medtronic Diabetes
Medtronic Diabetes (www.minimed.com) is the world leader in pump therapy and continuous glucose monitoring. The company's products include external insulin pumps, related disposable products, and continuous glucose monitoring systems.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 29, 2005. Actual results may differ materially from anticipated results
Posted by Diabetologica at August 11, 2005 6:11 AM