Medical Info: Medtronic MiniMed Real Time GuardianRT CGMS

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Medtronic Announces FDA Approval Of Real-Time Continuous Glucose Monitoring System

MINNEAPOLIS – August 10, 2005 – Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration approval of the Guardian® 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 .

About Medtronic Diabetes

Medtronic Diabetes ( ) 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. ( ), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, extending life for millions of people around the world.

[Note: This was formerly referred to as the "CGMS". -Ron]
I don't know how many of you are aware of this, but Joan is a Type 1, Insulin Dependent diabetic who uses the Medtronic Minimed Insulin Pump to help manage her diabetes. Before the pump, she was taking 5 injections of insulin every day; now she inserts a small "cannula" or tiny tube under the skin once every three days. In addition to the reduced number of injections, her blood sugar immediately came into much better control. This has been a major increase in her (and my) quality of life.

However, she is testing her blood sugar with a finger stick 10-12 times every day. With this new monitor, she may be able to reduce that substantially. More importantly, she may be alerted when her blood sugar drops (or raises) unexpectedly quickly, further enhancing her blood sugar control while avoiding the life-threatening lows.

I have been following developments in this Real Time glucose monitoring field extensively for more than 7 years. In December of 1999, I went to an FDA hearing about another product called the GlucoWatch Biographer, which was reccommended for approval by the committee (to my utter shock, since the accuracy was SO BAD!) and eventually approved. The company manufacturing the GlucoWatch, Cygnus, has ceased operations and is in the process of liquidation.

I haven't seen the clinical data supplies for the approval by Medtronic to the FDA for the GuardianRT CGMS, however I hope it is far superior to the data supplied by Cygnus.

Today is our anniversary. This may be the best present ever.

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