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Real-time glucose monitoring device approved in US



13th August,2005:A device to monitor fluctuation in the blood glucose levels has been granted approval by the U.S. Food and Drug Administration.
The new device named Guardian RT Continuous Glucose Monitoring System is developed by Medtronic.

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, a Medtronic release said.

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 bodyís 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 RTís 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.

Medtronic Diabetes is the world leader in pump therapy and continuous glucose monitoring. The companyís products include external insulin pumps, related disposable products, and continuous glucose monitoring systems. In 1983, the company introduced continuous insulin delivery, through first insulin pump.

Apart from Medtronic Diabetes, Medtronic has Medtronic Cardiac Rhythm Management; Medtronic Cardiac Surgery develops; Medtronic Vascular; Medtronic Spinal and Navigation; Medtronic Neurological business divisions.

Medtronic Cardiac Rhythm Management (CRM) develops products that restore and regulate a patientís heart rhythm, as well as improve the heartís pumping function. The business markets implantable pacemakers, defibrillators, cardiac ablation catheters, monitoring and diagnostic devices and cardiac resynchronization devices, including the first implantable device for the treatment of heart failure. In addition, the business markets automated external defibrillators (AEDs) and the CareLink Patient Network, the industryís first Internet-based network to enable physicians to remotely monitor their patients who have cardiac devices.
Medtronic Cardiac Surgery develops products that are used in both arrested and beating heart bypass surgery. The business also markets the industryís broadest line of heart valve products for replacement and repair, plus autotransfusion equipment and disposable devices for handling and monitoring blood during major surgery, as well as cardiac ablation devices to treat a variety of heart conditions.

Medtronic Vascular offers products and therapies that treat a wide range of vascular diseases and conditions. These products include coronary, peripheral and neurovascular stents, stent graft systems for diseases and conditions throughout the aorta, and distal protection systems. The business is also moving forward with the development of a drug-eluting stent to prevent restenosis. Medtronic Vascular also markets a full line of balloon angioplasty catheters, guide catheters, guidewires, diagnostic catheters and accessories.

Medtronic Neurological offers neurostimulation and drug pump and infusion therapies for chronic pain, Parkinsonís disease and other common movement disorders. It also offers diagnostics and therapeutics for gastrointestinal and urological conditions, including incontinence, benign prostatic hyperplasia (BPH)/enlarged prostrate and gastroesophageal reflux disease.

Medtronic Spinal and Navigation develops and manufactures products that treat a variety of disorders of the cranium and spine, including traumatically induced conditions, deformities and tumors. Through the introduction of INFUSE? Bone Graft and Minimal Access Spinal Technologies, the business has distinguished itself as a global leader in less-invasive surgical techniques. It also develops a variety of image-guided surgical navigation systems.

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology.

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