Real-time glucose monitoring device approved in US
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BY OUR PHARMA CORRESPONDENT
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 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.
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. 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 patient’s
heart rhythm, as well as improve the heart’s
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 industry’s 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 industry’s
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,
Parkinson’s 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.
BY OUR PHARMA CORRESPONDENT |
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