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[IP] closing the loop-check this out

this is what i call documentation and progress...look out all you
pessimists...proofs in the trials...  :) cheers, bassem

   Research Presented At ADA Annual Meeting Demonstrates Accuracy and
Feasibility of Artificial Pancreas Components

Investigational device mimics a pancreas, brings an artificial pancreas one
step closer to reality

SAN FRANCISCO - June 17, 2002 - An artificial pancreas has long been
considered the Holy Grail of diabetes management, yet many people with
diabetes and their physicians believe that it is decades away. However,
Medtronic MiniMed, the diabetes management business of Medtronic, Inc. (NYSE:
MDT), today announced results of research indicating that a medical device
mimicking the human pancreas is closer to becoming a reality. The study,
conducted by investigators at the Department of Endocrine Diseases,
Lapeyronie Hospital in Montpellier, France, and sponsored by Medtronic
MiniMed in Northridge, Calif., was presented during the annual meeting of the
American Diabetes Association (ADA). Long-Term Sensor System Evaluated The
study presented at the ADA annual meeting and conducted in France, "Accuracy
of Real- Time Blood Glucose Measurement by Long-Term Sensor System Allows
Automated Insulin Delivery in Diabetic Patients," was designed to assess the
sensor accuracy over a six-month period and to test automated insulin
delivery according to the sensor's signal. Five Type 1 diabetes patients were
implanted with a long-term glucose sensor and an implantable insulin pump,
which together comprise Medtronic MiniMed's Long-Term Sensor Systemb". In
system, an implantable sensor, which measures glucose levels using an
enzyme-based electrochemical technology, was inserted in the bloodstream near
the right atrium of the heart. An abdominal lead was used to connect the
implantable sensor to a Medtronic MiniMed Model 2007 implantable pump, which
can be programmed to deliver insulin to a patient using a hand-held remote
programmer. At weekly intervals during the six-month study, glucose readings
taken by the implantable sensors were compared with the results of at least
six daily capillary blood glucose (CBG) measurements, more commonly known as
"finger stick" tests. Cumulative data from the implantable sensors strongly
correlated with the CBG results, with an r-value of 0.83 to 0.93. The closer
the r-value is to 1.0, the higher the direct correlation is between the
device and the results measured in blood sugars. Over a two-day period,
investigators also tested the system in a "closed-loop" setting, in which
continuous glucose data from the sensor was used to automatically regulate
insulin delivery from the implantable pump. In this system, the amount of
insulin required to manage a patient's diabetes is calculated using a
mathematical algorithm. The researchers found that glucose levels of patients
using the implantable sensor were maintained in a near-normal range (70 to
120 mg/dL) more often (42.3 percent of the time) than patients whose insulin
requirements were determined by CBG measurements (21.6 percent of the
time)."We are extremely pleased with the accuracy of the implantable sensor
over the course of the study, and the promising results of our closed-loop
trial," said Eric Renard, M.D., Ph.D., lead investigator of the study and
Professor of Endocrinology, Diabetes and Metabolism, Montpellier Medical
School, Montpellier I University; Senior Medical Practitioner, Department of
Endocrine Diseases of Lapeyronie Hospital in Montpellier, France. "In using a
sensor-augmented system, we are essentially creating an artificial pancreas.
This type of system is intended to help people who are unable to control
their diabetes despite intensive insulin therapy." "While implantable sensors
are still being tested, Medtronic MiniMed's Continuous Glucose Monitoring
System, which uses an external sensor, is being used today by clinicians for
improved diabetes management," added Alan Marcus, M.D., F.A.C.P., associate
clinical professor, University of Southern California Keck School of
Medicine, who has extensively studied and authored many articles using the
system. "The external sensor, which is generally worn by a patient for up to
three days, can provide up to 288 glucose values retrospectively over a
24-hour period, and offers far more comprehensive information than nominal
glucose measurements obtained by patients using traditional strips and
Latest Closed-Loop Results In the fourth and most recent closed-loop
experiment, the company combined an algorithm for calculating insulin
requirements with a pre-meal bolus (extra insulin delivered by the
implantable pump) to address high blood sugar that is normally associated
with meal consumption. By delivering a pre-meal bolus, the magnitude and
duration of post-meal hyperglycemia (high blood sugar) were greatly reduced
without increasing hypoglycemia (low blood sugar). In diabetes patients,
hypoglycemia can occur when a patient attempts to lower elevated blood sugars
by delivering extra insulin. Over a 24-hour period, hypoglycemia was reduced
by more than 50 percent. Moreover, the patient spent nearly 50 percent more
time between 70 and 120 mg/dl (the study's stringent target range), resulting
in overall improved glycemic control. "We are delighted with the positive
results of this fourth closed-loop study using our Long-Term Sensor System,"
said Scott R. Ward, Senior Corporate Vice President and President, Medtronic
Neurological and Diabetes. "Medtronic MiniMed has a vast amount of experience
in conducting closed-loop studies, and we continue to refine our algorithms
to further strengthen our knowledge of glycemic control. Our product pipeline
includes advanced algorithms that work with both external and implantable
sensors and insulin pumps. We are committed to developing an artificial
pancreas, in which a system continuously records glucose and delivers insulin
automatically, without the patient intervention that is necessary today."
Medtronic MiniMed (<A HREF="http://www.minimed.com/">www.minimed.com</A>)
designs, develops, manufactures and
markets advanced infusion systems with a primary emphasis on the intensive
management of diabetes. The company's products include external pumps and
related disposables; a continuous glucose monitoring system; an implantable
insulin pump, which currently is approved for distribution in the European
Union, and is under clinical investigation in the United States; and an
implantable sensor, which is in clinical trials prior to FDA submission.
Medtronic, Inc. <A
/A>), headquartered in
Minneapolis, is the world's leading medical technology company, providing
lifelong solutions for people with chronic disease. More information about
pump therapy and continuous glucose monitoring is available online at <A
www.medtronic.com/newsroom/media_kits_Diabetes.html</A>. - 0 -
For a brief statement about the use of the CGMS system, please <A
indications.pdf">click here</A>.
EDITOR'S NOTE: Detailed information about diabetes, insulin pump therapy,
continuous glucose monitoring devices and the Paradigm pump is available by
accessing Medtronic's online newsroom at <A
Any statements made about the company's anticipated regulatory approvals are
forward-looking statements subject to risks and uncertainties such as those
described in the company's Annual Report on Form 10-K for the year ended
April 27, 2001. Actual results may differ materially from anticipated

Components of the artificial pancreas, including the implantable pump and the
implantable sensor or long-term sensor system, mentioned in this document are
intended for investigational use only and have not been reviewed for safety
and efficacy by the U.S. Food and Drug Administration


Kevin Lee, Investor Relations, 763-505-2695

Deanne McLaughlin, Medtronic MiniMed, 818-576-4325
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