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[IP] FDA Approves New Minimed Paradigm/BD Logic Combo

First Wireless Insulin Pump System Designed to Simplify and Improve Diabetes 
Management Receives FDA Clearance
7/7/2003 3:20:00 PM

NORTHRIDGE, Calif., Jul 7, 2003 (BUSINESS WIRE) -- Medtronic MiniMed, the 
diabetes management business of Medtronic, Inc. (MDT) , today announced United 
States Food and Drug Administration (FDA) clearance of the world's 
 first "intelligent" insulin pump and glucose monitor system, which helps remove
the guesswork in insulin dosing, making it easier for patients to manage their 
 diabetes. The wireless system, comprised of a Medtronic MiniMed Paradigm(R) 512
Insulin Pump and a Paradigm Link(TM) Blood Glucose Monitor, co-developed with 
BD (Becton, Dickinson and Company) (BDX) , has been launched nationwide. 

This integrated system combines and simplifies two important steps in diabetes 
management, blood sugar (glucose) monitoring and insulin dosing, with the goal 
of helping patients keep their blood sugar levels within a normal range, which 
 can lead to improved health and extended life for many patients. Using wireless
technology, the Paradigm Link monitor automatically transmits a blood sugar 
reading to the Paradigm 512 insulin pump. The pump's Bolus Wizard(TM) 
calculator performs "diabetes math," recommending the proper insulin dosage 
based upon information preset by the user. 

"This new integrated pump and monitor system is a major breakthrough in 
diabetes management," explains Bruce Bode, M.D., FACE, medical director, 
 Diabetes Resource Center of Atlanta, Atlanta Diabetes Associates. "The new pump
system is so smart it recommends the proper insulin dosage to the patient, 
after considering a number of variables, such as the amount of insulin 
previously delivered and still active in the body. The system simplifies this 
 critical information process, so patients no longer feel as though they need to
be mathematicians in order to keep their blood sugar levels in control." 
 More than 1 million Americans with Type 1 diabetes and another 3 million Type 2
diabetes patients are estimated to use insulin to control blood sugar levels, 
improve their health and attain a better quality of life. High and low blood 
sugar fluctuations can cause loss of consciousness or even death, as well as 
long-term complications, such as blindness, kidney failure, amputation, 
impotence and heart disease. For many patients, managing diabetes is difficult 
without frequent blood glucose monitoring and the use of an insulin pump. 

"This new system represents a significant advancement in managing diabetes. We 
have known for some time that an insulin pump can more closely mimic a healthy 
pancreas. Now we have harnessed the full potential of the pump with our 
patented Bolus Wizard calculator to simplify and enhance dosing decisions for 
anyone who uses insulin to manage their diabetes," said Jeffery A. McCaulley, 
vice president and general manager of Medtronic MiniMed. "This dosing support 
 and integration of the blood glucose meter have the potential to attract a much
broader complement of patients and physicians to pump therapy." 
"The power of glucose monitoring and the benefits of insulin pump therapy are 
now combined in a patient-friendly system that can simplify and improve 
diabetes management," said Kevin Seifert, president, BD Consumer 
Healthcare. "BD's alliance with Medtronic MiniMed allows us to combine our 
expertise, intellectual property and best-in-class technologies to bring a 
series of innovative products to market, further improving the lives of people 
with diabetes." 

The System 

The Paradigm 512 Insulin Pump, which is the next generation Paradigm pump, 
 features enhanced quality components and automatically receives a blood glucose
value from the Paradigm Link monitor via wireless communication. The pump's 
 Bolus Wizard calculator recommends insulin dosage based upon preset information
entered by the user (target blood glucose, insulin sensitivity and insulin-to-
carbohydrate ratios). The pump's calculator tracks the time and amount of 
insulin delivered by the patient and makes a dosing recommendation after 
subtracting the amount of insulin still remaining in the body. The calculator 
recommends an insulin dosage based upon a blood glucose reading, carbohydrate 
entry, or both. Prior to this integrated system, many diabetes patients 
mentally calculated the amount of insulin needed, a complex process that can 
result in dosing inaccuracies and lead to less than optimal blood sugar 

The Paradigm Link Blood Glucose Monitor provides accurate glucose results in 
five seconds, uses the thinnest lancet on the market and requires one of the 
smallest test strip blood volumes (0.3 microliters). In addition to 
automatically transmitting a glucose value to the Paradigm 512 pump, the 
Paradigm Link monitor also serves as an information "conduit" for patients who 
wish to download, store and review historical information from their Paradigm 
insulin pump to a personal computer. 

Paradigm Pathway Program 

As Medtronic MiniMed continues to develop new features for its 500 series 
Paradigm pumps, users can purchase upgrades during their warranty period, in 
order to stay current with the latest technology advancements. The first 
Paradigm Pathway Program offering enables Paradigm pump users to purchase an 
upgrade and receive the Paradigm 512 and Paradigm Link monitor system. This 
pathway program is available to owners of Paradigm 511 pumps. 

BD (www.bd.com) is a medical technology company that serves healthcare 
 institutions, life science researchers, clinical laboratories, industry and the
general public. BD manufactures and sells a broad range of medical supplies, 
devices, laboratory equipment and diagnostic products. The Paradigm Link 
monitor is powered by BD Logic(TM) technology. 

 Medtronic MiniMed (www.minimed.com) 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, related 
disposables, and a continuous glucose monitoring system. Medtronic, Inc. 
(www.medtronic.com), headquartered in Minneapolis, is the world's leading 
medical technology company, providing lifelong solutions for people with 
 chronic disease. Additional information about the Paradigm 512 insulin pump and
the Paradigm Link monitor is available online at www.minimed.com/paradigmlink. 

EDITOR'S NOTE: Detailed information about diabetes, insulin pump therapy and 
the Paradigm 512 pump and Paradigm Link system is available by accessing 
Medtronic's online newsroom at www.medtronic.com/newsroom. 
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