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

Thank you Brad!

-----Original Message-----
From: email @ redacted [mailto:email @ redacted] 
Sent: Monday, July 07, 2003 4:33 PM
To: email @ redacted
Subject: [IP] FDA Approves New Minimed Paradigm/BD Logic Combo

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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
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
BD (Becton, Dickinson and Company) (BDX) , has been launched nationwide. 

This integrated system combines and simplifies two important steps in
management, blood sugar (glucose) monitoring and insulin dosing, with the
of helping patients keep their blood sugar levels within a normal range,
 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
after considering a number of variables, such as the amount of insulin 
previously delivered and still active in the body. The system simplifies
 critical information process, so patients no longer feel as though they
need to be mathematicians in order to keep their blood sugar levels in
 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
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
without frequent blood glucose monitoring and the use of an insulin pump. 

"This new system represents a significant advancement in managing diabetes.
have known for some time that an insulin pump can more closely mimic a
pancreas. Now we have harnessed the full potential of the pump with our 
patented Bolus Wizard calculator to simplify and enhance dosing decisions
anyone who uses insulin to manage their diabetes," said Jeffery A.
vice president and general manager of Medtronic MiniMed. "This dosing
 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
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
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
 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
recommends an insulin dosage based upon a blood glucose reading,
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
wish to download, store and review historical information from their
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
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
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

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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