FDA Approves New Medtronic Continuous Glucose Monitoring Devices For Children And Teenagers
MINNEAPOLIS – March 12, 2007 – Medtronic, Inc. (NYSE:MDT) today announced that the U.S. Food and Drug Administration (FDA) has approved new REAL-Time Continuous Glucose Monitoring (CGM) devices for children and teenagers ages 7-17. Previously approved for only adult patients, Medtronic's REAL-Time CGM will soon be available in specifically designed pediatric models of the MiniMed Paradigm® REAL-Time System and Guardian® REAL-Time System.
"This indication reinforces Medtronic's commitment to developing and marketing novel therapies for the millions of Americans with diabetes," says Chris O'Connell, President of Medtronic's diabetes business. "We are particularly excited that children and their families will sleep better at night knowing that REAL-Time CGM is providing a new level of protection against dangerous glucose levels."
Medtronic REAL-Time CGM therapy is clinically proven to help patients monitor and better control their diabetes. Clinical studies have shown that Medtronic REAL-Time CGM therapy can reduce the duration of hypoglycemic events, and lower HbA1c levels by as much as two percentage points. This is significant because as much as 60 percent of hypoglycemic events go undetected by current glucose monitoring standards, and for every one percentage point drop in HbA1c, there is a 35 percent reduction in diabetes-related complications like blindness, amputation and organ failure.
"Diabetes management is especially difficult for pediatric patients, and Medtronic REAL-Time CGM therapy could benefit thousands of children and their families who struggle to maintain control of their disease," says Dr. Bruce Buckingham, director of Pediatric Endocrinology at Lucille Packard Children's Hospital, Stanford University. "By providing real-time glucose values and alarms, patients can now recognize previously undetected glucose fluctuations."
Medtronic REAL-Time CGM technology displays REAL-Time glucose values, trend graphs and directional arrows, allowing patients to discover how diet, exercise, medication and lifestyle affect their glucose levels. With this information, patients can gain valuable insights and intervene earlier to reduce the frequency and severity of high and low glucose levels. The technology alerts patients if their glucose levels fall below—or rise above—preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a meter blood glucose measurement may be required. All therapy adjustments should be based on measurements obtained using a home glucose meter and not on Medtronic REAL-Time CGM System values.
Medtronic currently markets the MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System – the world's first insulin pump with REAL-Time continuous glucose monitoring. The MiniMed Paradigm REAL-Time System has all of the benefits of CGM plus the added value of precise insulin delivery through the use of insulin pump therapy. The Guardian REAL-Time System, a stand-alone CGM device, will be available later this year.
Children with Diabetes Statistics
- More than one million patients in the US have type 1 diabetes, often referred to as juvenile diabetes.
- Of the 30,000 new patients diagnosed with type 1 diabetes every year, almost half, or 13,000 patients, are children.
- There are more than 175,000 type 1 diabetes patients under 20 years of age. More than one in every 600 children globally has type 1 diabetes, and recent studies suggest that the global incidence in children and adolescents is increasing by roughly 3 percent annually.
- According to the American Diabetes Association, almost 21 million Americans (seven percent of the population) have diabetes.
- Diabetes is the fifth-deadliest disease in the United States, affecting children and adults, and costing the United States more than $132 billion in direct and indirect costs.
- About 28 percent of diabetes patients use insulin to control their disease. That means almost six million Americans require insulin to manage their diabetes.
About the Diabetes Business at Medtronic
The diabetes business at Medtronic (www.medtronic-diabetes.com) is the world leader in diabetes management. The company's products include insulin pump therapy, continuous glucose monitoring systems, related disposable products and diabetes management software.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology, alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
See also FDA Approves New Medtronic Continuous Glucose Monitoring Devices for Children and Teenagers at the Medtronic Diabetes web site.
Last Updated: Tuesday March 27, 2007 07:52:38
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