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Medtronic, Inc. (MDT) Remote Diabetes Monitor Gets US Approval


1/4/2012 6:19:29 AM

MINNEAPOLIS--(BUSINESS WIRE)--Today, Medtronic, Inc. (NYSE:MDT) announced U.S. Food and Drug Administration (FDA) approval and U.S. market launch of the first-of-its-kind mySentry™ Remote Glucose Monitor, which allows a parent or caregiver to monitor from another room a patient’s MiniMed Paradigm® REAL-Time Revel™ System. The remote glucose monitor also marks the launch of a new category of Connected Care solutions that will provide people with diabetes and their caregivers convenient options to access their diabetes management information.

mySentry allows caregivers to see real-time insulin pump status and glucose trends, as well as hear alerts and alarms, at their bedside while an adult or child with diabetes sleeps in his or her own room. This could be especially useful for parents, who could be alerted through a predictive alarm in the middle of the night if their child’s glucose levels are falling, allowing them to take action to prevent an episode of low blood sugar (hypoglycemia). For a caregiver of someone with type 1 diabetes, nighttime hypoglycemia (low blood sugar) represents one of their greatest concerns.

“Many of the parents of our patients wake up a couple of times every night to check their child’s blood sugar level and even that may not be enough to prevent episodes of severe hypoglycemia,” said William Tamborlane, M.D., Chief of Pediatric Endocrinology and Deputy Director of the Yale Center for Clinical Investigation. “Advances in continuous glucose monitoring, including remote monitoring like mySentry, have given parents an added level of protection from dangerous nighttime hypoglycemia occurring in their sleeping child, as well as a means to improve their quality of life.”

An estimated 75 percent of all episodes of severe hypoglycemia in children occur at night1. By alerting a parent or caregiver to an alarm, mySentry may provide added nighttime protection.

“We’re excited to bring this new innovation to market that could give caregivers greater peace of mind. The mySentry Remote Glucose Monitor is the first step toward our vision to develop an entire category of Connected Care products that help people more proactively manage their diabetes by making it easier and more convenient to access the wealth of information captured by our integrated insulin pump and continuous glucose monitoring (CGM) system,” said Greg Meehan, Vice President and General Manager of the Continuous Glucose Monitoring business at Medtronic.

mySentry is used in conjunction with the MiniMed Paradigm®REAL-Time Revel™ System, an insulin pump with built-in continuous glucose monitoring. mySentry can be placed in the bedroom or in any room throughout the house so all important information is just a glance away. mySentry provides flexibility and a wide range of uses including displaying all of the alerts and alarms available on the Paradigm Revel insulin pump: predictive alerts, continuous glucose monitoring (CGM) graph, insulin pump battery life, amount of insulin remaining, and time until the next glucose sensor calibration.

Medtronic is committed to working with health insurance providers to ensure access to and reimbursement for the product. More information is available at www.medtronicdiabetes.com/mysentry.

About the Diabetes Business at Medtronic

The Diabetes business at Medtronic (www.medtronicdiabetes.com) is the world leader in advanced diabetes management solutions, including integrated diabetes management systems, insulin pump therapy, continuous glucose monitoring systems and therapy management software, as well as world-class, 24/7 expert consumer and professional service and support.

About Medtronic

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 periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

1 Ahmet A, Dagneais S, Barrowman NJ, et al. Prevalence of Nocturnal Hypoglycemia in Pediatric Type 1 Diabetes: A Pilot Study Using Continuous Glucose Monitoring. J Pediatrics,159:2,297-302.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50120013&lang=en

Contacts

Medtronic, Inc.

Public Relations:

Amanda Sheldon, 818-576-4826

or

Investor Relations:

Jeff Warren, 763-505-2696


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