Medtronic Receives FDA Approval for Guardian(R) REAL-Time Continuous Glucose Monitoring System; System Provides Patients Superior Protection than Fingersticks Alone.MINNEAPOLIS -- Medtronic, Inc. (NYSE NYSE See: New York Stock Exchange :MDT MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ) today announced that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved the Guardian(R) REAL-Time System, a doctor-prescribed continuous glucose monitoring glucose monitoring Lab medicine The periodic evaluation of any analyte abnormal in Pts with DM, to assess short and long-term control with antiglycemic agents. See Glucose, Glycated hemoglobin. (CGM (1) (Computer Graphics Metafile) An ISO/IEC standard format for 2D graphics images introduced in 1987. Primarily a vector graphics format for technical illustrations and geophysical visualizations, CGM also supports raster graphics and text. ) system for improved diabetes management. Especially well suited for diabetes patients who frequently monitor their glucose levels, the Guardian REAL-Time System is intended to help protect patients by alerting users to high and low glucose levels. The REAL-Time information and retrospective glucose trend data provided by the Guardian REAL-Time System are designed to help patients more tightly control glucose levels. Improved glucose control has been shown to significantly reduce the likelihood of certain long-term complications, including blindness, kidney failure kidney failure or renal failure Partial or complete loss of kidney function. Acute failure causes reduced urine output and blood chemical imbalance, including uremia. Most patients recover within six weeks. , amputation amputation (ăm'pyətā`shən), removal of all or part of a limb or other body part. Although amputation has been practiced for centuries, the development of sophisticated techniques for treatment and prevention of infection has greatly , impotence, and heart disease. The system will be available nationwide by the end of this year. "The Guardian REAL-Time System is the culmination of more than seven years of research into continuous glucose monitoring technology," said Robert Guezuraga, president of the Diabetes business at Medtronic. "With more than 2,400 patient years of glucose monitoring, and more than 470,000 glucose sensors shipped, Medtronic is leading the way with the newest generation in continuous glucose monitoring technology." Unique features only available with the Guardian REAL-Time System include predictive and rate-of-change alarms and expanded trend graphs. In addition to high and low glucose alerts, these new predictive alarms are designed to warn patients of significant glucose changes well before they become dangerous. Comprehensive trend graphs show the effect of diet, exercise, medication, and lifestyle on glucose values in three, six, 12, and 24 hour increments. All glucose data can be downloaded using the Medtronic CareLink(R) Therapy Management Software. The Guardian REAL-Time System glucose sensor is a tiny electrode inserted under the skin that measures glucose levels in the interstitial fluid found between the body's cells. The sensor is connected to a transmitter that sends glucose readings every five minutes to a monitor, which displays up to 288 readings a day - nearly 100 times more information than conventional monitoring.(a) This additional information provides better protection against frequent glycemic Glycemic The presence of glucose in the blood. Mentioned in: Cholesterol, High glycemic pertaining to the level of glucose in the blood. highs and lows, and empowers patients to be more proactive about their diabetes management. CGM technology identifies four-times more glucose excursions requiring therapy adjustment than just fingerstick monitoring alone. REAL-Time alarms help reduce the duration of hypoglycemic hypoglycemic /hy·po·gly·ce·mic/ (-gli-sem´ik) 1. pertaining to, characterized by, or causing hypoglycemia. 2. an agent that lowers blood glucose levels. (low blood sugar) episodes by 48 percent. The Guardian REAL-Time System is indicated for continuous or periodic monitoring of glucose levels of adults (ages 18 and older) with diabetes mellitus for the purposes of improving diabetes management. The glucose sensor is typically discarded and replaced after three days of use. All therapy adjustments should be based on measurements obtained using a blood glucose meter (fingerstick measurement). The device requires one calibration point every 12 hours. Current standards for assessing glucose control include A1C A1C abbr. airman first class tests and fingerstick measurements, yet both have limitations. An A1C test, which measures glucose control during a three-month period, is important for long-term management, but it is only an average and does not reveal day-to-day glucose fluctuations that can harm the body. In turn, fingerstick measurements only reveal a glucose value at a single moment in time. As a result, patients are unable to detect approximately 60 percent of hypoglycemic events, and have difficulty assessing glucose fluctuations while they sleep. Medtronic Diabetes currently markets the CGMS CGMS Continuous Glucose Monitoring System CGMS Copy Generation Management System CGMS Coordination Group for Meteorological Satellites CGMS Crop Growth Monitoring System CGMS Coordination on Geostationary Meteorological Satellites (R) System Gold and the recently FDA approved MiniMed Paradigm(R) 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. Medtronic Diabetes continues to lead the industry in developing new medical device technologies to improve overall diabetes management. Diabetes Statistics According to the American Diabetes Association The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of , almost 21 million Americans (seven percent of the population) have the disease. Diabetes affects children and adults, costing the United States more than $132 billion in direct and indirect costs. (a) Based on three fingersticks a day About Medtronic's Diabetes Business The Diabetes business at Medtronic (www.minimed.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 Diabetes Management Software refers to software tools than run on personal computers and personal digital assistants to help persons with type 1 diabetes manage the data associated with:
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 Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results. |
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