Medtronic Announces FDA Approval Of CGMS(R) IPRO(TM) Continuous Glucose Recorder

Main Category: Diabetes
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 31 Jan 2008 - 3:00 PDT

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Medtronic, Inc. (NYSE: MDT) announced the FDA approval of a new physician-use continuous glucose monitoring (CGM) system, the CGMS® iPro™ Recorder. Physicians send patients home with the CGMS iPro Recorder to uncover patterns and potential problems that often go undetected with today's standard glucose measurements like finger stick meters and HbA1c tests.

The new CGMS iPro Recorder is smaller, lighter in weight and less time consuming to use than previous CGMS recorders. Physicians can now gain added clinical insights from the CGMS iPro Recorder in a matter of minutes, while improved ergonomics give patients added freedom when wearing the device. Physician services associated with CGMS iPro are reimbursed from Medicare in all 50 states and have broad private insurance reimbursement.

Patients wear the CGMS iPro Recorder for three days, after which physicians can review the data and use the results to uncover glucose patterns and optimize patient therapy. Based on the detailed glycemic profiles collected from the CGMS iPro Recorder, physicians can better tailor diabetes treatment programs for each patient. This may be particularly helpful for patients who experience inconsistent high and low glucose levels, who experience hypoglycemia unawareness and who generally desire better control, as well as for women with gestational diabetes and pregnant women with diabetes.

"Diabetes is a disease of individuals, and requires very specific and customized care for each patient," said Thomas Blevins, M.D., Texas Diabetes and Endocrinology, Austin, Texas. "iPro will help me work with my patients to identify how everyday activities can affect their diabetes management. A tool like this has the ability to open a window into a patient's diabetes in a way that A1c and fingerstick measurements cannot."

The CGMS iPro Recorder is attached to a tiny glucose sensor inserted just under the skin. During the course of three days, the recorder automatically measures and stores glucose values during daily activities like work, sleep, eating, and exercise. After the recording period is completed, the patient returns to the physician's office where the device is removed and downloaded. The physician can then generate and interpret detailed glucose reports to determine changes to the patient's therapy.

"CGMS iPro is the latest step in Medtronic's CGM technology revolution," said Chris O'Connell, president of the Diabetes business at Medtronic. "Medtronic has 10 years of CGM experience, and we continue to expand the application of our technologies into new and novel spaces. CGMS iPro represents a major breakthrough in making CGM a more central element of physician practice."

Diabetes Statistics

According to the American Diabetes Association, 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 healthcare expenditures.

About The Diabetes Business at Medtronic

The Diabetes business at Medtronic 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.

http://www.medtronicdiabetes.com

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology, alleviating pain, restoring health and extending life for millions of people around the world.

http://www.medtronic.com