Medtronic Announces Approval of Enlite® Sensor for iPro®2 Professional Continuous Glucose Monitoring System in the U.S.
iPro2 Professional CGM with Enlite Provides Critical Link Between Glucose Variability and Lifestyle for Improved Diabetes Control
DUBLIN - Sept. 1, 2016 - Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the FDA approval of the Enlitesensor for use with iPro2 Professional Continuous Glucose Monitoring (CGM) system, a market-leading CGM system that enables healthcare providers to obtain a more complete picture of glucose control for the diabetes patients they treat. The Enlite sensor is a disposable glucose sensor that can be worn up to six days and provides better comfort.
Like a holter monitor for cardiovascular care, the iPro2 Professional CGM system records a patient’s glucose levels 24 hours a day for up to six days. Used intermittently, the iPro2 system provides physicians with insights into how the nutrition plan, medication regimen and daily activities affect glucose levels of people with diabetes, enabling them to know more about their patients’ glucose profile in less time and helping them to make more informed decisions regarding diabetes management. Sharing advanced insights enables patients to understand the relationship between their glucose levels and lifestyle choices. In addition, the iPro2 system delivers decision support for diabetes care providers through an algorithm-based, one-page Pattern Snapshot report that enhances their ability to quickly identify and address key problem areas.
“We fundamentally believe that to improve outcomes for people with diabetes, physicians need advanced insights to optimize therapy and people with diabetes need to understand the context behind glucose fluctuations to drive behavior change,” said Laura Stoltenberg, vice president and general manager, Non-Intensive Diabetes Therapies at Medtronic. “Our focus is to continuously enhance our professional CGM solutions and improve patient and physician experience by making the systems easier-to-use through advancements such as the Enlite sensor and our Pattern Snapshot report.”
“Both physicians and people with diabetes need easy-to-use systems which can provide actionable information. The new Enlite sensor is easy to insert and comfortable to wear. Having six days of patient data permits robust pattern analysis for more accurate decision support, “said Robert Vigersky, M.D., medical director, Non-Intensive Diabetes Therapies at Medtronic. “With the insights and reports provided through professional CGM, patients can be shown the factors that are driving glucose fluctuations, so together with their doctor they can develop a plan to improve glucose control.”
About the iPro2 Professional CGM system
iPro2 Professional CGM includes the Enlite sensor, a disposable glucose sensor that delivers better comfort and is 69% smaller than the previous Medtronic sensor. The iPro2 system also includes a small data recorder, which automatically records glucose information. Patients simply wear the small, lightweight, discreet, and watertight device while going about their normal daily activities before returning it to the clinician’s office for evaluation.
Recording glucose every five minutes, the CGM system captures up to 288 measurements a day, revealing hidden high glucose (hyperglycemia) and low glucose (hypoglycemia) fluctuations that A1C and finger sticks can miss. Since the data is masked, unbiased information can be gathered to inform therapy decisions. The system is simple to start - there is no computer required for set up and minimal patient training is required. The Enlite sensor requires a shorter sensor start-up time significantly reducing the amount of clinical staff time needed to implement the evaluation.
About the Diabetes Group at Medtronic (www.medtronicdiabetes.com)
Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
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.
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