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DUBLIN, Sept. 17, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, services and solutions, today announced the Envision™ Pro Continuous Glucose Monitoring (CGM) system — a fully disposable, zero calibration professional CGM system — has obtained CE (Conformité Européenne) Mark approval. Medtronic will begin commercial release in Europe and the Middle East this fall, subject to local regulatory requirements1. This new technology will empower healthcare professionals and their patients with either type 1 and type 2 diabetes to see accurate glucose levels and trends over time to develop more optimal diabetes therapy plans.
"Medtronic has a 20-year history in professional CGM as the first company to have an approved physician-use CGM system," said Sheri Dodd, vice president and general manager for the Non-Intensive Diabetes Therapies business at Medtronic. "The launch of the Envision Pro CGM system represents multiple important innovations as the first disposable and zero calibration CGM from Medtronic."
The glucose data collected by the Envision recorder generates up to five diagnostic reports that are reviewed by healthcare professionals with their patients. The main report, Pattern Snapshot, uses advanced pattern recognition algorithms to help advance the conversation between the healthcare provider and patient by identifying daily patterns of high and low sugar levels and their association with food, medication, exercise and sleep. With these insights, providers can facilitate therapy adjustments and provide lifestyle change recommendations to their patients in order to minimize excursions and the associated risk of complications. The Envision Pro CGM system provides accurate data that is blinded to the patient to obtain an unbiased view of their real-world glucose levels. It also has comprehensive event tracking features and easy-to-read reports, making it easier for physicians to have needed therapy discussions with their patients.
The Envision Pro system was designed with ease of use as a top priority. For instance, patients no longer need to calibrate the CGM through fingersticks. Also, there is no need to return the sensor or recorder to their physician, as both pieces are now fully disposable. The recorder communicates wirelessly with the patient’s smartphone allowing automatic data uploading so that the healthcare provider obtains the data seamlessly and can run reports remotely without additional in-office visits.
“Fingersticks and A1C only show part of how a person’s sugar levels are fluctuating throughout the day," said Professor Dr. Christophe De Block, M.D., Ph.D., head of the Department of Endocrinolgy-Diabetology-Metabolism at Antwerp University Hospital. "The Envision Pro CGM system will allow me and my patients to see the percent of time that they are in the optimal target glucose range, and when they are high or low, so that we can better uncover how food, exercise and medication affect their sugar levels. This provides me the opportunity to have more informed discussions and to customize the diabetes management plans for my patients, and augments the personal engagement of patients thereby motivating them to adhere to therapeutic advice.”
About Continuous Glucose Monitoring
Continuous Glucose Monitoring (CGM) measures glucose levels every 5 minutes using a tiny sensor inserted beneath the skin, typically in the abdomen or upper arm. There are two forms of CGM – real-time CGM and professional blinded CGM. Real-time CGM is a patient-focused tool that allows a patient with diabetes to understand how insulin and their lifestyle affect glucose levels throughout the day. It is meant to be worn for months and years. Professional blinded CGM records glucose levels just as frequently but is designed for the healthcare professional to get an unbiased snapshot of glucose trends over a week, since the glucose levels are masked and the patient can not react to real-time values during the evaluation period. It is generally used just a few times a year. The reports can empower healthcare providers with additional insights to help them develop personalized treatment plans for their patients in less time, for better diabetes management.
About the Diabetes Group at Medtronic
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.
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 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 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.
1Envision™ Pro system is not approved for use in the U.S