PARSIPPANY, N.J.--(BUSINESS WIRE)--Ascensia Diabetes Care has today announced the commercial launch and approval from the U.S. Food and Drug Administration (FDA) of the CONTOUR®NEXT LINK 2.4 Blood Glucose Monitoring System (BGMS) as part of the Medtronic MiniMed® 630G system with SmartGuard™ technology. The MiniMed® 630G system is an integrated insulin pump with Continuous Glucose Monitoring (CGM) and SmartGuardTM technology. CONTOUR®NEXT LINK 2.4 is the only BGMS that is FDA approved for use as part of the MiniMed®630G system with SmartGuard™ technology.
The CONTOUR®NEXT LINK 2.4 BGMS wirelessly sends highly accurate blood glucose results for CGM calibration and insulin dosing, and is designed exclusively for use with the MiniMed® 630G system with SmartGuard™ technology.
The CONTOUR®NEXT LINK 2.4 BGMS automatically transmits blood glucose results into the MiniMed 630G pump, eliminating manual blood glucose entry errors to the pump, which often can result in an incorrect bolus calculation on the pump. The meter also allows patients to discreetly give a bolus of insulin remotely from the meter to the pump, providing added ease of use and convenience and ease of use for patients using this system.
“We are delighted that the MiniMed®630G system with the CONTOUR®NEXT LINK 2.4 Meter will now be available to people with diabetes in the United States,” stated Robert Schumm, President of Ascensia Diabetes Care US Inc. “The accuracy of our blood glucose monitoring system combined with the new innovative technology of the MiniMed® 630G system will truly help people with diabetes manage their condition.”
The MiniMed® 630G system with SmartGuard™ technology is designed to help people with diabetes more effectively manage their treatment. The device is designed to trigger an alarm to alert users when the CGM sensor detects low blood sugar, and suspends insulin delivery if the user is immediately unresponsive to the alarm.
The CONTOUR®NEXT LINK 2.4 BGMS uses the CONTOUR®NEXT Test Strips and has been shown to deliver highly accurate blood glucose results for the MiniMed® 630G system with SmartGuard™ technology. Findings from a laboratory study have demonstrated that 99.0% of results obtained with the CONTOUR®NEXT LINK 2.4 BGMS were within ±10 mg/dL or ±10% of the YSI reference results for samples with glucose concentrations <100 mg/dL and ≥100 mg/dL, respectively.1
“Meter accuracy is particularly important for insulin pump users with regard to CGM calibration and insulin bolus calculations. The launch of the CONTOUR®NEXT LINK 2.4 Meter as part of the MiniMed® 630G system means people with diabetes in the U.S. now have access to highly accurate blood glucose monitoring, with the latest advancements in fully integrated insulin pumps” added Robert Schumm.
Ascensia Diabetes Care recently renewed its alliance with Medtronic plc to develop and market innovative diabetes management solutions for patients worldwide. As part of the agreement, Ascensia will continue to co-develop and supply CONTOUR®NEXT LINK and CONTOUR®PLUS LINK BGMSs that wirelessly communicate with compatible Medtronic integrated insulin pump and CGM systems.
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About Ascensia Diabetes Care
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.
Home to the world renowned CONTOUR® portfolio of blood glucose monitoring systems, our products combine advanced technology with user-friendly functionality that help people with diabetes to manage their condition. We are committed to continued research, innovation and development of new products and solutions. As a trusted partner in the diabetes community, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision and reliability, and that we conduct our business compliantly and with integrity.
Ascensia Diabetes Care was established in 2016 through the sale of Bayer Diabetes Care to Panasonic Healthcare Holdings Co., Ltd. Ascensia Diabetes Care products are sold in more than 125 countries. Following the close of the transaction in all countries, Ascensia Diabetes Care will have almost 1,700 employees and operations in 38 countries.
For further information please visit the Ascensia Diabetes Care website at: http://www.ascensia.com
1 Bailey TJ et al. Accuracy, Precision, and User Performance Evaluation of the CONTOUR®NEXT LINK 2.4 Blood Glucose Monitoring System. Data presented at the 7th International Conference on Advanced Technologies & Treatments for Diabetes 2014
Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care. The Bayer Cross is a registered trademark of Bayer. MiniMed, SmartGuard, Carelink are trademarks and/or registered trademarks of Medtronic plc.