CONTOUR®NEXT LINK 2.4 From Ascensia Diabetes Care, the First PMA-approved BGMS, Featured in U.S. Launch of MiniMed® 670G Hybrid Closed Loop System by Medtronic
PARSIPPANY, New Jersey, June 7, 2017 /PRNewswire/ --
Ascensia Diabetes Care today announced the commercial launch by Medtronic of the MiniMed® 670G system in the United States. The MiniMed® 670G system is the first Hybrid Closed Loop (HCL) insulin delivery system to be approved anywhere in the world and exclusively features the CONTOUR®NEXT LINK 2.4 blood glucose monitoring system (BGMS) from Ascensia Diabetes Care. The launch of this product is part of the ongoing alliance agreement between Ascensia and Medtronic, and follows approval by the U.S. Food and Drug Administration (FDA) in September 2016. The MiniMed® 670G system, which will be supplied with a CONTOUR®NEXT LINK 2.4 BGMS, will initially be shipped to those who are part of the Medtronic Priority Access Program.
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The CONTOUR®NEXT LINK 2.4 is the only BGMS FDA-approved for use as part of the MiniMed® 670G system. Both the highly accurate CONTOUR®NEXT LINK 2.4 BGMS and the CONTOUR®NEXT Test Strips have been approved through the Premarket Approval (PMA) process ─ the most stringent medical device marketing application pathway required by the FDA.
The MiniMed® 670G system features the Guardian® Sensor 3, the first and only sensor approved by the FDA to control a hybrid closed loop system, and is driven by Medtronic's most advanced algorithm, SmartGuard® HCL Technology. Alongside the CONTOUR®NEXT LINK 2.4 BGMS, these components form the world's first commercialized hybrid closed loop system, delivering a variable rate of insulin 24 hours a day based on the personalized needs of the individual with diabetes. This allows people with diabetes to minimize glucose variability and maximize the amount of time in the target range. The system is designed to learn what an individual's insulin needs are and to take action to minimize both high and low glucose levels.
The CONTOUR®NEXT LINK 2.4 BGMS was designed to wirelessly transmit highly accurate blood glucose results for CGM calibration and insulin dosing as part of the MiniMed® 670G system. The CONTOUR®NEXT LINK 2.4 BGMS automatically sends blood glucose results into the Bolus Wizard® calculator, allowing patients to discreetly give a bolus of insulin remotely from the meter, providing added convenience for patients.[1]
Robert Schumm, VP and Managing Director of Ascensia Diabetes Care US Inc., said: "We believe the MiniMed® 670G system offers significant advantages to current insulin pump products available in the U.S., and marks an important milestone towards the goal of developing a fully automated, closed loop system. The speed of the approval of the MiniMed® 670G system by the FDA is a testament to its importance and the difference it can make for people with diabetes. We are proud that our meters are an integral part of this system and are excited about the scientific advances it demonstrates."
He added: "Pairing the CONTOUR®NEXT LINK 2.4 meter with the MiniMed® 670G system allows for seamless integration of highly accurate blood glucose readings for CGM calibration, insulin dosing, and remote bolusing. Through the wireless connection it eliminates the risk of inaccuracies due to manual entry errors and allows people with diabetes to manage their condition more effectively and discreetly."
According to the FDA, the accuracy of a BGMS is an essential part of any system that is approved as an Artificial Pancreas Device System as it has a major impact on the quality of the calibration and the performance of the system.[2] In a laboratory study, the CONTOUR®NEXT LINK 2.4 Meter has been demonstrated as highly accurate with 99% of results within ± 10% of lab reference values (YSI reference) helping patients to optimize their insulin pump therapy.[3],[4]
Ascensia Diabetes Care has a global alliance agreement with Medtronic. Under the current agreement, Ascensia exclusively co-develops and supplies the CONTOUR®NEXT LINK, CONTOUR®NEXT LINK 2.4, and CONTOUR®PLUS LINK BGMSs that wirelessly communicate with compatible Medtronic integrated insulin pumps and CGMs.
Robert Schumm added, "We are thrilled that Ascensia continues to collaborate with Medtronic on providing innovative technology that offers increasingly more sophisticated solutions for people with diabetes and I look forward to the continued success of our alliance."
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 33 countries.
For further information, please visit the Ascensia Diabetes Care website at:
Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care. MiniMed and SmartGuard are trademarks and/or registered trademarks of Medtronic, MiniMed, Inc.
1. Remote bolusing available from the CONTOUR®NEXT LINK 2.4 Meter when MiniMed 670G pump is in Manual Mode.
2. Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems; issued Nov 9, 2012.
3. Bailey J WJGC. Accuracy and User Performance Evaluation of the CONTOUR®NEXT LINK 2.4 blood glucose monitoring system. Clinica Chimica Acta. 2015(448):139 -145.
4. 10% applies to blood glucose values ≥ 100 mg/dl per Section 6.3 of the ISO 15197:2013 accuracy standard. The CONTOUR®NEXT LINK 2.4 BGM system has been demonstrated to deliver at least 95% of results within ± 10% of the laboratory reference values at blood glucose levels ≥ 100 mg/dL and within ± 10 mg/dL at blood glucose values < 100 mg/dL. See the product user guide for additional information on system and user performance.
For more information, please contact:
Joseph Delahunty
VP, Global Head of Communications
Ascensia Diabetes Care
Email: [email protected]
Phone: +41-61-560-8760
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SOURCE Ascensia Diabetes Care
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