BASELSwitzerland, June 16, 2022 / PRNewswire / – Ascensia Diabetes Care, a global diabetes care company, founder of CONTOUR The Blood Glucose Monitoring (BGM) portfolio and Eversense Continuous Glucose Monitoring (CGM) system distributor, announces that its partner Senseonics Holdings, Inc. has received CE Mark approval for the Eversense SystemContinuous Glucose Monitoring System (CGM) E3, paving the way for its use in European Union (EU) member states. Ascensia plans to make the new system available for use for up to six months to patients in certain European markets from Q3 2022.
The fully implantable, long-term EversenseE3 CGM System is designed to provide significant improvements over the current Eversense SystemDeliver the XL CGM system while taking advantage of the unique benefits already enjoyed by users in Europe. The innovative system ensures exceptional accuracy and long-term wear of the sensor, as well as a reduced calibration frequency and significantly better sensor life. Unlike the XL system, the new E3 system is also approved for non-simultaneous use, meaning it can make insulin treatment decisions without fingerstick glucose testing. Both the EversenseXL and EversenseE3 are approved for use for up to six months, making them the most durable CGM sensors on the market. This relieves people with diabetes from the burden of other available CGM systems, such as self-installation of the sensor every week or every two weeks.
The EversenseE3 system is now in United States available. After CE marking in Europe, the EversenseE3 system will be sold in Germany, Italy, Spain (incl Andorra), The Netherlands, Poland, Switzerland, Norway and Sweden.
Robert Schumm, President of Ascensia Diabetes Care said: “This approval is an exciting milestone for us and we look forward to making the EversenseE3 System available to people with diabetes across Europe.” The innovative system offers great features and benefits that European users are enjoying today with EversenseXL, but thanks to design improvements to meet the requirements, we still hear from patients and healthcare professionals. Our task is to provide as many people as possible access to this innovative product. We will introduce this system in many European countries in the coming months. “
Developed by Senseonics and developed by Ascensia for people with diabetes, the newly approved EversenseE3 CGM System offers patients:
Longest-running CGM available with 6 months sensor wear and essentially two sensor insertions and removals per year
Outstanding accuracy with mean absolute relative deviation (MARD) with 8.5% included in the PROMISE study1 while wearing the sensor
Less calibration while after 21.The day of use requires mainly one calibration per day
Fully implantable fluorescence sensor with detachable smart transmitter * that delivers discreet vibration alerts on the body and sends data to the mobile app
Innovative modification of the Sacrificial Boronic Acid Technology (SBA) design to extend the 6-month sensor life
Ability to make dosing decisions without fingertip testing, thanks to an unsupported label
The features and benefits of this improved system give people with diabetes unprecedented flexibility, simplicity and accuracy. ” Elaine AndersonHead of the Eversense CGM Business Unit at Ascensia Diabetes Care Choice is critical in managing diabetes and we are proud to work with our partner Senseonics to provide patients and healthcare providers across Europe and United States to offer a unique and unique CGM option ”.
People in these markets who are interested in getting started with EversenseXL can now www.ascensia.com/eversense Visit the website for more information and be among the first to know when the EversenseE3 System will be available to market.
* No glucose data is generated when the transmitter is removed.
1Garg S et al. Next-Generation Accuracy and Safety Assessment for Eversense 180-Day Long-Term Implantable Continuous Glucose Monitoring System: PROMISE study. Diabetes technology and therapy 2021; 24 (2): 1-9.DOI: 10.1089 / dia.2021.0182