Ascensia Diabetes Care, a global diabetes care company, maker of CONTOUR® blood glucose monitoring (BGM) system portfolio and distributor of Eversense® Continuous Glucose Monitoring (CGM) Systems, announces that its partner Senseonics Holdings, Inc. has received CE Mark approval for the Eversense® E3 Continuous Glucose Monitoring (CGM) System, clearing the way for its use in European Union (EU) member countries. Ascensia plans to make the next-generation system, which can be used for up to 6 months, available to patients in certain European markets from the third quarter of 2022.
The fully implantable, long-term Eversense E3 CGM System has been designed to deliver key improvements on the currently available Eversense® XL CGM System, whilst building on the unique benefits that European users already experience. The next-generation system offers exceptional accuracy and long-term sensor wear, alongside reduced frequency of calibration and significantly enhanced sensor survivability. Unlike the XL System, the new E3 System has also been approved for non-adjunctive use, meaning that it can inform insulin treatment decisions without confirmation of glucose levels from fingerstick testing. Both Eversense XL and Eversense E3 are approved for use up to 6 months, making them the longest lasting CGM sensors available. This gives people with diabetes freedom from the burdens associated with other available CGM systems, such as weekly or bi-weekly self-insertions.
Eversense E3 is already available in the U.S. following FDA approval and launch earlier this year. Following the CE Mark approval in Europe the Eversense E3 System will be distributed in Germany, Italy, Spain (including Andorra), the Netherlands, Poland, Switzerland, Norway and Sweden.
Robert Schumm, President at Ascensia Diabetes Care, said, “This approval is an exciting milestone for us as we look forward to bringing Eversense E3 to people with diabetes across Europe. From this next-generation system you can expect the excellent features and benefits that European users currently experience with Eversense XL, but with design improvements that address requests we repeatedly hear from patients and healthcare providers. Our role is to make sure that as many people have access to this innovative product as possible, and efforts are already under way to launch this system in certain European countries in the coming months.”