Senseonics Holdings, Inc. has received CE Mark approval for the next-generation Eversense® E3 CGM System, the longest-lasting system available, with exceptional accuracy.
The CE Mark approval confirms that the Eversense E3 meets the requirements of the European Medical Device Regulation (MDR), and enables the commercialization of Eversense E3 in European Union (EU) member countries.
Senseonics’ commercial partner, Ascensia Diabetes Care, will make the improved system, which can be used for up to 6 months, available from the third quarter of 2022.
The CE Mark approval for E3 is another demonstration of our commitment to advancing implantable CGM to improve the lives of more diabetes patients worldwide. Not only does E3 strengthen our position in the market, but it enables increased operational efficiency as Senseonics will now commercialize the same product iteration globally for the first time. We are excited for Ascensia to continue to build on the momentum of the E3 launch in the U.S. as they commercialize the improved system in European markets in the coming months.Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics
The Eversense E3 CGM System has been designed to deliver key improvements from the currently available Eversense XL CGM System, which will be retired. The next-generation system offers exceptional accuracy with the longest lasting sensor available, alongside reduced frequency of calibration and enhanced sensor longevity. Unlike the XL System, the new E3 System has also been approved for non-adjunctive use, which provides for readings from the system to inform insulin treatment decisions without confirmation of glucose levels from fingerstick testing. Both Eversense XL and E3 are approved for use for up to 6 months, providing 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.
The Eversense E3 CGM System offers patients:
- Fully implantable third generation sensor, with proprietary SBA technology to enhance sensor longevity, demonstrating a mean absolute relative difference (MARD) of 8.5% in the PROMISE Studyi.
- Industry leading 6-month sensor wear duration, making Eversense the longest lasting CGM sensor available, with essentially two sensor insertion and removal procedures per year.
- Removable smart transmitter ii, held in place with a gentle, silicone-based adhesive, providing discreet on-body vibratory alerts and data transmission to a mobile app where glucose values, trends, and alerts are displayed.
Following the CE Mark approval in Europe, the E3 System will be distributed in Germany, Italy, Spain (including Andorra), the Netherlands, Poland, Switzerland, Norway and Sweden. People in these markets who are interested in getting started with Eversense XL now can visit www.ascensia.com/eversense for more information, and will be among the first to know when Eversense E3 is commercially available.