Ascensia Diabetes Care announced that it successfully completed its initial European launch for the Senseonics (NYSE:SENS) Eversense E3.
Eversense E3 represents Senseonics’ next-generation continuous glucose monitor (CGM) system. Eversense E3 can be used for up to six months (180 days). This doubles the wear time of its previous-generation CGM.
Ascensia said in a news release that its launch extends to Germany, Switzerland, Poland, Italy, Spain, Norway, Sweden, the Netherlands, and Andorra. The company began its phased rollout for Eversense E3 in August.
The system received CE mark approval in June. Europe already had a 180-day Senseonics CGM system available (Eversense XL). However, the next-generation Eversense E3 has a number of improvements over the XL. Those include reduced calibrations and enhanced survivability. Additionally, it offers non-adjunctive use, meaning fingersticks aren’t necessary for dosing decisions.
Eversense E3 received FDA approval in February. Ascensia Diabetes Care, Senseonics’ global commercial partner, launched the system in the U.S. on April 4. The first U.S. patient received the E3 implantation that same week.
“We are proud to have successfully brought the Eversense E3 to Europe, where we believe it can make a big difference in the lives of people with diabetes,” said Torstein Myher, region head of Europe at Ascensia. “The Eversense E3 CGM system makes managing diabetes easier, offering unparalleled convenience and flexibility alongside exceptional accuracy. With a six-month sensor lifespan, the system frees patients from frequent sensor insertions, and its other features have been specifically designed to address improvements desired by the diabetes community.
“We are looking forward to bringing these benefits to more people than ever.”
About the Senseonics Eversense E3
Senseonics designed the Eversense E3 with proprietary sacrificial boronic acid (SBA) technology. That enhances sensor longevity to make it what the company says is the longest-lasting CGM system. The fully implantable sensor requires just two insertion and removal procedures per year.
The system also includes a removable smart transmitter. A mild silicone-based adhesive holds the transmitter in place. This offers discreet, on-body vibratory alerts and data transmission to a mobile app. On the app, users can view glucose values, trends and alerts.
Data presented in 2021 demonstrated strong accuracy with the fully implantable, 180-day sensor. Eversense E3 matched performance levels compared to the 90-day version, but with calibration reduced to essentially once per day. In studies, the sensor has produced a mean absolute relative difference (MARD) of 8.5%, representing high accuracy.