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Ascensia Diabetes Care Receives CE Mark Approval for the Eversense® E3 Continuous Glucose Monitoring System

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.

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Ascensia Diabetes Care 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.”

Developed by Senseonics and brought to people with diabetes by Ascensia, the newly approved Eversense E3 CGM System offers patients:

The longest lasting CGM available, with 6-month sensor wear duration and essentially two sensor insertion and removal procedures per year

Exceptional accuracy, with a mean absolute relative difference (MARD) of 8.5% demonstrated in the PROMISE Study1 for the duration of sensor wear

Fewer calibrations, with primarily one calibration required per day after day 21 of use

A fully implantable fluorescence-based sensor, with a removable smart transmitter* that provides discreet on-body vibratory alerts and transmits data to a mobile app

An innovative sacrificial boronic acid (SBA) design modification to enhance 6-month sensor survivability

An ability to make dosing decisions without fingerstick testing, due to non-adjunctive label

“The features and benefits of this improved system offer people with diabetes unparalleled flexibility, convenience and accuracy,” said Elaine Anderson, Head of Eversense CGM Business Unit at Ascensia Diabetes Care. “Choice is key in managing diabetes and we are proud to work alongside our partner Senseonics to bring an outstanding and unique CGM option to patients and healthcare providers across Europe and in the U.S.”

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.

* There is no glucose data generated when the transmitter is removed.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
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