PARSIPPANY, N.J., Feb. 14, 2022 /PRNewswire/ -- Ascensia Diabetes
Care, a global diabetes care company, announces that its partner
Senseonics Holdings, Inc. (NYSE American: SENS) has received
approval from the U.S. Food and Drug Administration (FDA)
for the next-generation Eversense® E3 Continuous
Glucose Monitoring (CGM) System. Ascensia plans to make the
Eversense E3 sensor, which can be used for up to 6 months,
available to patients in the U.S. during the second quarter of
2022.
Robert Schumm, President at
Ascensia Diabetes Care, said, "As the world's first and only
long-term CGM System, Eversense is truly innovative and the
prospect of using a single sensor for 6 months is a huge step
forward for people with diabetes. Ensuring that as many people as
possible have access to Eversense E3 is key for us and we'll be
introducing a program to help users experience Eversense affordably
as we work closely with payers on coverage. We look forward to
rolling out this next-generation system through our dedicated CGM
commercial team in the U.S. in the coming months, as we strive to
improve the lives of people with diabetes everywhere."
Developed by Senseonics and brought to people with diabetes by
Ascensia, the newly approved Eversense E3 CGM System, which
includes a sacrificial boronic acid (SBA) design modification to
enhance sensor survival, 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
- 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
- Fewer calibrations, with primarily one calibration required per
day after day 21 of use
"This next generation system delivers on the patient's desire
for a CGM sensor that is both long-lasting and highly accurate,"
said Elaine Anderson, Head of
Eversense CGM Business Unit at Ascensia Diabetes Care. "Its unique
features and benefits offer people with diabetes unparalleled
flexibility, convenience and accuracy. Our partner Senseonics has
designed Eversense E3 with the user in mind and we are excited to
bring the system to people in the U.S. in the second quarter."
To be among the first to know when Eversense E3 is commercially
available, patients who are interested in getting started with
Eversense now can sign up at
www.eversensediabetes.com/get-started-today. Physicians, nurse
practitioners and physician assistants who are interested in
offering the Eversense CGM System can sign up at
www.ascensiadiabetes.com/eversense/become-a-provider/register/.
Alternatively, contact 844-SENSE4U (844-736-7348) to learn more
about the first and only long-term implantable CGM system.
* There is no glucose data generated when the transmitter is
removed.
1 Garg S. et al. Evaluation of Accuracy and Safety
of the Next-Generation Up to 180-Day Long-Term Implantable
Eversense Continuous Glucose Monitoring System: The PROMISE Study.
Diabetes Technology & Therapeutics 2021; 24(2): 1-9.DOI:
10.1089/dia.2021.0182
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SOURCE Ascensia Diabetes Care