Eversense E3 is a long-term implantable CGM system that offers diabetes patients superior accuracy for six months
Senseonics Holdings has received the Food and Drug Administration (FDA) approval for its new-generation Eversense E3 CGM System for people with diabetes.
The US medical technology company has designed the Eversense E3 CGM System to provide diabetes patients with a fully implantable third-generation sensor.
Senseonics leverages its unique sacrificial boronic acid (SBA) technology in the CGM system to extend the longevity of its sensor to six months.
With extended sensor wear duration, Eversense becomes the most enduring CGM system, with only two sensor insertion and removal procedures per year, said the company.
Senseonics president and CEO Tim Goodnow said: “Further extending the duration of the longest-lasting CGM system to 6 months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community.
“The review was delayed by one year due to Covid-19 priorities and now together with our partner Ascensia, we can execute our launch plan to deliver the Eversense E3 CGM System to U.S. patients beginning in the second quarter.
“We look forward to initiating Eversense E3 sales and believe that, with Ascensia’s newly dedicated CGM commercial organization, the launch of the new six-month product will establish the foundation for growth in our installed base later in 2022 and beyond.”
In addition to the SBA technology, the device comes with a removable smart transmitter, held in place with a mild silicone-based adhesive.
The smart transmitter provides subtle on-body vibratory alerts and data transmission to a mobile app where glucose readings, trends, and alerts are displayed.
The US FDA approval was based on results from the PROMISE Study.
PROMISE Study showed that the company’s SBA technology enhanced the longevity of the device’s sensor, with a mean absolute relative difference (MARD) of 8.5%.
PROMISE Study principal investigator Satish Garg said: “We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate.
“The next generation Eversense E3 System delivers on both. Patients will appreciate the excellent accuracy of the system and the ability of the sensor to last six months.
“This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor.”
Senseonics intends to commercialise the device in the US, through its global commercial partner Ascensia Diabetes Care, starting from the second quarter of 2022.