Senseonics Eversense Sensor Receives MRI Conditional Approval in Europe

Senseonics Holdings Inc., a medical technology company focused on the development and commercialization of the first and only long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, announced regulatory approval that the Eversense XL Sensor is no longer contraindicated for MRI (magnetic resonance imaging), which means that the sensor does NOT need to be removed from under the skin during MRI scanning. During scanning the external Eversense Smart Transmitter must still be removed, and once scanning is completed, the transmitter is easily repositioned on the skin.
 
“Similar to our approved U.S. indication, the European notified body has now approved that Eversense is safe for patients to leave the Eversense XL Sensor in place when they need to have an MRI,”* said Tim Goodnow, Ph.D., president and CEO of Senseonics. “Now people using Eversense CGM can be confident that they don’t need to worry about an emergency MRI or delay undergoing a scheduled MRI based on their choice of glucose sensors. This is a first for the CGM category as all other sensors are required to be removed during an MRI scan.”
 
A patient with this device can be safely scanned in an MRI system meeting the following conditions:

• Static magnetic field of 1.5T or 3.0T
• Maximum spatial field gradient of 1900 gauss/cm (19 T/m)
• Maximum MRI system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode) for 15 minutes of continuous scanning, or SAR of 2 W/kg for 30 minutes of continuous scanning.
• The on-body Eversense Smart Transmitter, however, must be removed before undergoing an MRI procedure. 

The Eversense XL CGM System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. In addition to featuring the first long-term and first implantable CGM sensor, the system is also first to feature a smart transmitter that provides wearers with discreet on-body vibratory alerts for high and low glucose and can be removed, recharged and re-attached to the skin without discarding the sensor. The sensor is inserted subcutaneously in the upper arm by a healthcare provider via a brief in-office procedure and lasts up to 180 days. 

*MRI Safety Information
Non-clinical testing has demonstrated the Eversense Sensor is MR Conditional. A patient with this device can be safely scanned in a horizontal, closed bore MR scanner meeting the following conditions:

• Static magnetic field of 1.5T or 3.0T
• Maximum spatial field gradient of 1900 gauss/cm (19 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode) for 15 minutes of continuous scanning, or SAR of 2 W/kg for 30 minutes of continuous scanning.
• The Eversense Smart Transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI procedure. Before you undergo an MRI procedure, tell the MRI staff that you have an Eversense Sensor and Smart Transmitter.

Under the scan conditions defined above, non-clinical testing results indicate the Eversense Sensor is expected to produce a maximum temperature rise of less than 5.4 degrees Celsius. In non-clinical testing, the image artifact caused by the device extends approximately 2.83 inches (72 mm) from the Eversense Sensor when imaged with a gradient echo pulse sequence and a 3T MR system. The Eversense Sensor has not been tested in MR systems that do not meet the conditions above. Exposing the Eversense Sensor to MRI conditions which are outside of the conditions outlined above can cause potential complications such as device migration, heating and tissue damage or erosion through the skin.