Business Wire06.25.20
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:
*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:
“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.
*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.