St. Jude Medical has secured CE mark approval for full-body magnetic resonance (MR) conditional labeling of the Proclaim Elite spinal cord stimulation (SCS) system.
The approval allows the patients who use the system to undergo full-body MRI diagnostic scans within approved parameters.
Last year, the company also received approval for MR conditional labeling of head and extremity MRI scans with the Proclaim Elite system patients.
The Proclaim Elite SCS system is said to provide access to the firm’s BurstDR stimulation technology.
BurstDR stimulation is a physician-designed form of SCS that provides pain relief to patients by reducing their physical pain.
It will address their emotional response to pain as measured by visual analogue scale (VAS) scoring.
Proclaim Elite system’s Bluetooth wireless technology enables clinicians to program and adjust their patient’s SCS therapy with an
Recently, the company also received approval from the US Food and Drug Administration (FDA) for full body MR-conditional labeling of the Proclaim Elite system.
St. Jude Medical medical affairs vice president and neuromodulation medical director Dr Allen Burton said: “Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy.
“Our new labeling for the Proclaim Elite SCS System ensures that patients can receive the treatment they need, while having peace of mind knowing their SCS system can be safely scanned with the diagnostic imaging they require.”
Image: Proclaim Elite spinal cord stimulation system. Photo: courtesy of Business Wire.