CE mark for full body MR conditional labelling for Proclaim Elite SCS system


The Proclaim Elite spinal cord stimulation (SCS) system (St Jude Medical) has received CE mark approval for full-body magnetic resonance (MR) conditional labelling. With this approval, patients who receive the Proclaim Elite SCS system can now undergo full-body magnetic resonance imaging (MRI) diagnostic scans within approved parameters.

The full-body MR conditional labelling is the second upgrade available to patients outside the United States implanted with the Proclaim Elite system, following a 2015 approval for MR Conditional labelling for head and extremity MRI scans.

With the latest approval, patients living with chronic pain who have been implanted with the Proclaim Elite SCS system may now undergo full-body MRI diagnostic scans within approved parameters while retaining access to the treatments they need, such as BurstDR stimulation.

“Providing patients with a multitude of therapy options in one device has positively impacted the way we treat chronic pain patients today,” says Dirk Rasche, functional neurosurgeon, University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. “Patients now do not only have access to both traditional SCS and BurstDR stimulation, they can also safely undergo MRI scans, a significant improvement for future neuromodulation therapy and diagnostic options.”

The Proclaim Elite SCS system offers patients a combination of the convenience of a device that does not require recharging while offering access to BurstDR stimulation technology. BurstDR stimulation is a physician-designed form of SCS clinically proven to provide patients superior pain relief (as compared to tonic stimulation) by reducing their physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring. Unlike other stimulation designs, BurstDR stimulation uses intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns.

“Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy,” says Allen W Burton, medical director of Neuromodulation and vice president of Medical Affairs at St Jude Medical. “Our new labelling 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.”

Nearly 95 million Europeans suffer from chronic pain, and the condition costs European healthcare systems a combined total of 300 billion Euro annually due to associated medical costs, lost work days and social security and welfare payments. SCS therapy can offer many patients meaningful pain relief and improvements in quality of life, yet for some patients the need for future MRI scans can act as a barrier to SCS therapy.

Full body MR-conditional labelling for the Proclaim Elite system was also recently approved by the Food and Drug Administration (FDA) in the USA.