St. Jude Medical secures CE mark approval for Proclaim Elite Spinal Cord Stimulation System

11 December 2016 (Last Updated December 11th, 2016 18:30)

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.

St. Jude Medical secures CE mark approval for Proclaim Elite Spinal Cord Stimulation System

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.

This approval indicates that patients who receive the Proclaim Elite SCS System can now undergo full-body magnetic resonance imaging (MRI) diagnostic scans within approved parameters.

The complete-body MR conditional labeling is the second upgrade available to patients outside the US implanted with the Proclaim Elite System, after an approval for MR Conditional labeling for head and extremity MRI scans in 2015.

Patients living with chronic pain who have been implanted with the Proclaim Elite SCS System will be able to undergo full-body MRI diagnostic scans within approved parameters while retaining access to the treatments they require, such as the St. Jude Medical BurstDR stimulation.

Germany-based University Hospital of Schleswig-Holstein’s Campus Lübeck functional neurosurgeon  Dirk Rasche said: “Providing patients with a multitude of therapy options in one device has positively impacted the way we treat chronic pain patients today.

 “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 provides patients with the convenience of a device that does not need recharging whilst also offering access to St. Jude Medical BurstDR stimulation technology.

BurstDR stimulation is a physician-designed form of SCS clinically proven to offer patients with superior pain relief than tonic stimulation by reducing their physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring.

St. Jude Medical claimed that unlike other stimulation designs, its BurstDR stimulation works differently, utilising intermittent burst pulses designed to mimic the body’s natural nerve impulse patterns.

St. Jude Medical medical director of neuromodulation and vice president of medical affairs Dr. Allen W. Burton said: “Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy.

"BurstDR stimulation works differently, utilising intermittent burst pulses designed to mimic the body’s natural nerve impulse patterns."

“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.”

Almost 95 million Europeans suffer from chronic pain, and the condition costs European health care systems a combined total of 300bn annually due to associated medical costs, lost work days and social security and welfare payments.

Recently, the US FDA approved full body MR-conditional labeling for the Proclaim Elite System.


Image: Proclaim Elite Spinal Cord Stimulation System. Photo: Courtesy of Business Wire.