The US Food and Drug Administration (FDA) has approved full-body magnetic resonance (MR) conditional labelling for the Proclaim Elite spinal cord stimulation (SCS) system (St Jude Medical). With the latest labelling approval, patients who receive the Proclaim Elite SCS system can now undergo full-body magnetic resonance imaging (MRI) diagnostic scans within approved parameters and access the benefits of BurstDR stimulation therapy.
“This MR Conditional labelling applies to both new patients and those already implanted with the upgradeable Proclaim Elite SCS System,” says Thomas L Yearwood of Comprehensive Pain & Rehabilitation in Pascagoula, USA. “I am very grateful that I can now safely expand access to the superior therapeutic outcomes offered by BurstDR stimulation to my patients who may need a full-body MRI in the future.”
According to St Jude Medical, full-body MRI compatibility is the second major upgrade to the Proclaim Elite SCS system following the recent approval of BurstDR stimulation. Current and future patients who get the Proclaim Elite SCS system will now have access to both full-body MRI scans within approved parameters and BurstDR stimulation. St Jude Medical designed the Proclaim Elite SCS system to offer patients future approved upgrades through software updates without the need to surgically replace their device.
BurstDR stimulation works differently from other stimulation designs, utilising intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns. 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.
“The addition of full-body MR Conditional labelling for the Proclaim Elite SCS system will be another critical benefit for my patients and will help me ensure those who may one day need an MRI can benefit without fear of putting themselves and their implant at risk,” says Steven M Falowski, chief of functional neurosurgery at St Luke’s University Health Network in Bethlehem, USA.
The Proclaim Elite SCS System was the first upgradeable, recharge-free system available to people in the USA suffering from chronic pain. The system’s Bluetooth wireless technology allows patients to control and adjust their SCS therapy with an Apple iPod touch mobile digital device. St Jude Medical designed many elements of the Proclaim system based on physician and patient feedback, such as removing the burden of regularly recharging the SCS system.
“Today, physicians treating patients with chronic pain need new therapy options that consistently put the patient first and ensure minimal disruption to their daily life,” says Allen W Burton, medical director of neuromodulation and vice president of medical affairs at St Jude Medical. “Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy. Our new labelling for the Proclaim Elite SCS system ensures that patients can receive BurstDR stimulation while having the peace of mind knowing their SCS system can be safely scanned with diagnostic imaging.”