FDA approves full-body magnetic resonance (MR) conditional labeling for the Proclaim Elite Spinal Cord Stimulation (SCS) System.-St Jude Medical.

St. Jude Medical, Inc. announced FDA approval for full-body magnetic resonance (MR) Conditional labeling for the Proclaim Elite Spinal Cord Stimulation (SCS) System. With the latest labeling 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 labeling applies to both new patients and those already implanted with the upgradeable Proclaim Elite SCS System.

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.

St. Jude Medical�s proprietary BurstDR stimulation works differently from other stimulation designs, utilizing 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.

Comment:The Proclaim Elite SCS System was the first upgradeable, recharge-free system available to people in the U.S. 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.