St Jude Medical announces CE Mark for Proclaim Elite SCS System magnetic resonance (MRI) conditional labeling.
St. Jude Medical, Inc. has announced CE mark approval for full-body magnetic resonance (MR) conditional labeling conditional labeling of the Proclaim Elite Spinal Cord Stimulation (SCS) System. With the latest 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 labeling is the second upgrade available to patients outside the United States implanted with the Proclaim Elite System, following a 2015 approval for MR Conditional labeling 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 the St. Jude Medical BurstDR stimulation
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