A full-body MR conditional labeling has received approval from the U.S. Food and Drug Administration for the Proclaim Elite Spinal Cord Stimulation System.

Patients who use the Proclaim Elite SCS system are now able to undergo full-body MRI scans, per approval, as well as gain 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,” said Thomas L. Yearwood, MD, PhD, of Comprehensive Pain & Rehabilitation in a statement. “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.”

St. Jude Medical’s proprietary BurstDR stimulation utilizes intermittent “burst” pulses, which is in sequence with the body’s natural nerve impulse patterns. This stimulation reduces patients physical pain and addresses their emotional response to pain as measured by visual analogue scale scoring.

“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,” said Allen W. Burton, MD, 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 labeling 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.”