One of the limitations of medical device implants are that they historically restricted patients from getting MRIs. Device manufacturers have been working on new designs and materials to work around the challenge.
This week, St. Jude Medical announced in a press release that their Proclaim Elite Spinal Cord Stimulation (SCS) System has gained FDA approval for full-body MRI. This means that people who use the system for pain control can undergo the MRI diagnostic scans
“This MRI Conditional labeling applies to both new patients and those already implanted with the upgradeable Proclaim Elite SCS System,” said Dr. Thomas L. Yearwood of Comprehensive Pain & Rehabilitation in Pascagoula, Mississippi. “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 BurstDR stimulation utilizes intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns. BurstDR stimulation is a clinically proven to provide superior pain relief (as compared to tonic stimulation) by reducing physical pain and addressing their emotional response to pain as measured by visual analogue scale (VAS) scoring.
“The addition of full-body MR Conditional labeling 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 from St. Jude Medical’s innovations without fear of putting themselves and their implant at risk,” said Dr. Steven M. Falowski, chief of functional neurosurgery at St. Luke’s University Health Network in Bethlehem, Pennsylvania.
“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, M.D., 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.”