St. Jude wins MRI nod for Proclaim Elite spinal cord stim

St. Jude Medical (NYSE:STJ) said today it won FDA approval for magnetic resonance imaging conditional labeling for its Proclaim Elite spinal cord stimulation system

Patients using the company’s Proclaim Elite SCS are now cleared or full-body MRI diagnostics scans, the Little Canada, Minn.-based company said.

“This MR Conditional labeling applies to both new patients and those already implanted with the upgradeable Proclaim Elite SCS System. 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,” Dr. Thomas Yearwood of Pascagoula, Miss.-based Comprehensive Pain & Rehabilitation said in prepared remarks.

The update is the 2nd for the company on its Proclaim devices, as last month it won FDA clearance for BurstDR tech, which is designed to mimic the body’s natural nerve-firing patterns to optimize SCS treatment for chronic pain.

The BurstDR technology is available with new implantations of St. Jude’s Proclaim Elite and Prodigy MRI SCS devices; it will also be available “soon” as a non-surgical upgrade to already-implanted Protégé and Proclaim SCS systems,  St. Jude said.

“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,” Dr. Steven Falowski Of Bethlehem, Penn.-based St. Luke’s University Health Network said in a prepared release.

“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. 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,” medical affairs VP Dr. Allen Burton said in prepared remarks.

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