FDA approves expanded MRI labeling for Eterna spinal cord stimulation system

Key takeaways:

• Expanded labeling allows those with chronic pain to have a wider selection of leads for full-body scans.
• Eterna spinal cord stimulation system offers faster scan times compared with currently available systems.

The FDA has approved expanded MRI labeling for Abbott’s Eterna spinal cord stimulation system, allowing those with chronic pain to undergo MRI within specific conditions and have a wider selection of lead options for full-body scans.

According to an Abbott press release, people with spinal cord stimulation systems often require MRI to evaluate disease progression of conditions such as cancer or MS, and a conditional system may not be as beneficial to the patient or the radiologist. The Eterna spinal cord stimulation, which features TotalScan MRI technology, now provides full-body MRI capabilities with normal operating mode scanning with select leads.

Recent findings from a study conducted by Abbott demonstrated that 93% of surgeons consider MRI accessibility a key factor in determining the best spinal cord stimulation system for patients, the release stated. In addition, data from the study show surgeons value implanting leads anywhere in the epidural space, while still being able to conduct MRI scans anywhere on the body.

“In the past, label restrictions have made it difficult for physicians and their patients utilizing spinal cord stimulation systems to benefit from diagnostic technology,” Pedro Malha, Abbott’s vice president of neuromodulation, said in the release. “With this label expansion, clinicians can now accelerate the steps required for imaging without compromising safety.”

According to the release, the expanded labeling of the Eterna spinal cord stimulation system provides:

• faster scan times with 50% reduced wait time compared with commercially available systems with lead placements anywhere along the spine;
• the TriCentrus paddle lead, which has the widest electrical array that can be scanned in normal operating mode without radiofrequency power restrictions in other scanners;
• full-body MRI capabilities with normal operating mode scanning on the TriCentrus lead; and
• MR conditionality to the 90 cm Octrode stimulation lead, allowing for higher quality images.

“The challenge for those who have implanted devices is the ability to secure efficient and effective scans, as well as treatment options that meet the changing needs of each patient,” Steven Falowski, MD, of Argires Marotti Neurosurgical Associates of Lancaster, said in the release. “Abbott’s Eterna SCS system helps address these barriers and concerns with new, as well as previously implanted, patients, delivering improved patient care and access.”