Abbott (NYSE:ABT) announced today that the FDA approved expanded MRI labeling for its Eterna spinal cord stimulation (SCS) system.
The expanded labeling includes new leads that are MR conditional. It means people with chronic pain can undergo MRI scans within approved, outlined conditions with a wider selection of lead options for full-body scans. Eterna SCS with TotalScan MRI now provides fully-body MRI capabilities. It also features normal operating mode scanning with select leads.
FDA approved Eterna in December 2022.
Abbott cited recent findings from its own study demonstrating that 93% of surgeons consider MRI accessibility an important to essential factor when determining the best SCS system for their patients. This study also revealed that surgeons place a high value on the ability to implant leads in the epidural space. Those surgeons want to accomplish this while still remaining capable of conducting an MRI scan anywhere on the body.
About the expanded labeling for Abbott
Under the expanded labeling, Abbott’s Eterna SCS system offers faster scan times. It offers half the wait time compared to commercially available SCS systems with lead placements anywhere along the spine, Abbott said.
The system’s TriCentrus paddle lead now features the widest electrical array available for scanning in normal operating mode. This occurs without radiofrequency power restrictions in 1.5T MRI scanners. Additionally, the new labeling enables full-body MRI capabilities with normal operating mode scanning on the TriCentrus paddle lead. It also offers improved SAR ratings on the Penta 5-column paddle lead and MR conditionality on the 90cm Octrode stimulation lead. This enables higher quality images, Abbott says.
“In the past, label restrictions have made it difficult for physicians and their patients utilizing spinal cord stimulation systems to benefit from diagnostic technology,” said Pedro Malha, VP, neuromodulation, Abbott. “With this label expansion, clinicians can now accelerate the steps required for imaging without compromising safety.”