Abbott has announced that the US Food and Drug Administration (FDA) has approved expanded magnetic resonance imaging (MRI) labelling for its Eterna spinal cord stimulation (SCS) system to include new leads that are MR conditional—meaning people with chronic pain can undergo MRI scans within the approved outlined conditions and have a wider selection of lead options for full-body scans.
As such, the Eterna SCS system with TotalScan MRI technology now provides full-body MRI capabilities with normal operating mode scanning with select leads, as per a press release from Abbott.
The release details that recent findings from a study conducted by the company have shown that 93% of surgeons consider MRI accessibility an important-to-essential factor when determining the best SCS system for their patients. The study also revealed that surgeons place a high value on the ability to implant leads anywhere in the epidural space between the vertebrae and the spinal cord while still being able to conduct an MRI scan anywhere on the body.
“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,” said Steven Falowski (Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, USA). “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.”
The release goes on to state that restrictions for MRI labelling often pose challenges for doctors when it comes to selecting the right treatment approach for their patients, including the need to have access to a range of MR-conditional leads—thin wires that deliver low-energy pulses to the nerves along the spine to disrupt pain. Under this newly expanded labelling, Abbott’s Eterna SCS system offers:
- Overall faster scan times with half the wait time as compared to commercially available SCS systems with lead placements anywhere along the spine
- The TriCentrus paddle lead has the widest electrical array that can be scanned in normal operating mode without radiofrequency power restrictions in 1.5T MRI scanners
- Full-body MRI capabilities with normal operating mode scanning on the TriCentrus paddle lead, improved specific absorption rate (SAR) ratings on the Penta five-column paddle lead, and MR conditionality to the 90cm Octrode stimulation lead, enabling higher-quality images
“In the past, label restrictions have made it difficult for physicians and their patients utilising spinal cord stimulation systems to benefit from diagnostic technology,” said Pedro Malha, vice president, neuromodulation, Abbott. “With this label expansion, clinicians can now accelerate the steps required for imaging without compromising safety.”