The expanded FDA approval for Eterna SCS system includes new leads that are MR conditional, that allows people with chronic pain to undergo MRI within the approved specific conditions and have a wider selection of lead options for full-body scans
Abbott gets expanded approval for Eterna SCS system. (Credit: Milad Fakurian on Unsplash)
US-based medical device company Abbott has received the US Food and Drug Administration (FDA) approval for the expanded MRI options on its Eterna spinal cord stimulation (SCS) system.
The Eterna SCS system is previously approved in the US, as the smallest implantable, rechargeable spinal cord stimulator, to treat chronic pain.
The current FDA approval expands its indication to include new leads that are MR (magnetic resonance) conditional.
It allows people with chronic pain to undergo MRI within the approved specific conditions and have a wider selection of lead options for full-body scans.
The Eterna SCS system, together with TotalScan MRI technology, will now provide full-body MRI capabilities with normal operating mode scanning with select leads, said Abbott.
Abbott neuromodulation vice president Pedro Malha said: “In the past, label restrictions have made it difficult for physicians and their patients utilizing spinal cord stimulation systems to benefit from diagnostic technology.
“With this label expansion, clinicians can now accelerate the steps required for imaging without compromising safety.”
MRI is widely used to create detailed images of the inside of the body to inform diagnoses and treatment approaches for people with chronic pain.
According to the US medical device maker, people using SCS systems often require MRIs to check the progression of diseases, such as cancer or multiple sclerosis.
With the expanded MRI labelling, its SCS system is said to speed-up scan times, reducing the wait time by almost 50% compared to commercially available SCS systems.
The TriCentrus paddle lead comes with a wide electrical array that can be scanned in normal operating mode without radiofrequency power restrictions in 1.5T MRI scanners^.
The system provides high quality images, based on improved SAR ratings on the Penta 5-column paddle lead, and MR conditionality to the 90cm Octrode stimulation lead, said Abbott.
Furthermore, the company cited positive results from a recent clinical study, in which 93% of surgeons considered MRI as an important factor while selecting best matching SCS system for their patients.
In a separate development, Abbott announced a series of new programmes under its Diversity in Clinical Trials initiative to enhance diversity in clinical trials and improve care.
The new additions to the multi-million-dollar initiative includes the partnerships, scholarships, and focus on diversified participants in the company’s own clinical trials.