FDA APPROVES EXPANDED MRI LABELLING FOR ABBOTT'S ETERNA SCS SYSTEM

Abbott announced that the U.S. Food and Drug Administration (FDA) has approved expanded MRI labelling for its Eterna™ spinal cord stimulation (SCS) system to include new leads that are MR conditional, which means 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. The Eterna SCS system with TotalScan™ MRI technology now provides full-body MRI capabilities with normal operating mode scanning with select leads.

MRI is one of the most widely used technologies to create detailed images of the inside of the body to inform diagnoses and treatment approaches for people with chronic pain. People with SCS systems often require MRIs to assess the progression of illnesses such as cancer or multiple sclerosis. In these situations, an MR-conditional system can be invaluable to the patient and radiologist. Recent findings from a study conducted by Abbott have shown that 93% of surgeons consider MRI accessibility an important to essential factor when determining the best SCS system for their patients.4 The study also revealed that surgeons place a high value on the ability to implant leads anywhere in the epidural space, which is between the vertebrae and the spinal cord, while still being able to conduct an MRI scan anywhere on the body.

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, which are thin wires that deliver low-energy pulses to the nerves along the spine to disrupt pain. Under the expanded labelling, Abbott’s Eterna SCS system offers:

For more information, visit: https://www.neuromodulation.abbott/us/en/important-safety-information.html#tabs-225fbd84da-item-f9bf8b6dac

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