FDA OKs Expanded MRI Labeling for Eterna SCS for Pain

The US Food and Drug Administration (FDA) has approved expanded MRI labeling for Abbott Laboratories' Eterna spinal cord stimulation (SCS) system, which will allow for higher-quality scan images for patients with chronic pain, the company has announced.

The Eterna system, originally approved by the FDA in December, delivers low-intensity electrical impulses to nerves along the spine to disrupt pain. According to Abbott, Eterna SCS is the smallest implantable, rechargeable system currently available for the treatment of chronic pain.

The expanded labeling announced today includes new leads that are MR conditional, allowing people with chronic pain to undergo MRI scans safely, when the conditions for safe scanning are met.

"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 Salkowski, MD, Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, Pennsylvania, said in a press release. "Abbott's Eterna SCS system helps address these barriers and concerns with new [patients], as well as previously implanted patients, delivering improved patient care and access."

Under the expanded labeling, the Eterna system includes leads that can be placed anywhere along the spine. It offers faster scan times than other commercially available systems, the company states, and enables higher-quality images.

Patients with SCS systems often require MRIs to assess the progression of illnesses such as cancer or multiple sclerosis. However, restrictions for MRI labeling can sometimes affect treatment options.

"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, MBA, vice president for neuromodulation at Abbott, said in a statement. "With this label expansion, clinicians can now accelerate the steps required for imaging without compromising safety."

Kelli Whitlock Burton is a reporter for Medscape Medical News covering neurology and psychiatry.

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Cite this: FDA OKs Expanded MRI Labeling for Eterna Spinal Cord System for Chronic Pain - Medscape - May 15, 2023.

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