FDA Lifts Restrictions on Spinal Cord Stimulation System

The US Food and Drug Administration (FDA) has approved updated labeling that expands MRI compatibility for Abbot’s Proclaim XR spinal cord stimulation (SCS) system, the company announced.

The FDA originally approved the Proclaim XR neurostimulation system for patients with chronic pain in 2019, as reported at the time by Medscape Medical News.

The new labeling lifts MRI restrictions on the location of the Octrode leads. The 60-cm lead tips can now be placed anywhere along the spine and still be considered “MR conditional.”

The new labeling also lifts restriction on the amount of radiofrequency power that can be used as part of the normal operating mode of an MRI scan. Radiofrequency energy no longer needs to be limited with Proclaim and Octrode devices as long as the MRI is in the normal operating mode.

The changes also mean that patients with a Proclaim XR SCS device only need to wait 30 minutes between scan cycles of 30 minutes.

In general, the FDA requires radiologists to pause MRIs for 30 to 60 minutes between scan cycles for patients with implants.

“Under the expanded MRI labeling, patients with a Proclaim XR SCS device can benefit from higher quality images with faster MRI scan times,” Abbott said in a press release.

“The expanded labeling and reduced scan time address two major issues we face with these implantable devices,” Steven Falowski, MD, neurosurgeon at Neurosurgical Associates of Lancaster in Pennsylvania, added in the same release.

“By improving the quality of imaging, as well as the experience for both the patient and radiologist, I can now enable more of my existing and new patients to benefit from MRI scans improving their care,” Falowski said.

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