Study shows new SCS lead is safe for MRI use

Investigators recently demonstrated in a presentation the safety of and effects of heating on a new spinal cord stimulation lead designed to be compatible with MRI machines.

MRI machines can cause a rise in the temperature in the electrode of a spinal cord stimulation (SCS) device, which could possibly cause unsafe conditions for a patient, according to a press release.

“This work was used to demonstrate safety for the first FDA-approved, full-body MRI, conditionally-safe SCS system,” Heather Orser, PhD, stated in the release, which addressed results of an animal study and subsequent human morphology research presented at the American Academy of Pain Medicine Annual Meeting. “Approval of the system allows SCS patients safe access to the diagnostic benefits provided by MRI for scans of any part of the body,” she stated.

After using the animal model, scientists performed simulations of clinical lead paths in multiple human models and combined results with lead characterization analyses to predict the rise in temperature for the electrodes in the spinal cord for each possible patient situation.

Orser and colleagues found the temperatures varied significantly across 10,000 different patients, device scenarios and MRI scenarios. However, according to the release, the resulting temperature predictions demonstrated that a lead designed for reduced radiofrequency heating produced temperatures below 43º C for the full range of scenarios during 30 minutes of active scanning.

Reference:

Orser H. Poster #147. Presented at: American Academy of Pain Management Annual meeting. March 5-9, 2014; Phoenix.

Disclosure: Orser is the principal electrical engineer with the Neuromodulation business of Medtronic, which funded the study.