The US Food and Drug Administration (FDA) has approved expanded MRI labeling for Abbott’s Proclaim dorsal root ganglion (DRG) neurostimulator system in patients with complex regional pain syndrome (CRPS) of the lower limbs.
The updated labeling allows patients to receive full-body MRI scans while implanted with the device.
“The ability to do full-body MRI scans with the Proclaim DRG neurostimulation system means that, as physicians, we can ensure that people are receiving the care they need in a timely manner because they aren’t having to search for a facility that can accommodate special MRI settings for their device,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, West Virginia, said in an Abbott news release.
“With these expanded MRI capabilities, we no longer need to sacrifice superior pain relief and quality of life outcomes in exchange for MRI needs,” Deer added.
CRPS is a rare form of chronic pain that typically develops after an injury, surgery, stroke or heart attack. The pain is out of proportion to the severity of the initial injury and is characterized by a constant or intermittent burning, stinging, or tearing sensation.
DRG neurostimulation can be an effective option, with 4 out of 5 patients implanted with the system experiencing significant pain relief and improved quality of life, results from the ACCURATE trial show.
With the expanded MRI labeling, Abbott says the Proclaim DRG neurostimulation system will allow full-body scans for new and existing patients within approved conditions; safe scanning of any body part with standard MRI scanners; and compatibility with 50cm SlimTip DRG leads.
Detailed prescription and safety information on the system is available online.
Source link : https://www.medscape.com/viewarticle/fda-oks-full-body-mri-neurostimulation-system-lower-limb-2024a10001hv?src=rss
Publish date : 2024-01-18 18:54:07
Copyright for syndicated content belongs to the linked Source.