The US Food and Drug Administration (FDA) has approved an 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 undergo full-body MRI scans while the device is implanted.
„The ability to perform full-body MRI scans with the Proclaim DRG neurostimulation system means that as physicians, we can ensure that people receive the care they need in a timely manner, as they do not have to search for a facility that can accommodate this,“ said Timothy Deer, MD, President and CEO of the Spine and Nerve Centers of the Virginias in Charleston, West Virginia, in a press release from Abbott. „We can consider specific MRI settings for their device.“
„With these expanded MRI capabilities, we no longer have to compromise superior pain relief and quality of life in exchange for MRI requirements,“ Deer added.
CRPS is a rare form of chronic pain that typically occurs after an injury, surgery, stroke, or heart attack. The pain is disproportionate to the severity of the original injury and is characterized by persistent or intermittent burning, stabbing, or tearing.
DRG neurostimulation can be an effective option, as four out of five patients who have had the system implanted experience significant pain relief and improved quality of life, as evidenced by the results of the ACCURATE study.
With the expanded MRI labeling, Abbott’s Proclaim DRG neurostimulation system will allow for full-body scans for new and existing patients under approved conditions; safe scanning of any body part with standard MRI scanners; and compatibility with 50cm SlimTip DRG electrodes.
Detailed prescribing and safety information for the system is available online.