FDA Expands Approval for Abbott’s Neurostimulation for Rare Pain Disorder

Rare Daily Staff

The U.S. Food and Drug Administration has expanded MRI labeling for Abbott’s Proclaim DRG neurostimulation system, the only FDA approved dorsal root ganglion stimulation therapy.

The system is used to provide targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs by stimulating the dorsal root ganglion (DRG), which are clusters of nerve cells found along the spine.

Complex regional pain syndrome (CRPS) is a rare and painful condition that is characterized by a constant or intermittent burning, stinging or tearing sensation. CRPS has been found to be more excruciating than childbirth or amputation of a limb.

For people who suffer from the syndrome and struggle to control the pain, Proclaim DRG stimulation can be an effective option, as four out of five people who receive the therapy experience significant pain relief and improved quality of life, Abbott said.

MRI is one of the most widely used technologies to create detailed images of the inside of the body to inform diagnoses and treatment approaches for people with chronic pain. MRIs can be used to help assess the progression of CRPS. In these situations, an option like the Proclaim DRG therapy, which allows patients to receive MRI scans anywhere in the body within approved parameters, can be invaluable to the patient and radiologist.

“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,” said Timothy Deer, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, West Virginia. “With these expanded MRI capabilities, we no longer need to sacrifice superior pain relief and quality of life outcomes in exchange for MRI needs.”

Photo: Timothy Deer, President and CEO of the Spine and Nerve Centers of the Virginias