FDA approves expanded labeling for dorsal root ganglion stimulation therapy

Key Takeaways:

• The Proclaim DRG neurostimulation system aids in diagnosis and treatment of complex regional pain syndrome.
• The FDA approval allows patients to receive a full-body MRI.

The FDA has approved expanded MRI labeling for Abbott’s dorsal root ganglion stimulation therapy, which allows those with complex regional pain syndrome to receive full-body MRI scans while implanted with the device.

According to a company press release, the Proclaim DRG neurostimulation system is the only FDA-approved DRG technology that offers targeted relief for individuals with complex regional pain syndrome (CRPS) types I and II in the lower limbs by stimulating the dorsal root ganglia, clusters of nerve cells found along the spine.

CRPS is a rare and painful condition affecting approximately 200,000 people in the United States and is characterized by a constant or intermittent burning, stinging or tearing sensation, often described as “more excruciating than childbirth or amputation of a limb,” Abbott said in the release.

Proclaim DRG therapy allows patients to receive MRI scans anywhere in the body within approved parameters, leading to better assessment and tracking of CRPS symptoms, per the release.

“As we continue to work holistically across chronic pain care, we’re excited to see this new MRI expanded indication for our proprietary and unique dorsal root ganglion stimulation therapy become another valuable tool in the hands of treating physicians helping people get back to living a life on their terms,” Pedro Malha, vice president of neuromodulation at Abbott, said in the release.