Abbott has announced that the US Food and Drug Administration (FDA) has approved expanded magnetic resonance imaging (MRI) labelling for its dorsal root ganglion (DRG) stimulation therapy, the Proclaim DRG neurostimulation system, which allows patients to receive full-body MRI scans while implanted with the device.
The Proclaim DRG neurostimulation system is “the only US FDA-approved DRG technology”, providing targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs by stimulating the DRG, as per a recent press release from Abbott. 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, the release adds.
Abbott also notes that MRIs can be used to help assess the progression of CRPS and, in these situations, an option like 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 (Spine and Nerve Centers of the Virginias, Charleston, USA). “With these expanded MRI capabilities, we no longer need to sacrifice superior pain relief and quality-of-life outcomes in exchange for MRI needs.”
With this expanded MRI labelling, Abbott’s Proclaim DRG neurostimulation system will offer:
- Full-body scans for new and existing patients, providing near- and long-term flexibility for their imaging needs
- Safe scanning of any body part with standard MRI scanners, making finding an imaging centre more straightforward for patients and doctors
- Compatibility with 50cm SlimTip DRG leads
“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,” said Pedro Malha, vice president, neuromodulation, Abbott.
