St. Jude Medical an**unced that its Axium neurostimulator has been Approved by the FDA to help treat*moderate to severe chronic intractable Pain of the lower limbs in adults with Complex Regional Pain syndrome (CRPS I and II) by stimulating the*dorsal root ganglion (DRG).
The DRG is an interesting target*to stimulate electrically due its location and sensory nerve density. Because signals from the lower limbs pass through the ganglion and toward the brain, St. Jude believes physicians will have better options to target different Pain sources. Hopefully patients for whom traditional spinal cord stimulation was **t appropriate or effective will find DRG stimulation to be just the thing.
Some details, according to St. Jude, on what led to the approval:
Approval of DRG stimulation with the St. Jude Medical Axium system was based in part on the results of the ACCURATE IDE study, the largest study to date evaluating patients suffering from neuropathic chronic intractable Pain associated with CRPS I and II or peripheral causalgia (PC). Patients in the study were randomized to receive either DRG stimulation delivered by the Axium Neurostimulator System or traditional tonic SCS therapy delivered by a competitor’s system. At both three-month and 12-month intervals, results from the ACCURATE study showed DRG stimulation provided patients with superior Pain relief over traditional tonic SCS.
02-19-2016, 10:00 AM
St. Jude Medical’s Axium DRG Stimulator Approved by FDA for Complex Regional Pain Syn
العرض العادي
