FDA approves Axium Neurostimulator System for chronic lower limb pain- St Jude Medical

St. Jude Medical has announced FDA approval of the Axium Neurostimulator System for dorsal root ganglion (DRG) stimulation. The approval of DRG stimulation in the U.S. will ensure access to a superior therapeutic approach for treating moderate to severe chronic intractable pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS I and II). The chronic pain disorder known as CRPS often affects the extremities.

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.

Comment:The Axium system originally received CE Mark approval in November 2011 for the management of chronic intractable pain. The Axium system is also approved for use in Australia.