Successful ACCURATE study for Axium Neurostimulator System for chronic lower limb pain-St Jude Medical

St. Jude Medical, Inc.announced data from the ACCURATE Study shows that stimulation of the dorsal root ganglion (DRG) with the St. Jude Medical Axium Neurostimulator System is associated with superior pain relief over traditional spinal cord stimulation (SCS) for the treatment of chronic pain of the lower limbs.The ACCURATE study, which is designed to support U.S. approval of DRG stimulation, represents the medical device industry's largest study to date to evaluate patients suffering from chronic lower limb pain associated with complex regional pain syndrome (CRPS) or peripheral causalgia (nerve damage); two of the many chronic pain conditions currently underserved by traditional SCS therapy. Neuropathic pain represents one of the most prevalent yet under-treated chronic pain conditions currently facing U.S. patients. A total of 152 patients were enrolled in the trial at 22 centers across the United States.Patients in the study were randomized to receive either DRG stimulation delivered by the Axium Neurostimulator System or traditional SCS therapy delivered by a competitor's system (Medtronic- Restore ULTRA and RestoreSensor System ). After three months, investigators from the ACCURATE study found the trial had met its primary endpoints for both non-inferiority and superiority over traditional SCS.

Specifically, data from the ACCURATE study shows DRG stimulation delivered: Superior pain relief: Significantly more patients receiving DRG stimulation achieved significant pain relief and greater treatment success when compared to patients receiving traditional SCS (81.2 percent vs 55.7 percent). Consistent therapy: Patients receiving DRG stimulation reported no differences in paresthesia intensity due to changes in body position (known as postural effects) when compared to traditional SCS. A statistically significant result was found between the two groups studied. Postural effects can be a common challenge associated with traditional SCS therapy.Precise Anatomical Coverage: Patients in the Axium group were significantly less likely to report feeling stimulation outs.

Comment:The Axium Neurostimulator System has CE Mark in the European Union and TGA approval in Australia for the management of chronic, intractable pain.

Comment:Both the St Jude and Medtronic devices reported similar experiences with the intensity of paresthesia. This contrasts with the Senza chronic pain implant from competitor Nevro that was recently approved by the FDA and is designed specifically to eliminate the unpleasant side effect of paresthesia.