St. Jude Medical Announces Data From ACCURATE Study - Quick Facts

(RTTNews) - St. Jude Medical Inc. (STJ) 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 or 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. 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.