FDAnews Device Daily Bulletin

St. Jude Medical Reports Positive Results for Axium Neurostimulator System

Dec. 15, 2015

St. Jude Medical has announced positive results for its Axium neurostimulator system for the treatment of complex regional pain syndrome.

Using dorsal root ganglion stimulation, the system provided sustained and superior pain relief versus traditional spinal cord stimulation in patients, according to the St. Paul, Minn.-based company.

The study found that 74.2 percent of patients receiving DRG stimulation achieved meaningful pain relief and greater treatment success, compared with 53 percent of patients receiving traditional SCS.

St. Jude submitted a premarket approval submission to the FDA for approval of DRG stimulation in the first quarter of this year. The system has been available in Europe since 2011. — Michael Cipriano