FDAnews
www.fdanews.com/articles/171061-st-jude-medical-acquires-spinal-modulation

St. Jude Medical Acquires Spinal Modulation

May 5, 2015

St. Jude Medical completed its acquisition of Spinal Modulation, the developer of the Axium Neurostimulator. The deal makes St. Jude the only devicemaker in the world to offer radiofrequency ablation, spinal cord stimulation and dorsal root ganglion stimulation therapy solutions for the treatment of chronic pain.

The Axium system is a form of spinal cord stimulation that targets a neural structure within the spine called the dorsal root ganglion, which contains the neurons that transmit pain signals to the brain. The system uses an implantable device to deliver mild electrical pulses to the DRG, which mask or interrupt pain signals as they travel to the brain.

The system has a CE Mark and TGA approval in Australia for the management of chronic intractable pain.

Enrollment in the device’s U.S. IDE trial has been completed, and Spinal Modulation submitted its PMA application to the FDA for approval in the U.S. — Kellen Owings