Holy Cross Hospital in Fort Lauderdale announced that it will participate in a U.S. pivotal clinical study aimed at establishing the safety and efficacy of the investigational Axium™ Neurostimulator System for patients with chronic lower limb pain.
The Axium Neurostimulator System, developed by Spinal Modulation, Inc. of Menlo Park, is a small implanted device that delivers stimulation to a specific branch in the spinal cord called the dorsal root ganglion to interrupt pain signals before they travel to the brain. While this therapy is approved throughout Europe and Australia, the device is for investigational use only in the U.S.
“Current treatments face challenges targeting chronic neuropathic pain in the feet, legs and groin,” explains Holy Cross Medical Director of Pain Medicine William Porter McRoberts. “Utilizing the standard approach of spinal cord stimulation, the Axium system applies that therapy directly to the area that processes pain signals from the peripheral nerves. Recently published European data from a non-randomized study is encouraging and reports that 78 percent of participants experienced pain relief in the lower limbs.”
