Spinal Modulation completes enrollment for pivotal neurostimulator system trial: 3 things to know

Spinal Tech

Spinal Modulation completed enrollment of a clinical trial designed to evaluate the safety and efficacy of its Axium Neurostimulator System.

Here are three things to know about the clinical trial:

 

1. Known as the ACCURATE study, the randomized, controlled clinical trial enrolled 152 patients at 22 centers throughout the United States. This is the largest neuromodulation study to be conducted in patients suffering from nerve injuries or complex regional pain syndrome thus far.

 

"The ACCURATE trial is a landmark study that could change the way we treat these chronic pain conditions. Results from prior European studies have been promising, and we are hopeful that the ACCURATE trial will continue to substantiate the effectiveness of this therapy for our patients," said Timothy Deer, MD, co-study lead and president and CEO of the Center for Pain Relief in Charleston, W.Va.

 

2. The Axium System is a targeted form of spinal cord stimulation, which uses an implantable medical device to deliver mild electrical pulses that mask pain signals as they travel to the brain. It targets the dorsal root ganglion, a neural structure within the spine.

 

3. Investigators will present the ACCURATE trial design at the 18th Annual North American Neuromodulation Society meeting in Las Vegas, Dec. 11 to 14.

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