St. Jude Medical's Axium Neurostimulator System came to the company with the acquisition of Spinal Modulation, Inc. in May 2015. Axium is designed to offer pain relief using dorsal root ganglion (DRG) stimulation.
One-year data from the ACCURATE U.S. IDE trial of the technology showed, among other benefits, that 74.2% of patients who received DRG stimulation had "meaningful pain relief and greater treatment success" versus 53% of patients who had spinal cord stimulation, a statistically significant result.
Axium received CE Mark in December 2011 and a PMA application was submitted to FDA in the first quarter of 2015. According to a Seeking Alpha transcript, on St. Jude Medical's third quarter earnings call in October 2015, then-CEO Daniel Starks named the anticipated U.S. launch of DRG stimulation as one of the factors expected to boost the company's neuromodulation business in 2016.
These products do not have U.S. FDA regulatory clearance or approval as of January 22, 2016.
[Axium and St. Jude Medical are trademarks of St. Jude Medical, Inc. or its related companies. Reprinted with permission of St. Jude Medical, ©2016. All rights reserved.]
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