St. Jude announced the U.S. launch and first post-approval implants of the St. Jude Medical Axium™ Neurostimulator System for dorsal root ganglion (DRG) stimulation to treat patients with chronic pain that has been hard to control with traditional spinal cord stimulation (SCS). First commercial implants of the device occurred at the Center for Pain Relief in Charleston, W.Va. by Dr. Timothy Deer, and at the Sutter Santa Rosa Surgery and Endoscopy Center in Santa Rosa, Calif., by Dr. Jason Pope.
In the coming weeks, DRG implants will occur in half the states in the United States. St. Jude Medical has already partnered with implanting chronic pain specialists who will conduct more than 100 procedures in 59 centers nationwide in the first month after launch. Over the course of the year, the company expects to have more than 300 physicians across the country trained to effectively deliver DRG therapy to patients in immediate need of targeted stimulation to alleviate chronic pain resulting from moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.
According to the Institute of Medicine, chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. Neuropathic pain represents one of the most prevalent yet under-treated forms of chronic pain in the United States, with an estimated one in every 10 adults over the age of 30 suffering from the condition.
Initial results from the ACCURATE IDE study, the largest study to date evaluating patients suffering from neuropathic chronic intractable pain associated with CRPS I and II or peripheral causalgia (PC), showed DRG stimulation provided patients with superior pain relief over traditional tonic SCS. Approval of DRG stimulation with the St. Jude Medical Axium Neurostimulator System was based in part on the results of this study in which patients were randomized to receive either DRG stimulation delivered by the Axium neurostimulator system or traditional tonic SCS therapy delivered by a competitor’s system.
For more information, please visit St. Jude website by clicking here.
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