St. Jude Medical Announces FDA Approval of a New Treatment Therapy for Patients Suffering From Chronic Intractable Pain
Dorsal root ganglion (DRG) stimulation aims to provide pain relief for patients with chronic intractable pain conditions due to complex regional pain syndrome 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 U.S., with an estimated one in every 10 adults over the age of 30 suffering from the condition.
By stimulating the DRG, a spinal structure densely populated with sensory nerves that transmit information to the brain via the spinal cord, the St. Jude Medical Axium system delivers a form of spinal stimulation that gives physicians the ability to treat the specific areas of the body where pain occurs. As a result, DRG stimulation is a first-of-its-kind therapeutic approach that provides pain relief to patients with neuropathic conditions underserved by traditional SCS who have tried multiple treatment options without receiving adequate pain relief.
"The approval of St. Jude Medical's DRG neurostimulation system represents an exciting new option for me to deploy in the fight against the focal and intractable chronic pain syndromes facing my patients every day," said Dr.
Approval of DRG stimulation with the St. Jude Medical Axium system was based in part on the results of 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). Patients in the study were randomized to receive either DRG stimulation delivered by the Axium Neurostimulator System or traditional tonic SCS therapy delivered by a competitor's system. At both three-month and 12-month intervals, results from the ACCURATE study showed DRG stimulation provided patients with superior pain relief over traditional tonic SCS.
"St. Jude Medical is focused on providing physicians with more options to treat patients suffering from a wide range of chronic pain conditions, no matter where in the body the patient may experience pain," said
The Axium system originally received CE Mark approval in November 2011 for the management of chronic intractable pain. The Axium system is also approved for use in Australia.
About the St. Jude Medical Neuromodulation Portfolio
Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact mood, personal relationships, work productivity, and activities of daily living.
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St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Laurel Hood, 651-756-2853