People suffering from complex regional pain syndrome (CRPS) will have a new therapy available now that St Jude Medical (NYSE: STJ) received FDA approval for the Axium Neurostimulator System — a dorsal root ganglion (DRG) stimulation technology.
“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. Timothy Deer, an interventional pain physician, president and CEO of the Center for Pain Relief in a press release. “For the large and growing numbers of under-treated patients suffering from complex regional pain syndromes – like those resulting from total knee arthroscopy, foot surgery or hernia surgery – DRG stimulation can offer improved, long-lasting relief.”
The regulatory approval was based on results from St. Jude’s ACCURATE IDE study, which evaluated patients suffering from neuropathic, chronic, intractable pain associated with CRPS (types I and II), or peripheral Causalgia (PC). In the study patients were randomized between using the DRG stimulation compared to traditional spinal cord stimulation (SCS). The study showed that at the three-month and 12-month intervals DRG stimulation provided “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 Allen Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical.
Complex regional pain syndrome (CRPS), also known as, reflex sympathetic dystrophy syndrome (RSD), is described by National Pain Report partner, RSDSA, this way:
“CRPS/RSD is a chronic neuro-inflammatory disorder. It is classified as a rare disorder by the United States Food and Drug Administration. However, up to 200,000 individuals experience this condition in the United States, alone, in any given year.
CRPS occurs when the nervous system and the immune system malfunction as they respond to tissue damage from trauma. The nerves misfire, sending constant pain signals to the brain. The level of pain is measured as one of the most severe on the McGill University Pain Scale.
CRPS generally follows a musculoskeletal injury, a nerve injury, surgery or immobilization.
The persistent pain and disability associated with CRPS/RSD require coordinated, interdisciplinary, patient-centered care to achieve pain reduction/cessation and better function.”
St. Jude said the new DRG neuromodulation therapy will be available to physicians and patients “in the coming months.”