St. Jude wins FDA green light for Axium chronic pain device

St. Jude Medical (NYSE:STJ) said today it won FDA premarket approval for its Axium neurostimulator system using dorsal root ganglion stimulation.

The device from St. Paul, Minn.-based St. Jude is designed to treat moderate to severe chronic intractable pain of the lower limbs in adult patients with complex regional pain syndrome.

“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. 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,” Dr. Timothy Deer of Charleston, W.V.’s Center for Pain Relief said in prepared remarks.

Through stimulation of the dorsal root ganglion, a spinal structure populated with sensory nerves that transfer information to the brain via the spinal cord, clinicians are able to treat the specific areas of the body where pain occurs, St. Jude said.

The device could allow pain relief to patients with neuropathic conditions currently underserved by traditional spinal cord stimulation, the company said.

“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. The addition of DRG stimulation to our portfolio demonstrates our continued commitment to ensuring physicians have the broadest range of meaningful chronic pain therapy options,” medical affairs veep Dr. Allen Burton said in a press release.

Approval was based in part on the company’s Accurate IDE study which evaluated CRPS patients over 12 months treated with either DRG or SCS procedures and showed the DRG provided superior pain relief, the company said.

St. Jude won CE Mark approval in the European union for the Axium system in November 2011 for treating chronic intractable pain, and the system has also been approved for use in Australia.

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