The U.S. Food and Drug Administration has approved a new system that stimulates the spinal cord to relieve chronic pain.
The FDA approved the device, which is called BURSTDR spinal cord stimulation, according to St. Jude Medical Inc., which is based in St. Paul, Minn., and makes the system.
The physician-designed therapy uses intermittent "burst" pulses, which "mimic the body's natural nerve impulse patterns," the company explains in a release.
Spinal cord stimulation (SCS) is a type of neurostimulation therapy proven to be effective for many people who suffer from chronic pain.
This therapy uses a device, either implanted or external, which generates electrical pulses that interrupt pain signals that travel from the spinal cord to the brain.
St. Jude’s device is intended for people who have:
• Chronic pain in their back, arms or legs that has lasted at least six months.
• Neuropathic pain (pain marked by burning, tingling or numbness).
• Little or no relief from surgery, pain medications, nerve blocks or physical therapy.
The BurstDR device uses a small generator, similar to a pacemaker, which is implanted in the body.
The generator sends electrical pulses through wires (leads), which deliver them to nerves along the spinal cord.
The pulses modify the brain signals as they travel to different parts of the brain. These pulses change the way in which you perceive pain.
The FDA based its approval on a trial that included 100 patients and showed superior pain relief after six months compared with those who received traditional spinal cord stimulation therapy, the company says.
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