FDAnews Device Daily Bulletin

MEDTRONIC RECEIVES FDA APPROVAL FOR NEUROSTIMULATOR

March 28, 2006
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Medtronic announced FDA approval of a neurostimulation system for the treatment of chronic pain, which affects an estimated 75 million Americans.

The RestorePRIME neurostimulator is a non-rechargeable device indicated to manage bilateral and complex pain in the trunk and/or multiple limbs associated with failed back surgery syndrome, post-laminectomy pain, unsuccessful disc surgery or degenerative disc disease. It is designed specifically for patients with low to moderate energy requirements who need a broader range of neurostimulation.

Indicated for patients with intractable chronic pain of the trunk or limbs, neurostimulation works by blocking pain signals traveling up the spinal cord -- the pain pathway -- to the brain. The Restore is the first 16-electrode, neurostimulator, without the need to recharge.