Medtronic receives FDA approval for non-rechargeable neurostimulator

By Elaine Rigoli

Tampa, Fla., March 24 - Medtronic, Inc. said the Food and Drug Administration has approved RestorePrime, a neurostimulation system for the treatment of chronic pain.

RestorePrime is a non-rechargeable device indicated to manage bilateral and complex pain in the trunk and/or multiple limbs that is associated with failed back surgery syndrome, post-laminectomy pain, unsuccessful disc surgery or degenerative disc disease, among others, according to a company news release.

It is designed specifically for patients with low to moderate energy requirements who need a broader range of neurostimulation coverage but prefer a non-rechargeable system.

About the size of a stopwatch, the device is typically implanted under the skin of the abdomen and connected to two leads - thin wires with electrodes at the tips. Up to 16 electrodes deliver electrical pulses to the spine.

Based on individual patient need, doctors can customize the positioning of the electrodes to deliver stimulation directly to the target area of the spine, and in doing so, block pain signals from reaching the brain, the release said.

Additionally, to cover varying levels of pain, they can choose for their patients up to 32 program options, the broadest range of any non-rechargeable device on the market, the release said.

Medtronic said it is planning an initial launch of RestorePrime in March and April, followed by full market availability in May.

Medtronic, a medical technology developer, has headquarters in Minneapolis.

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