FDA Approves Medtronic's Rechargeable Neurostimulation System

Medtronic announced that its Restore Rechargeable Neurostimulation System -- a device about the size of a stopwatch that is implanted under the skin -- is now available, following approval granted by the FDA.

The Restore battery can last for up to nine years, exceeding that of any other rechargeable spinal cord stimulator on the market. When battery levels are low, an alarm sounds and an icon appears on the system's programmer screen, alerting patients of the need to recharge. Recharging can occur without interrupting delivery of the stimulation.

The system's high-power battery offers Restore patients the convenience and flexibility of the longest time between recharge periods. Patients will typically need to recharge the Restore battery approximately once per month, whereas other devices on the market may require recharges as frequently as once per week.

The Restore System is indicated to manage chronic, difficult-to-treat pain in the trunk and/or multiple limbs that is associated with failed back syndrome, post-laminectomy pain, unsuccessful disc surgery or degenerative disc disease, among others