FDA Approves Medtronic's SynergyPlus+ Neurostimulator

The FDA has cleared Medtronic's "pain pacemaker" SynergyPlus+, a device designed to give patients more control over the delivery of stimulation that blocks pain signals from reaching the brain.

SynergyPlus+ is Medtronic's newest neurostimulation system in its implantable pain portfolio. Like its other neurostimulation devices, it is used 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.

Patients with chronic pain are implanted near the spinal cord with a flexible lead. The lead, in conjunction with an implanted neurostimulator, send electrical impulses that block pain messages to the brain. A small, hand-held device is used to control the stimulation's strength and/or coverage area. The company will market the device immediately.