Medtronic has enrolled the first patients in a blinded, controlled, multicenter, parallel arm SubQStim II study of its peripheral nerve stimulation (PNS).
Delivered to patients using the company's neurostimulation system, PNS is designed for the reduction of chronic, intractable post-surgical back pain.
PNS involves an implant of electrical leads connected to a stimulator that delivers mild electrical impulses to the nerves to interrupt pain signals traveling through the nervous system to the brain.
The pivotal trial, which is designed to assess the safety and efficacy, will enroll 323 patients and randomize them into a treatment or control group for the first three months.
Patients will continue to participate in open label follow-up for up to five years.
The company said it will use the positive trial results to pursue FDA approval for the device.