Medtronic Begins US Trial to Evaluate the Use of Subcutaneous Peripheral Nerve Stimulation for Chronic Back Pain

Medtronic, Inc.

today announced the first patient enrollments in the SubQStim II pivotal clinical trial to pursue U.S. Food and Drug Administration (FDA) approval of peripheral nerve stimulation (PNS), also known as subcutaneous nerve stimulation (SQS), for the reduction of chronic, intractable post-surgical back pain.   PNS involves an implant of electrical leads just under the skin of the lower back. These leads are connected to a stimulator which delivers mild electrical impulses to the nerves, interrupting pain signals traveling through the nervous system to the brain. Medtronic received CE (Conformité Européenne) Mark for the first 16-electrode, fully implantable system for the percutaneous delivery of PNS in the management of chronic back pain in May 2011. PNS using a fully implantable system is not currently approved by the U.S. Food and Drug Administration for use in the United States. The SubQStim II pivotal study is a randomized, controlled, blinded, parallel arm, multicenter trial to assess the safety and efficacy of PNS for chronic, intractable post-surgical back pain. The study will recruit up to 323 people at 30 U.S. centers who will receive PNS using a Medtronic neurostimulation system. Subjects will be randomized to a treatment or control group for the first three months and will continue to participate in open label follow-up for up to five years.