In May 2011 Medtronic received the CE Mark for the first 16-electrode, fully implantable system for the percutaneous delivery of peripheral nerve stimulation (PNS) in the management of chronic 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 today announced the first patient enrollments in the SubQStim II pivotal clinical trial to pursue FDA approval PNS (also known as subcutaneous nerve stimulation or SQS), for the reduction of chronic, intractable post-surgical back pain.
According to the press release:
“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.
“The SubQStim II pivotal study will provide new information about subcutaneous nerve stimulation as a potentially valuable treatment option for U.S. patients with chronic, intractable back pain who have found insufficient relief with other treatment options,” said the study’s coordinating investigator, George Mandybur, M.D., Associate Professor and Director Stereotactic and Functional Neurosurgery at the University of Cincinnati and a neurosurgeon with the Mayfield Clinic.
The first enrollments were performed by principal investigators Yeshvant Navalgund, M.D., of DNA Advanced Pain Treatment Center in Greensburg, Pennsylvania, and D. Joseph Meyer, M.D., Ph.D., of Columbia Interventional Pain Center in Columbia, Missouri. “Study findings will provide an unprecedented understanding of how leads placed in the subcutaneous tissue layer work with neurostimulation devices to help patients manage their chronic back pain,” said Dr. Navalgund.”