St. Jude Medical Inc. announced Tuesday that it won U.S. Food & Drug Administration clearance for its Epiducer lead delivery system for neurostimulation in treatment of chronic pain.
The clearance is the first of its kind for the United States. The device allows physicians to place multiple neurostimulation leads and different types of leads through a single entry point, reducing the need for the multiple incisions typically required.
The device also allows a physician to implant STJ’s S-series paddle leads, which previously required a more invasive surgery that typically means removal of part of the vertebral bone.
Neurostimluation, or spinal cord stimulation, sends mild electrical impulses via a lead that is placed near the spine to interrupt or mask pain signals on their way to the brain. The treatment is typically used to manage chronic pain in the trunk or limbs, and often in treatment of failed back surgeries.
St. Jude is also experimenting with using deep-brain stimulation for the treatment of another kind of pain — depression.
The St. Paul-based company’s systems compete against some of the biggest players in the med-tech arena. Medtronic Inc. won CE Mark for a fully implantable peripheral nerve stimulation device in May 2011. Boston Scientific Corp. won FDA clearance for its lead system in August 2010.