FDA approves Medtronic back pain device
Medical equipment manufacturer Medtronic announced yesterday FDA pre-market approval of the company’s new Specify 5-6-5 surgical lead for neurostimulation therapy.
Designed to improve the effect of neurostimulation therapy on low back pain, the Specify 5-6-5 surgical lead features 16 electrodes arrayed in three columns on a durable, flexible, curved paddle. It is the first lead using a tripolar design to receive pre-market approval from the U.S. Food and Drug Administration.
“The Specify 5-6-5 surgical lead from Medtronic optimizes the tripolar design,” according to neurosurgeon Dr. Michael Turner of Indianapolis Neurosurgical Group in Indiana. “The curved shape of the paddle allows for an improved anatomical fit within the epidural space, which itself is curved to conform to the cylindrical shape of the spinal cord, and should therefore minimize the potential for lateral lead migration.”
Approximately 200,000 people worldwide have already been treated for chronic pain using Medtronic’s neurostimulation technology.