Medtronic Receives FDA Approval for New Tripolar, 16-Electrode Neurostimulation Lead to Treat Chronic Pain
Specify™ 5-6-5 Surgical Lead Features DuraLoc™ Electrode Technology and Anatomical Design to Improve Therapy’s Effect on Low Back Pain
Medtronic, Inc. (NYSE: MDT), today announced that the U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) to its new Specify™ 5-6-5 surgical lead for neurostimulation therapy, a safe and effective treatment for chronic pain that uses the company’s extensive line of implantable neurostimulation systems, including the RestoreADVANCED® and PrimeADVANCED® neurostimulators.
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 that conforms to the anatomy of the epidural space. The electrodes – six in the middle column and five in each of the outside columns – are securely embedded in the paddle with patent-pending DuraLoc™ electrode technology. They are arranged in a diamond pattern that is intended to maximize therapeutic effectiveness while minimizing energy consumption. Each electrode can be activated and programmed independently, which enables customization and adjustment of neurostimulation therapy based on individual patient needs.
The new lead is the first of its kind using a tripolar design to receive a PMA from the FDA. A lead is an insulated wire that carries electrical pulses to a targeted site in the body through one or more electrodes. Neurostimulation therapy uses electrical pulses to block pain signals on their way up the spinal cord to the brain where pain is perceived. The electrical pulses are generated by an implantable medical device called a neurostimulator.
“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. Compared to a flat paddle, this anatomically conforming design also promotes more consistent contact of the three columns of electrodes with the dura, the strong fibrous membrane that surrounds and protects the spinal cord.”
The new lead capitalizes on the latest advances in Medtronic’s programming software for neurostimulation therapy when used with the RestoreADVANCED® and PrimeADVANCED® neurostimulators. The software’s TargetSTIM™ feature streamlines the process of finding each patient’s optimal stimulation target and parameters. It enables smooth transitions between electrode configurations and quickly steers stimulation to the optimal target.
“The Specify 5-6-5 surgical lead broadens and leverages our extensive portfolio of neuromodulation technology,” said Dr. Richard E. Kuntz, president of the Neuromodulation business and senior vice president of Medtronic, Inc. “It represents the latest example of our commitment to developing innovative products with clinically relevant attributes for the treatment of chronic pain and other nervous system disorders.”
Chronic pain affects an estimated 75 million people in the United States alone. Medtronic estimates that several million Americans are candidates for treatment with neurostimulation therapy. To date, approximately 200,000 people worldwide have been treated for chronic pain with Medtronic neurostimulation technology.
Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses, pharmaceuticals, and biologics to specific sites in the nervous system. The company’s Neuromodulation business offers innovative therapies for chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis.
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