Mayfield Neurosurgeons First in Region to Implant Paresthesia-Free Spinal Cord Stimulator
As the options for patients facing chronic pain continue to evolve, Mayfield Brain & Spine is the first in the region to offer groundbreaking spinal cord stimulation (SCS) therapy.
Mayfield neurosurgeons Steven Bailey, MD, and George Mandybur, MD, have implanted versions of the Senza® SCS system, a spinal cord stimulator that provides pain relief without the potentially bothersome sensations typically induced by other spinal cord stimulators. The Senza® is the first spinal cord simulator system to deliver HF10 therapy, which enables the delivery of stimulation without the tingling, burning, or prickling sensations known as paresthesia.
The Senza SCS system, marketed by Nevro Corp., is approved by the Food and Drug Administration (FDA) for the treatment of chronic pain, defined as pain that has persisted for three months or more.
HF10 therapy was found to offer superior response rates and pain relief compared to traditional stimulation therapy in patients with back and leg pain. HF10 therapy is the only SCS therapy approved by FDA with a superiority labeling. Because it is paresthesia-free, HF10 therapy is the only SCS therapy approved by the FDA to be used without patient restrictions on motor vehicle operation.
Spinal cord stimulator trials that preceded implantation of the Senza were performed by Marc Orlando, MD, a physical medicine and rehabilitation specialist.
Millions of Americans suffer from common chronic pain conditions, which can significantly interfere with quality of life, and chronic pain is the most common reason for physician visits and the primary cause of adult disability. The majority of these pain conditions are felt in the back or legs. There are a variety of treatment options for chronic pain that range from medications to surgical interventions.
Spinal cord stimulation represents an important option in the treatment of chronic pain. It involves the delivery of electrical signals to the spinal cord in order to alter pain signals to the brain. The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered generator implanted under the skin. SCS is a reversible therapy that has helped hundreds of thousands of people experience relief from chronic pain.
The basis for the FDA approval and the superiority labeling was the SENZA-RCT pivotal trial3, a clinical study that was the first to directly compare two competing SCS therapies. In the SENZA-RCT, HF10 therapy demonstrated meaningfully superior results to traditional SCS therapy for back and leg pain. In the SENZA-RCT, patients receiving HF10 therapy had a 1.5x greater likelihood of responding to the therapy over traditional SCS therapy. In addition, HF10 therapy patients achieved approximately a 50 percent greater improvement in pain score than those with traditional SCS therapy.
Mayfield Brain & Spine is the full-service patient care provider of the Mayfield Clinic, one of the nation's leading physician organizations for neurosurgical treatment, education, and research. With more than 20 specialists in neurosurgery, interventional neuroradiology, physical medicine and rehabilitation, and pain management, Mayfield Brain & Spine treats 20,000 patients from 35 states and 13 countries in a typical year. Mayfield physicians specialize in the treatment of back and neck pain, sciatica, Parkinson's disease, essential tremor, NPH, epilepsy, brain and spinal tumors, stroke, moyamoya, brain aneurysms, Chiari malformation, scoliosis, kyphosis, facial pain, facial twitch, trauma, concussion, spinal cord injury, and carpal tunnel. As leading innovators in their field, Mayfield physicians have pioneered surgical procedures and instrumentation that have revolutionized the medical art of neurosurgery for spinal diseases and disorders, brain tumors, and neurovascular diseases and disorders.