(Image courtesy of Boston Scientific Neuromodulation Corporation.)
The U.S. Food and Drug Administration (FDA) has approved a new device that promises to bring drug-free relief of chronic pain in the back, the trunk area, and the lower limbs. It’s called the Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulator System and is made by the Boston Scientific Neuromodulation Corporation.
Spinal nerve stimulators that use electrical pulses to block pain signals to the brain have been around for a while, but they’ve been large devices that need frequent charging. The Boston System, which is about the size of a pacemaker, is the smallest one yet. A health-care provider implants the stimulator device through a small incision in the patient’s back. The provider then programs the device to create electrical signals that stimulate the spinal cord and block pain signals from traveling to the brain. The patient uses a hand-held wireless remote control to operate the device and achieve optimal pain control.
According to the manufacturer, the Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulator System works on “pain on one or both sides of the trunk associated with failed back surgery, low back pain, and some kinds of leg pain.” Other painful conditions it can treat include herniated disc, radicular pain syndrome, epidural fibrosis, degenerative disc disease, multiple back surgeries, and complex regional pain syndrome, or CRPS, which is a long-lasting pain condition that usually affects one limb after an injury. The manufacturer says that most health insurance plans, including Medicare and most workers’ compensation programs, cover the system.
A review of 22 clinical studies of the device found an improvement in pain for CRPS patients ranging from about 30% at the low end to 100% at the high end. For back and leg pain associated with surgery, the figures ranged from 37% to 77%. According to Maulik Nanavaty, president of the Neuromodulation division of Boston Scientific, the system uses a special algorithm to “deliver multiple waveforms.” He says that the data from studies show that the system is a “significant advancement for improving the lives of patients with chronic pain.”
Want to learn more about spinal cord stimulators? Read “How Spinal Cord Stimulation Can Alleviate Chronic Pain.”