By Pat Anson, Editor
A new type of spinal cord stimulator (SCS) provides significantly more relief from chronic back and leg pain than traditional SCS therapy, according to the results of a new study published in the journal Anesthesiology.
The Senza spinal cord stimulator, which recently won approval from the U.S. Food and Drug Administration, uses high frequency pulses of 10,000 Hz to mask a patient’s perception of pain. Traditional SCS therapies use frequencies of 40 to 60 Hz.
"This is the first long-term study to compare the safety and effectiveness of high frequency and traditional SCS therapy for back and leg pain," said lead author Leonardo Kapural, MD, professor of anesthesiology at Wake Forest University School of Medicine and clinical director at the Carolinas Pain Institute.
"Chronic back and leg pain have long been considered difficult to treat and current pain relief options such as opioids have limited effectiveness and commonly known side effects. Given the prevalence of chronic pain, high frequency SCS is an exciting advance for our patients."
In a study of 171 patients with implanted SCS devices, 85 percent of those with back pain and 83 percent with leg pain using the Senza HF10 stimulator had a 50% reduction in pain or greater after three months.
Only about half the patients implanted with a traditional SCS device (44% with back pain and 56% with leg pain) experienced that kind of pain relief.
None of the patients in the HF10 therapy group experienced paresthesia – a tingling or buzzing sensation often felt with lower frequency stimulators. They were also more likely to be “very satisfied” with their pain relief (55% versus 32%).
Lower back pain affects about a quarter of the world’s adult population and is the leading cause of disability. Back pain is usually treated with physical therapy or pain relievers.
For chronic back pain, spinal cord stimulators are often the treatment of last resort because the devices have to be surgically placed near the spine and connected to batteries implanted under the skin. The devices send electrical impulses into the spine to mask pain.
The Senza SCS system is made by Nevro (NYSE: NVRO), a medical device company based in Menlo Park, California. Senza has been available in Europe and Australia for the last five years. In May, Senza won approval from the FDA for use in the United States.
MarketsandMarkets, a market research firm based in Dallas, estimates the global market for spinal cord stimulators and other neuromodulation devices could reach $6.8 billion by 2017.