|By Business Wire||
|May 23, 2012 07:01 AM EDT||
Nevro Corp., a medical device company focused on achieving improved pain relief for patients suffering from debilitating chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro’s high-frequency spinal cord stimulation system for the treatment of chronic pain.
Spinal cord stimulation is an established pain treatment that delivers electrical pulses to the spinal cord to mask the transmission of pain signals to the brain. The electrical pulses are delivered by small electrodes that are placed near the spinal cord and are connected to a compact battery powered generator implanted under the skin. While these electrical pulses can reduce pain, they are often associated with unpleasant tingling and buzzing sensations known as paresthesia.
Nevro’s Senza™ High-Frequency Spinal Cord Stimulation (HF-SCS) System delivers similar electrical pulses but at a higher rate than currently available devices. Data from previous European clinical studies suggest that Nevro’s proprietary high-frequency waveform may be effective in treating low back pain and other challenging types of chronic pain that often do not respond to conventional spinal cord stimulation. Data also show that Nevro’s technology can deliver pain relief without paresthesia, which has allowed many patients in countries where the system is available to experience, for the first time, true relief from chronic pain without unpleasant side effects.
“There is a real, unmet need for additional treatment options for chronic pain patients,” said Leonardo Kapural, M.D., Ph.D, medical director of Wake Forest University Health Sciences, Chronic Pain Center in Winston-Salem, N.C., who serves as the principal investigator for the SENZA-RCT trial. “Early studies suggest that high-frequency spinal cord stimulation may expand the group of patients treatable with spinal cord stimulation therapy while eliminating paresthesia, a highly unpleasant side effect of current systems. If these benefits are confirmed in the SENZA-RCT study, Nevro’s high-frequency spinal cord stimulation system could represent an important breakthrough in the management of chronic pain.”
The SENZA-RCT study is a prospective, randomized, controlled pivotal trial that will enroll approximately 300 patients across up to 15 U.S. centers. The study is the first to include active spinal cord stimulation systems in both arms of the trial. Patients will be randomized to receive either Nevro’s high-frequency or conventional low-frequency spinal cord stimulation.
Early Studies Show Promising Results
Clinical research from an earlier, prospective, European study found that high-frequency spinal cord stimulation offered significant and sustained pain reduction in patients with chronic back and leg pain.1 Of the 83 patients enrolled in the study, 87 percent presented with predominant back pain and 81 percent had failed prior back surgery. Patients reported pain using the Visual Analog Scale (VAS), a widely accepted pain measurement scale. Results of the study showed that following treatment with Nevro’s Senza System, average back pain scores dropped from 8.4 at baseline to 2.7 at six-month follow-up, with a median reduction in pain score of 78%. Average leg pain scores were reduced from 5.4 at baseline to 1.4 at six months, with a median reduction of 83%. Pain reduction was sustained out to one year. These results were achieved without patients experiencing paresthesia.
“Results from this initial clinical study suggest high-frequency spinal cord stimulation may be effective in patients who have debilitating back pain, a group that is typically very difficult to treat,” said Jean-Pierre Van Buyten, M.D., chairman of the Multidisciplinary Pain Center AZ Nikolaas Sint-Niklaas, Belgium. “Nevro’s treatment has allowed many of my patients to go from bed rest to a more active life.”
Nevro’s Senza High-Frequency Spinal Cord Stimulation System is authorized for sale in Europe and Australia. In the United States, the product is limited by federal law to investigational use only and is not available for commercial use.
About Chronic Pain
Chronic pain is a widespread and often severely debilitating condition that is estimated to affect more than 100 million adults in the U.S. and to cost the nation up to $635 billion each year in medical treatment and lost productivity.2 Chronic pain is often the result of injury, as with most back pain, or a side effect of disease, as is common among cancer patients. In some cases, patients suffer chronic pain in the absence of trauma. Those suffering from chronic pain often report that pain interferes with every aspect of their lives including work, marriage, parenting, and overall emotional well-being and frequently leads to depression or anxiety. There is no cure for chronic pain and treatment usually requires more than one therapy. In addition to spinal cord stimulation, current therapies to relieve chronic pain include surgery, pharmacology, acupuncture and behavior modification.
About Nevro Corp.
Privately held Nevro Corp., headquartered in Menlo Park, Calif., is the leader in high-frequency spinal cord stimulation for chronic pain. The company’s proprietary high-frequency waveform technology appears to be unique in its potential to effectively treat challenging conditions such as low-back pain while avoiding the unpleasant tingling, buzzing and shocking that can occur with currently available systems. Nevro’s investors include Johnson & Johnson Development Corp, Bay City Capital, Three Arch Partners, Aberdare Ventures, and Accuitive Medical Ventures. For more information visit www.nevro.com.
Senza, Nevro and the Nevro logo are trademarks of Nevro Corp.
1 Smet, et. al., North American Neuromodulation Society Meeting, 2011.
2 Institute of Medicine of the National Academies Report. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, 2011. The National Academies Press, Washington D.C.