MENLO PARK, Calif., Feb. 6, 2013 /PRNewswire/ -- Nevro Corp., a medical device company focused on improving pain relief among patients suffering from debilitating chronic pain, today announced publication of six-month safety and efficacy data from a European study evaluating the company's Senza ® High-Frequency Spinal Cord Stimulation (HF-SCS) system. The Senza system is presently authorized for sale in Europe and Australia.
The findings were published in Neuromodulation: Technology at the Neural Interface, a peer-reviewed publication of the International Neuromodulation Society. The 83-patient study evaluated patients with predominant back or leg pain, including a subset of patients who previously failed traditional low-frequency SCS treatment. In this challenging cohort, the data demonstrated that the Senza system provided significant and sustained relief for low back pain and leg pain in more than 70 percent of treated patients, and did so without triggering the tingling sensation—known as paresthesia—that is typically associated with traditional low-frequency SCS systems. Patients using the Senza system also experienced significant reductions in pain medication use, significant improvement in their disability, and significant improvement in their ability to sleep.
"The results of this study provide further evidence of the favorable safety and efficacy profile of Nevro's High-Frequency SCS system," said Dr. Jean-Pierre Van Buyten, Director of the Multidisciplinary Pain Centre at AZ Nikolaas in Belgium and lead author of the study. "Patients with intractable back and leg pain are usually desperate for relief and for a solution that will allow them to resume a normal life. I have seen firsthand with my own patients the vast improvements in quality of life that Nevro's system has provided."
The prospective, open-label, multicenter European trial enrolled 83 patients with significant back pain. After a trial period, 88 percent (72 of 82) of patients reported a significant improvement in Visual Analog Scale (VAS) pain scores and underwent permanent implantation of the Senza system. For patients receiving permanent implants, mean back pain VAS of 8.4 before treatment was reduced 68 percent, to 2.7 at six months (p<0.001). Mean leg pain VAS of 5.4 before treatment was reduced 74 percent, to 1.4 at six months (p<0.001). Of the 72 patients still participating in the European trial at six months, 74 percent (53 of 72) had greater than 50 percent back pain relief six months after implantation.