On 6 February 2013, Nevro, a medical device company focused on improving pain relief among patients suffering from debilitating chronic pain, announced the publication of six-month safety and efficacy data from a European study evaluating the company’s Senza High-Frequency Spinal Cord Stimulation system. The Senza system is authorised for sale in Europe and Australia.
The findings were published in Neuromodulation: Technology at the Neural Interface. The 83-patient study evaluated patients with predominant back or leg pain, including a subset of patients who previously failed traditional low-frequency spinal cord stimulation treatment. In the 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% of treated patients, and did so without triggering paresthesia. 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 favourable safety and efficacy profile of Nevro’s High-Frequency Spinal Cord Stimulation system,” said Jean-Pierre Van Buyten, director of the Multidisciplinary Pain Centre at AZ Nikolaas, 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, multicentre European trial enrolled 83 patients with significant back pain. After a trial period, 88% (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%, to 2.7 at six months (p<0.001). Mean leg pain VAS of 5.4 before treatment was reduced 74%, to 1.4 at six months (p<0.001). Of the 72 patients still participating in the European trial at six months, 74% (53 of 72) had greater than 50% back pain relief six months after implantation.
The Senza system delivers Nevro’s HF10 Spinal Cord Stimulation therapy, which provides electrical pulses to the spinal cord at a rate up to 10kHz to reduce the sensation of pain. The electrical pulses are conveyed by small electrodes placed near the spinal cord and connected to a compact battery-powered generator implanted under the skin. Data from this and other European clinical studies suggest that Nevro’s HF10 Spinal Cord Stimulation therapy may offer the ability to treat low back pain and other challenging conditions, including chronic pain patients who do not respond to traditional low-frequency spinal cord stuimulation therapy.
The Senza system is currently the subject of the SENZA-RCT study, a prospective, randomised, controlled pivotal study in the USA to further evaluate the safety and efficacy of Nevro’s Senza system in patients with chronic pain. The unblinded study will enrol up to approximately 300 patients at up to 15 leading pain centres across the USA and will compare its performance against treatment with traditional low-frequency spinal cord stimulation. In the United States, the system is limited by to investigational use and is not available for promotion or sale.