-- European Data Provide Evidence of Safety, Efficacy and Paresthesia-Free Pain Relief in a Difficult-to-Treat Population
MENLO PARK, California, 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.
The Senza system delivers Nevro's HF10™ SCS therapy, which provides electrical pulses to the spinal cord at a rate up to 10 kHz 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 SCS 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 SCS therapy.
The Senza system is presently the subject of the SENZA-RCT study, a prospective, randomized, controlled pivotal study in the United States to further evaluate the safety and efficacy of Nevro's Senza system in patients with chronic pain. The unblinded study will enroll up to approximately 300 patients at up to 15 leading pain centers across the U.S. and will compare its performance against treatment with traditional low-frequency SCS. In the United States, the system is limited by federal law to investigational use and is not available for promotion or sale.
About Nevro Corp.
Headquartered in Menlo Park, California, privately held Nevro Corp. is focused on the development and commercialization of high-frequency spinal cord stimulation (HF-SCS) for the treatment of chronic pain and other disorders. The company has developed the Senza HF-SCS system, only SCS system capable of delivering stimulation of up to 10 kHz and providing HF10 SCS therapy. The company's proprietary high-frequency waveform technology appears unique in its potential to effectively treat challenging conditions such as low back pain while enhancing patient experience. Nevro's investors include Aberdare Ventures, Accuitive Medical Ventures, Bay City Capital, Johnson & Johnson Development Corporation, MPM Capital, and Three Arch Partners. For more information, please visit www.nevro.com.
Senza, HF10, Nevro and the Nevro logo are trademarks of Nevro Corp.
Caution – Investigational device, limited by United States law to investigational use.
Nicole Osmer (U.S.)
Mike Sinclair (UK)
Tel: 020 7318 2955
SOURCE Nevro Corp.