Nevro Corp has announced the publication of the SENZA-RCT results in the Online First edition of Anesthesiology, the official Journal of the American Society of Anesthesiologists.
The SENZA-RCT pivotal study was a ground-breaking study that was the first to directly compare spinal cord stimulation (SCS) therapies. The multicenter study compared the safety and effectiveness of HF10 therapy to traditional SCS therapy. The study enrolled 241 patients across 11 US clinical trial sites (171 patients received SCS implants at 10 sites), making it the largest prospective randomised SCS study ever conducted to assess the treatment of chronic back and leg pain.
The Senza SCS system received FDA approval in May of 2015. The results of the SENZA-RCT, first presented at the North American Neuromodulation Society meeting in December of 2014, provided the evidentiary basis for HF10 therapy’s superiority labeling from FDA, a first in the SCS space. Additional information, including 18-month data from the SENZA-RCT, will be presented at the Annual Scientific Meeting of the International Spine Intervention Society on 29 July, 2015.
The full SENZA-RCT publication is available by subscription at http://anesthesiology.pubs.asahq.org/onlinefirst.aspx.
About the Senza System and HF10 Therapy
The Senza system is the only SCS system that delivers Nevro’s proprietary HF10 therapy, an SCS therapy that provides electrical pulses to the spinal cord to alleviate pain. The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered generator implanted under the skin. HF10 therapy is the only SCS therapy indicated to provide pain relief without paresthesia (a stimulation-induced sensation, such as tingling or buzzing, which is the basis of traditional SCS) and is also the first SCS therapy to demonstrate superiority to traditional SCS for back and leg pain in a comparative pivotal study. Nevro’s innovations in SCS, including the Senza system and HF10 therapy, are covered by more than 75 issued US and international patents.