Nevro Corp. Announces Publication of 24-month European Clinical Data on HF10 Spinal Cord Stimulation (SCS) Therapy for Chronic Back and Leg Pain Long-term Results Published in the Journal Pain Medicine in Study of Sustained Efficacy and Safety
MENLO PARK, Calif., March 11, 2014 /PRNewswire/ -- Nevro Corp. announced today that the 24 month results of a prospective European clinical study using Nevro's Senza® system delivering HF10™ therapy were published in the journal Pain Medicine. The study was conducted in the United Kingdom and Belgium with 65 of the 72 implanted patients (90%) being available for data collection at two years, representing an excellent follow-up rate.
This clinical study evaluated the long-term safety and efficacy of HF10 therapy in patients with difficult-to-treat chronic, retractable low back and leg pain. At baseline, 86% of the patients included in the 24 month analysis had primary back pain and 79% had failed back surgery syndrome. After two years of HF10 therapy, the mean baseline back pain score of 8.4 out of 10.0 was reduced to 3.3 (P < 0.001). The mean baseline leg pain score of 5.4 out of 10.0 was reduced to 2.3 (P < 0.001). The mean dosage of oral morphine equivalents per patient decreased from 84 mg/day to 27 mg/day (P < 0.001). Disability and sleep disturbances were also significantly reduced. The safety profile of HF10 therapy was comparable to traditional SCS in terms of type and rates of complications.
The Senza system is presently the subject of the SENZA-RCT pivotal study, a landmark prospective, randomized, controlled study in the United States to evaluate the safety and efficacy of Nevro's Senza system in patients with chronic pain. The SENZA-RCT study is the first pivotal RCT in the history of SCS and the only randomized study with a head-to-head comparison of SCS systems. Nevro announced completion of enrollment in the study in March 2013, with 241 patients enrolled over a seven month period at eleven leading pain centers across the United States. Patients were randomized to receive either the Senza system or a traditional low-frequency SCS system.
About the Senza system
Nevro's Senza® system delivers HF10™ therapy, an advanced spinal cord stimulation therapy that provides electrical pulses to the spinal cord at a rate up to 10,000 per second (10 kHz), as compared to traditional low-frequency SCS therapy, which usually deliver the electrical pulses at less than 100 pulses per second for chronic back and leg pain. The electrical pulses are conveyed by small electrodes placed in the epidural space and connected to a compact battery-powered generator implanted under the skin. The Senza system utilizes a rechargeable battery and has achieved a CE Mark labeling for a 10 year battery life.
The Senza system is authorized for sale in Europe and Australia and is supported by European data published in Pain Medicine and Neuromodulation: Technology at the Neural Interface. In the United States, the system is limited by federal law to investigational use only and is not available for sale.
About Nevro Corp.
Headquartered in Menlo Park, California, privately held Nevro Corp. is focused on the development and commercialization of high frequency stimulation for the treatment of chronic pain and other disorders. Nevro's investors include Aberdare Ventures, Accuitive Medical Ventures, Bay City Capital, Covidien Ventures, Johnson & Johnson Development Corporation, MPM Capital, New Enterprise Associates, Novo Ventures, and Three Arch Partners.
Senza, HF10, Nevro, and the Nevro logo are trademarks of Nevro Corp.
SOURCE Nevro Corp.