MENLO PARK, Calif.--()--Nevro Corp., a medical device company focused on improving pain relief among patients suffering from debilitating chronic pain, today announced completion of enrollment in the SENZA-RCT U.S. pivotal study, designed as the largest prospective, randomized, controlled pivotal study in spinal cord stimulation (SCS) to date.
“The large pool of prospective patients allowed us to expeditiously identify appropriate candidates for the study. I believe the quick enrollment is indicative of the prevalence of potential patients suffering from chronic, intractable pain of the back and legs and in need of therapy.”
The SENZA RCT study is intended to evaluate the safety and efficacy of the Nevro® Senza® High-Frequency Spinal Cord Stimulation (HF-SCS) System in patients with chronic, intractable pain of the back and legs. The study enrolled 241 patients over a seven-month period at 11 leading pain centers across the U.S. Patients were randomized to receive either the Senza HF- SCS system or a traditional low-frequency SCS system.
“The pace of patient enrollment in the SENZA-RCT exceeded our expectations,” said Leonardo Kapural, M.D., the study’s principal investigator, from the Carolinas Pain Institute in Winston-Salem, North Carolina. “The large pool of prospective patients allowed us to expeditiously identify appropriate candidates for the study. I believe the quick enrollment is indicative of the prevalence of potential patients suffering from chronic, intractable pain of the back and legs and in need of therapy.”
The Senza system delivers Nevro’s HF10™ SCS therapy, which 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 systems that usually deliver therapy at less than 100 pulses per second for chronic back- and leg-pain patients. 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.
Nevro’s Senza HF-SCS System is authorized for sale in Europe and Australia and is supported by the recent publication in Neuromodulation: Technology at the Neural Interface of six-month data from Nevro’s European Study. 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 HF-SCS 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. 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.