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Saluda Medical Announces Publication of 24-Month Spinal Cord Stimulation Results with the Evoke® SystemARTARMON, Australia, May 10, 2021 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical"), the market leader in the development of closed-loop spinal cord stimulation (SCS) for the treatment of chronic pain, today announced the publication of 24-month results from the prospective, multicenter, open-label Avalon Study in Pain Practice, the official journal of the World Institute of Pain. The study is the world's first multicenter spinal cord stimulation study to demonstrate these levels of profound pain relief scores and functional outcome measures at 24 months highlighting the restorative benefits for patients implanted with Saluda's proprietary Evoke® Spinal Cord Stimulation (SCS) System. The published results can be accessed here: ECAP–Controlled Closed–Loop Spinal Cord Stimulation Efficacy and Opioid Reduction over 24–Months: Final Results of the Prospective, Multicenter, Open–Label Avalon Study In publishing these results, Evoke has set a new standard for clinical studies of SCS therapy evaluating patients through 24 months. Outcome measures in the Avalon Study approached normal levels in quality of life scores while reducing or eliminating opioids in most patients. Importantly, zero patients were explanted due to loss of efficacy and re-programming visits steadily declined over the course of the study. "The 24-month data from the Avalon Study continues to highlight the Evoke Closed-Loop System's ability to restore patients' lives," said Dr. Charles Brooker, Director of the Pain Management and Research Centre, Royal North Shore Hospital, New South Wales, Australia, and lead author on the 24-month publication, "The investigators' and patients' experience suggests Saluda's closed-loop technology could be an alternative or replacement to opioids in chronic backand leg pain patients. I feel the profound pain relief and functional, quality of life, and sleep improvements demonstrated indicate Evoke has become one of the most important tools in our armamentarium to treat chronic pain." Saluda is pioneering the field of closed-loop SCS with the introduction of the Evoke System, which is designed to provide real-time customization of waveforms to each patient's unique ECAP at the same rate as the stimulation frequency (>100 times per second).1 The Evoke Closed-Loop System is designed to provide consistent therapy within a patient's preferred levels and avoid periods of over and under-stimulation. Important Avalon Study 24-month highlights include:
"Our mission is to transform the lives of patients living with chronic neuropathic pain by equipping our therapy with the most advanced measurement and response technology. We believe this will translate into breaking down barriers due to cost, service burden, and invasiveness thus ensuring broad patient access," said Jim Schuermann, CEO of Saluda Medical. "The Avalon Study demonstrates to the clinical community the long-term outcomes that can be achieved with the Evoke Closed-Loop SCS System. We'd like to thank all the Avalon investigators, clinical coordinators, nurses, their teams, and our patients for supporting Saluda in this important study." 1. *Data on file. Individual patient frequency ranges vary. About the Avalon Study CAUTION: Evoke® is an investigational device in the United States. Evoke is limited by Federal (or United States) law to investigational use. It is not available for sale in the United States. About Saluda Medical View original content to download multimedia:http://www.prnewswire.com/news-releases/saluda-medical-announces-publication-of-24-month-spinal-cord-stimulation-results-with-the-evoke-system-301287381.html SOURCE Saluda Medical |