Saluda Medical Pty Limited (“Saluda Medical”), a global company on a mission to revolutionize the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders, today announced long-term results of its double-blind Level 1 EVOKE randomized controlled trial (RCT) published online in JAMA Neurology. This follows the 12-month EVOKE Study results previously published in The Lancet Neurology. The EVOKE Study is the first double-blind, pivotal RCT in spinal cord stimulation (SCS) and includes the longest follow-up period of any SCS study with follow-up out to 36 months.
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The study is the first to evaluate the effectiveness of ECAP-controlled closed-loop SCS compared to open-loop SCS. The limitation of open-loop SCS systems is the lack of adjustment to the broad range of electrical field strength reaching the spinal cord due to changes in distance between the stimulation electrode and the nerves. These changes in distance are caused by normal physiological activity (e.g., breathing and heartbeat) and movement, which results in variable nerve activation. The Evoke® System is designed to address these limitations through consistently optimizing therapy dosing and pain relief by instantaneously measuring and adjusting stimulation at the microsecond level through proprietary ECAP-controlled closed-loop SCS technology. Evoke is an investigational device in the U.S. and is limited by federal law to investigational use. Evoke is not approved or available for sale in the U.S until it receives approval by the FDA.
The two-year results demonstrate that Evoke closed-loop 12-month superior pain relief results were sustained out to 24 months and that Evoke closed-loop patients exhibit greater long-term improvements in patient-reported outcomes than open-loop patients, with quality-of-life improvements nearing normative values for the U.S. population despite the severity of baseline chronic pain. The Evoke closed-loop primary and secondary outcomes are as well as or better than outcomes presented in any previously conducted RCT spinal cord stimulation evidence at 24 months and demonstrate that Evoke closed-loop patients experience improvements across many aspects of their health, with a majority experiencing clinically important differences in functional ability, quality of life, sleep, and mood with meaningful reduction in opioid use.1
Significant findings of Evoke ECAP-controlled closed-loop in the EVOKE Study at 24 months include:
Superiority in treatment of overall back and leg pain and long-term pain reduction
Highest long-term responder (≥50% relief) and high responder (≥80% relief) rates, 84% and 50%, respectively
Highest reported improvements in overall quality of life, pain relief, ability to perform daily activities, sleep quality, mood, and opioid reduction2
Statistically significant higher degree of spinal cord activation maintained within the therapeutic window (94% vs 46% for open-loop SCS)
Quality of life improvements were better than other chronic pain treatments, such as lumbar decompression and fusion, and rival distinguished interventions for other conditions such as hip and knee arthroplasty
Nearly 7 out 10 patients (66.7%) voluntarily reduced or eliminated opioids
No explants due to loss of efficacy†
In addition to these findings, the study demonstrated that Evoke closed-loop demonstrated a near elimination of reprogramming visits after 12 months saving clinician and clinic time for additional patient care.
“In my view, the EVOKE Study has demonstrated through rigorous clinical evidence that Evoke ECAP-Controlled Closed-Loop Spinal Cord Stimulation is poised to provide chronic pain patients with a remarkable opportunity to improve their total health and live a pain-free life,” said Nagy Mekhail, MD, PhD, Professor at the Cleveland Clinic Lerner College of Medicine, Director of Evidence-Based Pain Medicine Research and Education in the Department of Pain Management at the Cleveland Clinic, and lead author and medical monitor for the EVOKE Study. “These unprecedented outcomes have the potential to set new clinical standards for chronic pain treatment, and I believe the results are due to the Evoke System’s novel technology which is designed to instantaneously measure the spinal cord’s response to stimulation and automatically adjust to maintain consistent therapy in and out of the clinic.”