ARTARMON, Australia, Jan. 20, 2021 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical"), the market leader in the development of closed-loop spinal cord stimulation for the treatment of chronic pain, announced scientific highlights from the 2021 North American Neuromodulation Society (NANS 2021) Virtual Meeting, including real-world European commercial results and sub-analyses of 24-month and 12-month clinical data from the Avalon Australian Study and EVOKE investigational device exemption (IDE) Pivotal Study. Additionally, a record number of posters and presentations at NANS 2021 were focused on evoked compound action potential (ECAP, the patient's unique spinal cord response to electrical stimulation) recordings for spinal cord stimulation (SCS).
"As the pioneers in closed-loop spinal cord stimulation, we are thrilled to see the growing body of clinical evidence demonstrating the power of ECAPs," said John Parker, Founder and CEO. "Through the use of our real-time closed-loop control, we have a deep proprietary pipeline to improve upon the robust results as peer reviewed in The Lancet Neurology."
Saluda was gratified to see posters by a new group presenting preliminary research with ECAPs, which confirmed Saluda's early findings that closed-loop control with ECAPs is needed to cope with physiologic changes that occur in everyday life – such as positional movements, coughing, and heart rate – to reliably and consistently deliver SCS therapy. Saluda's proprietary Evoke System is the only closed-loop SCS system designed to provide real-time customization of waveforms to each unique ECAP, which can be updated more than 100 times a second, designed to deliver consistent therapy within a patient's individual therapeutic window.
The EVOKE Study is the first and only randomized, controlled, double-blind pivotal study in SCS and is the first-ever SCS study to be published in The Lancet Neurology. Published results demonstrated statistical superiority for the closed-loop treatment arm against the open-loop control arm, which used traditional fixed-output SCS.1 Saluda's Evoke is the only closed-loop SCS system to have presented data on devices fully implanted in humans, to date.
"Saluda Medical has invested in rigorous clinical science and engineering development in order to make physiologically controlled SCS possible," commented Lawrence Poree, MD, PhD, MPH, Professor and Director of the Pain Management Neuromodulation Service at the University of California at San Francisco and presenter on closed-Loop clinical evidence during NANS 2021. "The highest bar is needed to validate closed-loop SCS therapies, and I applaud the scientists and clinician researchers who have dedicated themselves to the advancement of new neuromodulation therapies in pain management."
Key Presentation and Poster Highlights from NANS 2021:
Dr. Charles Brooker presented on a new comprehensive analysis of Avalon 24-month data that showed 82.8% of patients reduced or eliminated opioids at 24 months and 41% were on 0 milligrams of morphine equivalents (MMEs). Patients in the study reported an average of 81.2% overall pain relief and 4 out of 5 patients had a clinically significant improvement in quality of life at 24 months.2
Dr. Nagy Mekhail presented a deep dive into the functional improvements and high responder data in the EVOKE RCT at 12 months, which demonstrated high levels of pain relief (89.1% responders) in parallel with high rates of mental health improvement (62% with minimally clinical important difference – MCID), quality of life improvement (86% with MCID), functional disability improvement (80% with MCID), quality sleep improvement (76% with MCID), and voluntary opioid reduction (54.8% reduced or eliminated).3
Dr. Shrif Costandi presented on the Interconnectivity of Sleep and Pain highlighting nearly 2x the MCID in sleep improvement in the closed-loop arm in the EVOKE RCT, which equated to reporting more than 1 hour extra per night.4
During an invited presentation, titled Can Closed-Loop Therapy Obviate Frequent Reprogramming, Dr. Lawrence Poree explained how setting up a feedback loop using ECAP measurement may lead to long-term sustainability of the therapy and reduce the need for re-programming.5
Dr. Harold Nijhuis presented on the European real-world experience from the first patients implanted in the Netherlands and reported 92% of patients were responders long term.6
Dr. Rui Duarte and Dr. Sean Li presented on complimentary research and showed ECAP-based SCS health economic evaluations to have HRQoL (health-related quality of life) rates that rival common interventional therapies.7,8
EVOKE Study data at 12 months demonstrated pain relief was independent of paresthesia and nearly 30% of patients were below perception. Dr. Timothy Deer presented that ECAP-based closed-loop SCS resulted in high rates of pain relief regardless of paresthesia.9
Dr. Hunter concluded that maintaining twice the level of spinal cord activation (95.2% CL vs. 47.9% OL), while remaining in the therapeutic window, is the basis for the statistical superiority of closed-loop in the EVOKE Study. He also noted that the therapeutic window in patients treated with open-loop stimulation shrunk overtime as they spent more time subthreshold.10
About Saluda Medical
Saluda Medical is a global neuromodulation company leading the development and commercialization of data-driven, personalized therapies for patients with chronic pain. The company's first product, Evoke®, is a closed-loop spinal cord stimulation (SCS) system designed to treat chronic pain, a condition that affects more than 540 million people globally. SCS treats the condition by stimulating the spinal cord and altering the transmission of pain signals to the brain. Evoke is designed to optimize pain relief by measuring and recording each patient's unique response to stimulation, and is designed to make millions of real-time adjustments per day to maintain a consistent level of therapy delivery for each patient and avoid periods of over- and under-stimulation that have historically challenged the performance of other SCS devices. To learn more, visit www.saludamedical.com and connect with us on LinkedIn at www.linkedin.com/company/saluda-medical/.
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.
Evoke and Saluda are registered trademarks of Saluda Medical.
Mekhail N, Levy RM, Deer TR, et al. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomized, controlled trial. Lancet Neurol. 2020;19(2):123-134. Presented at the 2021 North American Neuromodulation Society Virtual Meeting (15-16 Jan 2021):
Brooker, C. et al. 24-Month Avalon Study Data Indicates Improved Pain Reduction with Decreased Opioid Use.
Mekhail, N. et al. Closed-Loop SCS: EVOKE RCT Long-Term & Secondary Outcomes at 12 Months.
Costandi, S. et al. Interconnectivity of Sleep and Pain: Long-Term Objective Sleep Quality Improvements with Closed-Loop Spinal Cord Stimulation.
Poree, L. Can Closed-Loop Therapy Obviate Frequency Re-Programming.
Nijhuis, H. et al. Early Results of First Patients Treated with ECAP-Controlled Closed-Loop Spinal Cord Stimulation in the Netherlands.
Duarte, R. et al. Health-Related Quality of Life Associated with Pain Health States in Spinal Cord Stimulation for Chronic Neuropathic Pain.
Li, S. et al. Normalizing Qualify of Life by Achieving High Responder Rates: Sub-Analysis from the EVOKE Study High Responders from the EVOKE Closed-Loop SCS Clinical Trial.
Deer, T. et al. Closed-Loop Stimulation Minimizes Anatomical and Physiological Variability in SCS, Leading to improved Long-Term Superiority.
Hunter, C. et al. Using Evoke Compound Action Potentials to Determine Therapeutic Window and Maintain Long-Term Stability of SCS.