IMMPACT recommendations for spinal cord stimulation randomized controlled trials established holistic patient outcomes evidence beyond pain relief
EVOKE study is the first randomized controlled trial in spinal cord stimulation to demonstrate that 100% of patients were clinically significant responders in at least one patient outcome measure
ARTARMON, Australia, July 19, 2022 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical"), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by breakthrough proprietary neural sensing technology, announced Steven M. Falowski, MD, presented late-breaking 24-month data from the Landmark EVOKE study at the 2022 American Society of Pain and Neuroscience (ASPN) fourth annual meeting. The evidence presented at ASPN was the first time a company has published data from a pivotal randomized controlled trial (RCT) capturing pain relief as well as quality of life, functional status, sleep, and mood improvements. Together with pain relief, these outcome measures constitute "holistic outcomes."
Historically, patients prescribed a spinal cord stimulator have been evaluated primarily on pain reduction or responder rate (>50% pain relief). Chronic pain is complex and can affect virtually all parts of a patient's life. Three professional societies that are part of a larger consortium – Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), Institute of Neuromodulation (IoN), and International Neuromodulation Society (INS) – recently published recommendations suggesting patient outcomes should be evaluated as a composite measure beyond just pain relief and include functional ability, sleep, quality of life, and mood for a more complete assessment of an individual's response to spinal cord stimulation.
"It is well understood that chronic pain is dynamic and often multidimensional," said Robert M. Levy MD, PhD, Editor in Chief of the journal Neuromodulation: Technology at the Neural Interface, Immediate Past President of the International Neuromodulation Society (INS), and author on IMMPACT recommendations published in PAIN the journal. Dr. Levy is also a retired Professor of Neurosurgery and Physiology at the Feinberg School of Medicine at Northwestern University and former Chairman of the Department of Neurosurgery and Co-Director of the Neuroscience Institute at the University of Florida College of Medicine. "Clinicians have relied on relatively subjective measures such as a patient's verbal pain rating, and we recognize the need for more objective assessments that give a more complete picture of patient outcomes. The consortium's recommendation is to assess spinal cord stimulation trial outcomes on a more holistic manner that is more reflective of the chronic pain experience."
Saluda Medical's Evoke® System is the first and only smart spinal cord stimulator that can sense and measure the spinal cord's response to stimulation. Powered by SmartLoop™ Technology, Evoke® can automatically adjust therapy more than 4 million times per day to deliver consistent neural activation based on the patient's unique neural signature. Long-term evidence presented at ASPN demonstrated 100% of patients treated with Evoke® smart stimulation were clinically significant responders in at least one outcome measure of pain relief, function, sleep, quality of life, or mood. Additionally, nearly 1 in 2 Evoke® smart stimulation patients displayed a holistic outcome response which included clinically significant improvements in all five domains.
"Dr. Falowski referenced in his presentation that the multidimensional aspects of chronic pain disease require a holistic outcomes assessment," said Jim Schuermann, CEO and President, Saluda Medical. "Saluda is the first to follow the IMMPACT, IoN, and INS established recommendation for a more complete outcome assessment. No other company has published enduring patient outcomes out to 24-months in a pivotal randomized controlled trial capturing pain relief as well as quality of life, functional status, sleep, and mood improvements as a composite measure."
Katz, N., et al. (2021). Research design considerations for randomized controlled trials of spinal cord stimulation for pain: Initiative on methods, Measurement, and pain assessment in clinical trials/Institute of Neuromodulation/International Neuromodulation Society recommendations. Pain, 162(7), 1935–1956. https://doi.org/10.1097/j.pain.0000000000002204
Saluda Medical is a global company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by breakthrough proprietary neural sensing technology. The company's first product, the Evoke® System, is the only smart spinal cord stimulation (SCS) system and is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. The Evoke® System instantaneously reads, records, and responds to the nerves' response to stimulation to provide continually optimized therapy and is proven to be superior to open-loop SCS for the treatment of overall trunk and/or limb pain. 12-month results from the EVOKE study, the first double-blind randomized controlled trial (RCT) used in support of Premarket Approval (PMA) in spinal cord stimulation history, were published in The Lancet Neurology and 24-month results have since been published in JAMA Neurology. Both publications are poised to set new clinical standards for long-term pain relief and improvements in physical and emotional functioning, sleep quality and health-related quality of life. Furthermore, there is promising data to show the Evoke® System demonstrated a reduction in re-programming visits over time as well as an elimination of explants due to loss of efficacy out to 24-months – which are significant challenges with current SCS therapies. To learn more, including risks & important safety information, visit www.saludamedical.com.
Saluda Medical and Evoke are registered trademarks owned by Saluda Medical Pty Ltd.
SOURCE Saluda Medical