Saluda Medical has announced that Steven Falowski (Argires-Marotti Neurosurgical Associates of Lancaster, Lancaster, USA) recently presented late-breaking 24-month data from the company’s EVOKE study at the 2022 American Society of Pain and Neuroscience (ASPN) annual meeting (14–17 July, Miami Beach, USA).
According to Saluda, the evidence presented at ASPN 2022 marks the first time a company has published data from a pivotal randomised 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”, as per a press release.
Historically, patients prescribed spinal cord stimulation (SCS) 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 SCS.
“It is well understood that chronic pain is dynamic and often multidimensional,” said Robert Levy (Marcus Neuroscience Institute, Boca Raton, USA), editor-in-chief of the journal Neuromodulation: Technology at the Neural Interface, immediate past-president of the INS, and author on IMMPACT recommendations published in the journal Pain. “Clinicians have relied on relatively subjective measures, such as a patient’s verbal pain rating, and we recognise the need for more objective assessments that give a more complete picture of patient outcomes. The consortium’s recommendation is to assess SCS trial outcomes on a more holistic manner that is more reflective of the chronic pain experience.”
Saluda claims that its 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 four million times per day to deliver consistent neural activation based on the patient’s unique neural signature.
Long-term evidence presented at ASPN 2022 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 one in two Evoke smart stimulation patients displayed a holistic outcome response which included clinically significant improvements in all five domains, according to the release.
“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. “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 RCT capturing pain relief as well as quality of life, functional status, sleep and mood improvements as a composite measure.”