Jan 17, 2023, 09:00 ET
Unprecedented Long-Term SCS Study Data Demonstrates Sustained Superiority of Evoke® Closed-Loop
No Explants Due to Loss of Efficacy at 36 Months
Cross-Over Cohort to Closed Loop Improved in Pain Relief and Holistic Response
ARTARMON, Australia, Jan. 17, 2023 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical"), a global medical device company revolutionizing the field of neuromodulation, today announced that late-breaking data from the landmark EVOKE Clinical Trial was presented at the 2023 North American Neuromodulation Society (NANS) Annual Meeting. The data presented is the longest follow-up evidence from a US IDE trial in spinal cord stimulation (SCS) history.
The Intention-to-Treat (ITT) and crossover analysis of the 134 randomized patients across 13 U.S. sites in this 36-month, double-blind, randomized controlled trial (RCT) was presented by Nagy Mekhail, MD, PhD, Professor of Anesthesiology, Carl Wasmuth Chair and Director, Evidence-Based Pain Management Research at the Cleveland Clinic during the Late-Breaking Clinical Abstracts Session. The long-term data set demonstrated patients receiving the closed-loop arm (Evoke® SmartSCS™ System) experienced clinical outcomes never before reported in SCS:
- Sustained superiority over open loop in treating overall back and leg pain
- 78% of ITT (83% of implanted closed-loop patients) achieved >50% pain reduction
- 49% of ITT (59% of implanted closed-loop patients) achieved >80% pain reduction
- 0 explants due to loss of efficacy after 36 months of closed-loop therapy
- High patient satisfaction: 90% very satisfied or satisfied
While blinded to whether they were receiving closed-loop or open-loop therapy, patients were able to cross over to the other treatment arm at 24 months and then decide which arm they preferred. The majority of patients who crossed over from open-loop to closed-loop therapy chose to cross over in search of better pain relief. Importantly, 9 out of 10 patients treated with closed-loop at any time completed the study in the closed-loop arm.
In addition to experiencing significant and durable pain relief, blinded patients who crossed over to closed-loop experienced improvements in multiple dimensions of patient outcomes including quality of life, functional ability, mood, and sleep at 36 months, achieving a similar level of treatment benefit as the blinded patients who had stayed in closed-loop therapy the entire 36 months.
"The Evoke® System is the only SCS therapy capable of continuously listening to the spinal cord and optimizing neural activation with precise, prescriptive closed-loop dosing based upon an individual patient's unique neural signature. We can now see how much patients benefited from more consistent activation of the spinal cord, which is something we were previously unable to do with other SCS systems," said Nagy Mekhail. "Equally compelling is the Evoke® System's ability to deliver a more enduring solution to pain, highlighted by zero explants due to loss of efficacy through 36 months, something we have not seen before. This is one of the most important innovations in the field of neuromodulation since Norman Shealy implanted the first stimulator lead in 1967."
"We sincerely thank our clinical investigators and patients who have partnered with us to pioneer the science and evidence for this new enduring treatment for chronic pain," said Jim Schuermann, President and CEO of Saluda Medical. "This unprecedented data set strongly validates the recent recognition by CMS that the Evoke System represents a substantial clinical improvement over current standard of care, and we believe there is significant interest in this innovative new treatment option for patients seeking long-term pain relief."
Saluda Medical is a global company transforming patients' lives with disruptive neural sensing technologies designed to revolutionize the field of neuromodulation. The company's first product, the Evoke® SmartSCS™ System, is the only ECAP-controlled closed-loop 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 automatically reads, records, and responds to the nerves' response to stimulation 4+million times a day 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. Furthermore, unprecedented 36-month data from the EVOKE Study demonstrated enduring and consistent pain relief with the Evoke System. To learn more, including risks & important safety information, visit www.saludamedical.com/us/safety/.
Saluda Medical and Evoke are registered trademarks owned by Saluda Medical Pty Ltd.
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SOURCE Saluda Medical
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