The Evoke® System is the First SCS System to Demonstrate Cost-Dominance at Two Years Post-Implant
MINNEAPOLIS, Aug. 4, 2023 /PRNewswire/ — Saluda Medical, Inc. (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced the publication of new health economic data in The Clinical Journal of Pain that provides the strongest ever economic case for the use of Evoke® Closed-Loop SCS with physiologic SmartLoop™ technology over open-loop SCS therapy.
The analysis sought to determine the cost-effectiveness of using the Evoke® System over open-loop SCS for the treatment of chronic intractable pain by examining the costs and outcomes associated with each therapy. Results from the analysis indicate that the Evoke® System becomes cost dominant at 5 years in the base-case analysis and dominant at as early as 2 years post-implant in a scenario analysis.
The analysis was based on results from the Landmark EVOKE Study, which demonstrated the highest reported outcomes in SCS at 36 months with zero explants due to loss of efficacy for patients who received closed-loop therapy. It considered certain costs relating to device list prices and healthcare use for responders, high-responders, and non-responders, as well as explants due to loss of efficacy. This is the first time the impact of the high-responder health state has been reported, and with this data, the Evoke® System becomes the first SCS system to demonstrate cost-dominance as early as two years post-implant in those patients characterized as high-responders.
“This new analysis reinforces the economic case for utilizing devices which have demonstrated long-term therapy durability. Cost-dominance over another therapy at two years is exceedingly rare in medicine, and this reported dominance of the Evoke® System over open-loop SCS should have a profound impact on patients, payors, and hospital systems as they continue to prioritize increased clinical utility at a lower cost,” said Corey Hunter, MD, FIPP, Ainsworth Institute of Pain Management, Assistant Professor, Mt. Sinai Hospital.
“We are committed to elevating SCS therapy with the best science, clinical, and health economic evidence, and the results from this study have set a new standard demonstrating cost-dominance of closed-loop therapy over open-loop therapy,” said Jim Schuermann, President and CEO of Saluda Medical. “We are proud of these results and believe they validate the Evoke® System as a substantial clinical improvement over the current standard of care. In a market that has seen marginal innovation over recent years, this data is one more proof point on the transformational nature Evoke® closed-loop therapy and its potential to drive the SCS market into the future.”
About Saluda Medical
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® System, is the only SmartLoop™ therapy with physiologic ECAP-controlled closed-loop 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 and Evoke are registered trademarks owned by Saluda Medical Pty Ltd.
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