FEBRUARY 4, 2025
The FDA has approved EVA (Saluda), a biomarker-based, automated patient programming platform in spinal cord stimulation (SCS), compatible with all commercially implanted Evoke System patients in the United States.
EVA is designed to improve the SCS patient programming experience by automating manual programming steps and autonomously scanning and analyzing a patient’s nerves to optimize therapy settings.
“This automated programming workflow has the potential to minimize the
The FDA has approved EVA (Saluda), a biomarker-based, automated patient programming platform in spinal cord stimulation (SCS), compatible with all commercially implanted Evoke System patients in the United States.
EVA is designed to improve the SCS patient programming experience by automating manual programming steps and autonomously scanning and analyzing a patient’s nerves to optimize therapy settings.
“This automated programming workflow has the potential to minimize the burden of care by substantially reducing the time element of programming and elevating the overall patient experience, while simultaneously improving daily clinic throughput in busy pain practices,” according to the company in a press release.
The innovation behind EVA is powered by sensing, measuring and adjusting stimulation based on each patient’s unique biomarker response, known as evoked compound action potentials.
“With the added benefit of an automated programming workflow, the Evoke System is better positioned to transform the SCS category than ever before,” said Timothy Deer, MD, the president and CEO of The Spine and Nerve Center of the Virginias in Charleston, W.Va., and a clinical professor of anesthesiology and pain medicine at West Virginia University School of Medicine, in Morgantown. “EVA has the potential to usher in new benefits for clinicians and staff with greater ease of use, faster and more consistent programming, and monitoring physiological data to adjust settings to an optimal therapeutic dose.”
Clinical data on EVA were presented at the annual North American Neuromodulation Society 2025 Annual Meeting, in Orlando, Fla.
“We witnessed the sophisticated therapy optimization of EVA occur in less than 13 minutes, the benefits of which could have a tremendous impact on improving patient outcomes while simultaneously increasing clinic efficiencies,” said Jason Pope, MD, the principal investigator of the Prospective Dose-Controlled Closed-Loop study, and founder and CEO of Evolve Restorative Center.
Based on a press release from Saluda.
