Saluda Medical Receives FDA Approval for First Automated Programming Platform in SCS

MINNEAPOLIS, Jan. 23, 2025 /PRNewswire/ -- Saluda Medical, Inc., a pioneer in the development and commercialization of a novel neuromodulation platform designed to transform the lives of patients with chronic neurological conditions, today announced United States (U.S.) Food & Drug Administration (FDA) approval for its biomarker-based, automated patient programming platform in spinal cord stimulation (SCS), representing a significant advancement for SCS therapy.

The new programming platform, EVA™, is compatible with all commercially implanted Evoke® System patients in the U.S.

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.

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 (ECAPs).

“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, President and CEO, The Spine & Nerve Center of the Virginias, and Clinical Professor of Anesthesiology and Pain Medicine, WVU School of Medicine. “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.”

Sign up for Blog Updates