Saluda Medical Wins FDA Nod for Automated SCS Programming Platform

Saluda Medical has earned U.S. Food and Drug Administration (FDA) approval for its biomarker-based, automated patient programming platform in spinal cord stimulation (SCS).

The new EVA programming platform is compatible with commercially implanted Evoke system patients in the U.S.

EVA automates manual programming steps and autonomously scans and analyzes the nerves to optimize therapy settings. Saluda said the automated programming could minimize care burden by reducing the time element of programming and elevating the patient’s experience. It can also improve daily clinic throughput in busy pain practices, the company said.

The EVA platform senses, measures, and adjusts stimulation based on a patient’s unique biomarker response. This is 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.”

“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,” added Jason Pope, MD, principal investigator of the Prospective Dose-Controlled Closed-Loop Study, and founder and CEO, Evolve Restorative Center.

The Evoke SCS system was awarded MRI conditional labeling in September 2023.