Saluda Medical has announced the US Food and Drug Administration (FDA) approval of 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 systems in patients in the USA, according to the company.
Saluda states in a recent press release that EVA is designed to improve the SCS patient programming experience by automating manual programming steps, and autonomously scanning and analysing a patient’s nerves to optimise therapy settings. This automated programming workflow has the potential to minimise 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 release also details.
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 (The Spine and Nerve Center of the Virginias/West Virginia University [WVU] School of Medicine, Morgantown, USA). “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.”
Saluda notes in its recent release that clinical data on EVA will be presented at the upcoming North American Neuromodulation Society (NANS) annual meeting (30 January–1 February, Orlando, USA), with further insights into the platform’s impact on patient programming set to be shared.
“We witnessed the sophisticated therapy optimisation 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 (Evolve Restorative Center, Santa Rosa, USA), principal investigator of the Prospective Dose-Controlled Closed-Loop study.
Earlier this month, Saluda also announced the closing of US$100 million in financing, stating in a separate press release that net proceeds would primarily be used to advance the commercialisation of the Evoke SCS system.
