Saluda Medical has secured FDA approval for its innovative EVA platform, an automated patient programming system for spinal cord stimulation (SCS). This advancement promises to streamline SCS therapy by automating manual programming steps and optimizing therapy settings based on individual patient needs. The approval marks a significant step forward in the treatment of chronic pain through neuromodulation.
The EVA platform is designed to work with all commercially implanted Evoke® System patients in the U.S. Its core innovation lies in its ability to sense, measure, and adjust stimulation using evoked compound action potentials (ECAPs), a biomarker response unique to each patient. This allows for a personalized approach to pain management, potentially improving outcomes and reducing the burden of care.
Streamlining SCS Programming
Traditional SCS programming can be a time-consuming process, requiring manual adjustments and patient feedback to optimize stimulation parameters. EVA automates this process, autonomously scanning and analyzing a patient's nerves to determine the most effective therapy settings. According to Saluda Medical, this automated workflow has the potential to substantially reduce programming time and improve clinic throughput.
"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."
Clinical Validation and Future Presentations
The clinical efficacy and efficiency of EVA will be further explored at the North American Neuromodulation Society (NANS) Annual Meeting, scheduled for January 30 – February 1, 2025, in Orlando, FL. Researchers will present data on the platform's impact on patient programming and outcomes.
Jason Pope, MD, principal investigator of the Prospective Dose-Controlled Closed-Loop Study, and Founder and CEO, Evolve Restorative Center, noted, "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."
Market Impact and Future Directions
Saluda Medical's recent closing of US$100 million in financing will support the commercialization of the Evoke SCS system and the rollout of the EVA platform. This FDA approval positions Saluda Medical as a key player in the neuromodulation space, offering a potentially more efficient and personalized approach to spinal cord stimulation for chronic pain management.
