US-based medical equipment manufacturer Saluda Medical has announced the full US launch of its EVA sensing technology, designed for use with the Evoke SmartLoop System.
The technology, which received US Food & Drug Administration (FDA) approval in December 2024, aims to enhance patient outcomes.
It works by delivering personalised therapy through precise spinal cord analysis.
EVA extends the capabilities of the Evoke System by objectively scanning and analysing a patient’s spinal cord.
The technology optimises patient outcomes by sensing, measuring, and adjusting stimulation based on the patient’s neural response biomarker.
The biomarker, known as the evoked compound action potential (ECAP), ensures the therapy is maintained at the prescribed level.
New clinical data supporting EVA’s efficacy will be presented at the American Society of Pain and Neuroscience 2025 Annual Conference in Miami, US.
The presentation will include 11 abstracts and one oral presentation, contributing to clinical evidence that includes over 37 publications and results from the landmark EVOKE Study.
Saluda Medical chief commercial officer Mike Mathias said: “This full commercial launch represents a significant advancement in SCS therapy and delivers on the promise of objective dosing and more effective pain relief for patients.
“In addition to its clinical benefits, EVA automates manual programming steps, thereby improving the patient experience.
“Since receiving FDA approval at the end of last year, EVA has been utilised in over 3,000 commercial patient visits through a limited market release.”
Saluda Medical specialises in developing treatments for chronic neurological conditions using its neuromodulation platform.
The company’s closed-loop, dose-control platform automatically adjusts therapy based on real-time neurophysiological feedback.
Earlier this year, Saluda Medical secured $100m in a financing round to advance the commercialisation of its Evoke System.
The Evoke System, the company’s first product, is designed to manage chronic intractable pain and optimise therapy through spinal cord stimulation.
Evolve Restorative Center founder and CEO Jason Pope said: “The Evoke SmartLoop System with EVA provides objective dosing that enables more predictable and durable outcomes in SCS.
“The data premiering at ASPN 2025 further demonstrates the compelling clinical benefits of the Evoke SmartLoop System, including increasing the diagnostic value of the trial phase and maintaining therapy response over time without loss of efficacy.”
