Saluda Medical, a pioneer in the development and commercialization of a novel neuromodulation platform designed to transform the lives of patients with chronic neurological conditions, announced the full commercial launch of EVA, its next-generation sensing technology, in the United States (U.S.). EVA received U.S. Food & Drug Administration (FDA) approval in December 2024 and is compatible with all commercially implanted Evoke® SmartLoop™ System patients.
EVA, an extension of the Evoke System, objectively scans and analyzes a patient’s spinal cord to deliver personalized therapy with precision beyond human capability. The Evoke SmartLoop System optimizes patient outcomes by sensing, measuring, and adjusting stimulation based on each patient’s neural response biomarker, known as the evoked compound action potential (ECAP), to maintain therapy at the patient’s prescribed level.
“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,” said Mike Mathias, Chief Commercial Officer at Saluda Medical. “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 utilized in over 3,000 commercial patient visits through a limited market release.”
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New clinical data to be presented at the American Society of Pain and Neuroscience (ASPN) 2025 Annual Conference, to be held July 17 – 20, 2025 in Miami, FL, will feature 11 abstracts and one oral presentation, which add to Saluda Medical’s significant body of existing clinical evidence, including over 37 total publications. Among these are results from the landmark EVOKE Study, which demonstrated long-term efficacy out to 36-months.
“The Evoke SmartLoop System with EVA provides objective dosing that enables more predictable and durable outcomes in SCS,” said Jason Pope, MD, Founder and CEO, Evolve Restorative Center. “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.”
SOURCE: PRNewswire