Saluda Medical has announced the full commercial launch of EVA, its next-generation sensing technology for spinal cord stimulation therapy, in the United States. The technology received FDA approval in December 2024 and is compatible with all commercially implanted Evoke SmartLoop System patients.
EVA represents an extension of the Evoke System, Saluda Medical's inaugural product indicated for managing chronic intractable pain of the trunk and limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. The technology objectively scans and analyzes a patient's spinal cord to deliver personalized therapy with precision beyond human capability.
Clinical Implementation and Patient Impact
The Evoke SmartLoop System with EVA 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. Since receiving FDA approval, EVA has been utilized in over 3,000 commercial patient visits through a limited market release.
"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."
Clinical Evidence and Research Presentation
New clinical data on EVA will be presented at the American Society of Pain and Neuroscience (ASPN) 2025 Annual Conference, held July 17-20, 2025 in Miami, Florida. The conference will feature 11 abstracts and one oral presentation, adding to Saluda Medical's significant body of existing clinical evidence, which includes over 37 total publications.
Among the data to be presented are results from the landmark EVOKE Study, which demonstrated long-term efficacy out to 36 months. The EVOKE study represents the first and only prospective, multi-center, parallel-arm, double-blind, randomized controlled pivotal study with a voluntary crossover arm in spinal cord stimulation that demonstrated clinically superior pain relief to open-loop therapy.
"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 of 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."
Technology Platform and Company Background
Saluda Medical is a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel neuromodulation platform. The company's closed-loop, dose-control platform senses and measures neural responses to stimulation and automatically adjusts therapy based on real-time neurophysiological feedback.
The clinical evidence supporting the Evoke System includes 12-month results published in The Lancet Neurology, 24-month results published in JAMA Neurology, and 36-month data demonstrating sustained pain relief published in Regional Anesthesia and Pain Medicine. Earlier this year, the company completed a $100 million financing round to further commercialize the Evoke System.
