Saluda Medical has announced the full US commercial launch of its EVA sensing technology, which is intended for scanning and analysing the spinal cord of individuals to offer personalised therapy.
In December 2024, the Food and Drug Administration (FDA) approved EVA, which is now compatible with all patients implanted with the Evoke SmartLoop System.
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EVA represents an extension of the Evoke System, which is Saluda Medical’s inaugural product, indicated for managing chronic intractable pain. This includes unilateral or bilateral pain related to failed back surgery syndrome and intractable low back and leg pain.
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.”
The company noted that the Evoke SmartLoop System is known for optimising the outcomes of individuals by sensing, measuring, and adjusting stimulation based on the neural response biomarker of the patient, ensuring therapy is maintained at the prescribed level.
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By GlobalDataThe presentation of new clinical data on EVA will take place at the ASPN 2025 Annual Conference on 17-20 July 2025 in Florida, US.
This conference will feature 11 abstracts and an oral presentation, contributing to the company’s clinical evidence, which includes more than 37 publications.
The landmark EVOKE Study, which will be among the data presented, has shown long-term efficacy of up to 36 months.
Saluda Medical develops treatments for chronic neurological conditions through its neuromodulation platform.
Earlier this year, the company completed a financing round of $100m to further commercialise the Evoke System.
