Evoked Compound Action Potentials enable closed-loop SCS superiority over open-loop in multicenter RCT — Saluda Medical Evoke
Summary
A multicenter randomized controlled trial of Saluda Medical's Evoke System — the first SCS system using Evoked Compound Action Potentials (ECAPs) to directly measure the spinal cord's response to stimulation and automatically optimize therapy — demonstrated statistical superiority over conventional open-loop SCS for trunk and/or limb pain relief. The system measures ECAPs 4+ million times per day, continuously adapting to posture changes and physiological variation that cause conventional SCS to under- or over-stimulate. The superiority finding establishes Evoke as the evidence-based preferred approach for SCS programming.
Why it matters
Demonstrated RCT superiority over conventional SCS — not just equivalence — is the strongest possible evidence position for a medical device. Saluda's Evoke system achieving this changes the clinical and commercial calculus: clinicians who choose conventional SCS over Evoke in the absence of a compelling reason are potentially choosing an inferior therapy for their patients.
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