The pivotal EVOKE study randomly assigned patients with intractable pain of the back and legs 1:1 to ECAP-controlled, closed-loop SCS or fixed-output, open-loop SCS. Approved for the treatment of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain, it became the first and only available system to capable of instantaneously reading, recording, and responding to evoked compound action potentials (ECAPS), or the nerves that respond to stimulation, to provide more optimized performance. 1 "We can now see how much patients benefited from more consistent activation of the spinal cord, which is something we were previously unable to do with other SCS systems."Ī study that spanned across 13 US sites, EVOKE was the basis for the FDA’s decision to approve the SCS System in March 2022. "The Evoke® System is the only SCS therapy capable of continuously listening to the spinal cord and optimizing neural activation with precise, prescriptive closed-loop dosing based upon an individual patient's unique neural signature," Mekhail said in a statement. Additionally, 49% of this population achieved at least an 80% reduction as well. Presented by Nagy Mekhail, MD, PhD, professor of anesthesiology, Carl Wasmuth Chair, and director, Evidence-Based Pain Management Research, Cleveland Clinic, findings showed that 78% of the 134-patient intention-to-treat cohort who received the closed-loop arm system achieved at least 50% pain reduction.
Presented at the 2023 North American Neuromodulation Society (NANS) annual meeting, new 36-month data from the EVOKE clinical trial (NCT02924129) showed never-before-seen outcomes in treating back and leg pain using Saluda Medical’s Evoke SmartSCS spinal cord stimulation (SPS) system.