Saluda Medical Clinical Study Results for Evoke ECAP-Controlled, Closed-Loop SCS System for the Treatment of Chronic Pain

Saluda Medical Clinical Study Results

Australia-based Saluda Medical Pty Limited (Saluda Medical) reports data from two clinical studies evaluating the performance of the company’s Evoke® ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) System and its impact on pain relief for patients suffering from chronic pain. Evoke is designed to be the first closed-loop SCS system that measures the spinal cord’s response to stimulation (via ECAPs, or evoked compound action potentials) and adjusts on every pulse to maintain activation within the patient’s therapeutic window.

The Study

The Evoke and Avalon studies both demonstrated improvements in pain, function, sleep, and quality of life. These data substantiate the observation that considerable plain relief can impact a patient’s entire life, including reduction in pain medications.

Key results presented at the congress from the Evoke U.S. Pivotal Study at 3 months include:

  • Closed-loop met all pre-specified endpoints.
  • Closed-loop demonstrated statistically superior back and leg pain relief (with no increase in pain medications) compared to control with more than 80% (82.3% ) of closed-loop subjects achieving greater than or equal to 50% pain relief (control: 60.3% ).
  • More than half of closed-loop subjects (58.1% ) were high responders with greater than or equal to 80% reduction in back and leg pain (control: 42.9% ).
  • Closed-loop maintained spinal cord activation within the therapeutic window 1.5x that of the control group (91.1% of the time with closed-loop vs. 59.5% of the time with control).

Key results presented at the congress from the Avalon Australian Study at 18 months include:

  • More than 2 out of 3 patients (69.4% ) experienced more than 80% pain relief.
  • More than 8 out of 10 patients (83.3% ) experienced clinically meaningful improvement in quality of life.
  • Disability was also reduced, with more than 7 out of 10 patients (72.2% ) having only minimal to moderate disability compared to 18.0% at baseline.
  • More than 2 out of 3 patients (67.9% ) reduced or eliminated opioid medications.
  • Spinal cord activation was maintained within the therapeutic window 97.5% of the time.

Saluda Medical

Saluda Medical based in Australia, is dedicated to improving the lives of people by providing personalized responsive and efficient neuromodulation therapy. Formed in 2013, they have already raised $49 million.

Research Investigators

Steven M. Falowski, M.D., Director of Functional Neurosurgery at Neurosurgical Associates of Lancaster in Lancaster, PA and an investigator in the Evoke Study, said, “Two separate studies of the Evoke System show promising results. The U.S. Evoke study, the first double-blind randomized regulatory approval study in SCS, demonstrated better rates in pain relief and secondary outcomes for closed-loop compared to control. The Avalon study, an Australian prospective, single-arm study, provides long-term evidence for sustained pain relief with closed-loop. Both studies provide evidence supporting the novel design of the device where ECAPs are measured to monitor therapy delivery in real time. The technology provides an objective measure based on a neurophysiological response to control therapy delivery and provides insight into the mechanism of action. There were a plethora of talks featuring ECAPs at this congress and they highlight the potential clinical utility of this new technology.”

Dr. Charles Brooker, Director of the Pain Management and Research Centre, Royal North Shore Hospital and Principal Investigator in the Avalon Study, highlighted, “With Evoke, study results suggest that pain relief continues to improve over time.”