Saluda Medical today released data from two studies of its Evoke ECAP-controlled closed-loop spinal cord stimulator.
The Evoke SCS system is designed to measure the spinal cord’s response to stimulation and adjust on every pulse to maintain activation within the patient’s therapeutic window, the Australian company said.
Results from both the Evoke and Avalon studies of the device were presented at the International Neuromodulation Society’s 14th World Congress in Sydney, Saluda Medical said.
Three-month results from the Evoke U.S. pivotal study indicated that the trial met all pre-specified endpoints and that the closed-loop system demonstrated superior back and pain relief when compared to the control in 82.3% of closed-loop subjects who achieved greater than or equal to 50% pain relief.
Data also indicated that 58.1% of closed-loop subjects were high responders with greater than or equal to 80% reduction in back and leg pain. Patients in the closed-loop group also maintained spinal cord activation within the therapeutic window at 1.5 times greater rates than the control group, Saluda 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,” Evoke study investgiator Dr. Steven Falowski of Pennsylvania’s Neurosurgical Associates of Lancaster said in a press release.
Results at 18 months from the Avalon Australian study showed that 69.4% of patients experienced more than 80% pain relief, while 83.3% experienced clinically meaningful improvements in quality of life. Disability rates were also reduced, with 72.2% of patients reporting only minimal to moderate disability as compared to 18% at baseline.
Data from the Avalon study also indicated that 67.9% of patients reduced or eliminated opioid medications and that spinal cord activation was maintained within a therapeutic window 97.5% of the time.
“With Evoke, study results suggest that pain relief continues to improve over time, which is not typically observed with fixed-output systems. With the capability of neurophysiology measurements, such as percentage time in the therapeutic window, we can now start to understand a complex condition objectively in addition to patient reported outcomes, an important advancement to the field of pain management,” Avalon study investigator Dr. Charles Brooker of the Royal North Shore Hospital said in a prepared release.
In March 2017, Saluda Medical said that it raised nearly $40 million (A$53 million) for its Evoke device.
