Australian device manufacturer Saluda Medical has reported favourable outcomes from two clinical studies of its Evoke ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) system in patients suffering from chronic pain.
The Evoke system is designed to measure the spinal cord’s response to stimulation via evoked compound action potentials (ECAPs), as well as adjust on every pulse to maintain activation within the patient’s therapeutic window.
Named Evoke and Avalon, the clinical studies showed improvements in pain, function, sleep, and quality of life when treated with the SCS device.
The double-blind, randomised, US regulatory approval Evoke study demonstrated better pain relief rates and secondary outcomes with closed-loop compared to control, noted Saluda Medical.
Avalon was an Australian prospective, single-arm study conducted to gather long-term evidence for sustained pain relief with closed-loop.
Evoke Study investigator Steven Falowski said: “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.”
At three months, the closed-loop SCS system led to statistically superior back and leg pain relief compared to control in the US Evoke study. Data revealed that more than 80% of participants on closed-loop achieved greater than or equal to 50% pain relief.
In addition, 58.1% of closed-loop subjects had greater than or equal to 80% decrease in back and leg pain.
During the Australian Avalon study, 69.4% of patients reported more than 80% pain relief at 18 months. Alongside this, 83.3% of subjects had a clinically meaningful improvement in the quality of life.
Furthermore, more than 72.2% of patients had minimal to moderate disability compared to 18% at baseline. Reduced or eliminated opioid medications were observed in 67.9% of participants.
Study data was presented at the International Neuromodulation Society (INS) 14th World Congress in Sydney, Australia.