By measuring the spinal cord’s response to electrical stimulation—and incorporating that feedback by adjusting treatment within a closed loop—Saluda Medical showed its implant was able to provide long-term, meaningful relief to people with chronic back and leg pain.
In pivotal study results published in The Lancet Neurology, former Fierce 15 winner’s Evoke spinal cord device reduced or eliminated the use of opioid painkillers after one year among 55% of treated patients, compared to 40% of those who received open-loop stimulation.
Evoke gauges the body’s reaction to every electrical pulse and works to optimize its therapeutic delivery. About 83% of patients implanted with the closed-loop device reported that their pain was cut in half or more, compared to 61% in the control group.
“In fixed-output and open-loop SCS systems, the amount of energy reaching the spinal cord continually fluctuates, faster than a patient can adjust with a remote, resulting in less time within the therapeutic window,” said study first author Nagy Mekhail, a professor at the Cleveland Clinic Lerner College of Medicine.
Saluda’s closed-loop system stayed within the therapeutic window 95.2% of the time, compared to 47.9% with the open-loop device, according to the company.
“Beyond the clinical results, this study has important practical implications as it establishes that individual-specific therapeutic windows can be identified and targeted to maintain spinal cord activation at therapeutic levels and improve care long term,” said Mekhail, who is also director of Evidence-Based Pain Medicine Research and Education at the Cleveland Clinic.
The Australian company received a CE mark and began its European commercial rollout last September, with its first implant procedures being conducted in the Netherlands.
“We are now reaching a major junction, similar to that of the evolution of the cardiac pacemaker, where for the first time, we can record and respond to patient’s individual spinal cord electrophysiology continuously and in real time, providing adjustments millions of times per day and faster than any patient can adjust or predict,” said Saluda CEO John Parker.