Saluda Medical Pty Limited (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders, today announced it received full approval from the United States Food and Drug Administration (FDA) for the Evoke® Spinal Cord Stimulation (SCS) System. The Evoke System is indicated 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.
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The Evoke System is the first and only available SCS system capable of instantaneously reading, recording, and responding to evoked compound action potentials (ECAPs) – the nerves’ response to stimulation – to provide precise, continually optimized therapy. Unlike commercially available SCS devices, the Evoke System was designed to maintain optimal pain inhibition by adjusting therapy more than 100 times per second1. The Evoke System also captures and records millions of data points per day to provide clinical teams with unparalleled neurophysiological insights in context of therapy performance.
“The groundbreaking technology behind the Evoke System’s ability to intelligently measure spinal cord activation has had many of us excited for a long time,” said Nagy Mekhail, MD, PhD, Professor at the Cleveland Clinic Lerner College of Medicine, Director of Evidence-Based Pain Medicine Research and Education in the Department of Pain Management at the Cleveland Clinic, and lead author and medical monitor for the EVOKE Study. “More exciting than the technology, though, is the unparalleled quality of the evidence backing this system which demonstrates pain relief coupled with clinically significant improvements in physical and emotional functioning, sleep quality, and health-related quality of life. This evidence gives me confidence that Evoke is well-suited to address the unmet need of providing long-term, durable pain relief with this therapy. Simply put, this is one of the most important innovations in the field of Neuromodulation since Dr. Norman Shealy developed the first spinal cord stimulation device in 1967.”
This is the first Premarket Approval (PMA) based on a double-blind randomized controlled trial (RCT), the EVOKE Study, for an SCS system. This Study substantiated the Evoke System’s† superiority designation compared to open-loop SCS in treating overall back and leg pain. In the closed-loop arm of the EVOKE Study, greater improvements in clinical outcomes coincided with more consistent spinal cord activation within subjects’ therapeutic window