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FDA Approves Evoke Spinal Cord Stimulation System for Chronic Intractable Pain
The US Food & Drug Administration recently approved the Evoke® Spinal Cord Stimulation (SCS) System 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, maker Saluda Medical announced.
Evoke is the only SCS system that instantaneously reads and responds to evoked compound action potentials, a measure of the nerves’ response to stimulation, to continually adjust therapy and maintain optimal pain inhibition, the company explained. Additionally, Evoke records millions of data points daily to provide clinicians with neurophysiological insight into therapy performance.
“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,” 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.
The EVOKE study is the first double-blind, randomized controlled trial to support the premarket approval of an SCS system, according to the company. The study randomized 134 patients 1:1 to Evoke closed-loop SCS or open-loop SCS. Compared with open-loop SCS, closed-loop SCS demonstrated superior pain relief with no increase in pain medication at 12 months. Clinically meaningful improvement at 12 months was reported by 78.2% of closed-loop SCS patients on the Oswestry Disability Index, by 70.9% on the Profile of Mood States, by 76.4% on the Pittsburgh Sleep Quality Index, and by 85.5% on the European Quality of Life survey. Furthermore, Evoke closed-loop SCS maintained spinal cord activation within the therapeutic window 95.2% of the time.
Related: FDA Approves Neurostimulation System for Chronic Low Back Pain
Clinical outcomes were durable at 24 months, with no explants due to loss of efficacy, the company reported.
“For the last 50 years, our field has relied on subjective feedback from the patient to optimize therapy with results in published literature demonstrating good clinical outcomes, but also highlighting challenges with predictable long-term durability,” said Timothy R. Deer, MD, president and CEO of the Spine and Nerve Center of The Virginias and clinical investigator. “I've seen firsthand the clinical benefits of tightly controlling stimulation by measuring the body’s neurophysiological response and how this pioneering closed-loop technology is redefining the SCS experience for patients and clinicians.”
Saluda Medical is planning a limited release of the Evoke system in the second half of 2022. A full commercial release will follow in 2023.
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