Saluda Medical has announced plans for a limited commercial release of its Evoke spinal cord stimulation (SCS) system in the USA, with a full commercial release expected in 2023.
The Evoke system is the first and only US Food and Drug Administration (FDA)-approved therapy with 24-month follow-up evidence from a double-blind randomised clinical study in spinal cord stimulation, demonstrating enduring pain relief and marked improvements in holistic patient outcomes that extend beyond pain relief, including quality of life, functional ability, mood, and sleep, say Saluda Medical.
At 24 months, the EVOKE study showed zero explants due to loss of efficacy. The Centers for Medicare and Medicaid Services considered the Evoke system a “substantial clinical improvement” when it granted Evoke the Transitional Pass-Through Payment (TPT) effective 1 January 2023. Landmark 36-month evidence from the EVOKE study will be presented at the North American Neuromodulation Society (NANS) 26th annual meeting (12–15 January 2023; Las Vegas, USA).
Lawrence Poree, director of neuromodulation at University of California, San Francisco-School of Medicine (San Francisco, USA), said: “The Evoke system therapy stands to address the reported clinical efficacy challenges associated with existing fixed-output systems that have in the past limited broader adoption of SCS therapy.
“Through precise and consistent neural activation, the Evoke therapy is well-positioned to transform the SCS category by providing clinicians with objective and actionable neural insights where they previously relied on subjective patient feedback to titrate therapy.”
Timothy Deer (The Spine and Nerve Centre of the Virginias, Charleston, USA), added: “With current SCS modalities, we still do not completely understand the mechanism for pain relief with stimulation of the dorsal column or how the spinal cord responds to fixed-output stimulation. Thus, we are reliant on subjective, patient-reported outcomes to measure therapy efficacy.
“I believe the Evoke system’s ground-breaking, ECAP-controlled closed-loop therapy will create a new paradigm in spinal cord stimulation enabling customised, objective therapy for patients, clinicians, and payers. This is something that has never been seen before in neuromodulation.”
Jason Pope, of the Evolve Restorative Center (Santa Rosa, USA), commented: “I have seen a substantial difference between the Evoke system and other SCS systems in my patients. The closed-loop technology is novel and unique, demonstrating objective measurements of efficacy and consistent, long-term multidimensional improvements for my patients.
“The expected three-year follow-up data premiere from the EVOKE study in early 2023 will be the first of its kind in the history of neuromodulation. Patients, physicians, and payers will appreciate seeing the sustained long-term efficacy of this device as seen in the randomised controlled trial data.”