Saluda Medical, a global medical device business that is changing the field of neuromodulation, has begun commercialization of the Evoke® System, the first and only SmartSCSTM in the United States.
The U.S. debut of the Evoke System will be a limited commercial release (LCR) intended to increase patient access to this breakthrough technology, with a focus on patient outcomes and enhanced insights into this new electroceutical therapy.
The Company intends to launch a full commercial release (FCR) of the Evoke System in 2023, allowing more patients, clinics, and hospitals in the United States to have access to the product.
As per CISION PR Newswire, the Evoke System is the first and only FDA-approved therapy with 24-month follow-up evidence from a randomized, double-blind clinical study in SCS, demonstrating durable pain relief and marked improvements in holistic patient outcomes that extend beyond pain relief, including quality of life, functional ability, mood, and sleep.
At 24 months, there were no explants in the EVOKE study due to effectiveness loss. The Centers for Medicare & Medicaid Services (CMS) deemed the Evoke System to be a “significant therapeutic improvement” when it granted Evoke the Transitional Pass-Through Payment (TPT) beginning on January 1, 2023. The EVOKE Study’s landmark 36-month findings will be presented in January at NANS 2023.
The initiation of the Evoke LCR is the result of more than 10 years of advanced research and development in the application of ECAP insights, as well as more than twenty studies confirming consistent long-term patient outcomes. Implantologists from the key PMA EVOKE Study and the ECAP Study will participate in the LCR.
The Director of Neuromodulation at the University of California, San Francisco-School of Medicine, Dr. Lawrence Poree, MD, Ph.D., stated, “The Evoke System therapy has the potential to solve the acknowledged clinical efficacy issues associated with conventional fixed-output systems, which have historically hampered the widespread adoption of SCS therapy.
Through precise and consistent neural activation, the Evoke therapy is well-positioned to revolutionize the SCS category by providing clinicians with objective and actionable neural insights, whereas previously subjective patient feedback was used to titrate therapy.”
Dr. Timothy Deer, Chairman of the American Society of Pain and Neuroscience, President and CEO of The Spine and Nerve Center of the Virginias, and Clinical Professor of Anesthesiology and Pain Medicine at the West Virginia University School of Medicine stated the following:
“We do not fully comprehend the mechanism for pain alleviation with stimulation of the dorsal column or how the spinal cord responds to fixed-output stimulation with existing SCS modalities.
Thus, we rely on subjective patient-reported outcomes to evaluate the efficacy of a therapy”. “I believe that the Evoke System’s innovative ECAP-controlled closed-loop therapy will create a new paradigm in spinal cord stimulation, allowing for individualized, objective therapy for patients, physicians, and payers. This is something that neuromodulation has never seen before.”
“In my patients, I have observed a significant distinction between the Evoke System and other SCS systems. The closed-loop technology is innovative and one-of-a-kind, demonstrating objective measurements of efficacy and consistent, long-term benefits in multiple dimensions for my patients,” Evolve Restorative Center’s Jason Pope, MD, DABPM, FIPP, said.
“The anticipated release of three-year follow-up data from the EVOKE Study in early 2023 will be unprecedented in the history of neuromodulation. Patients, physicians, and payors will value the RCT evidence demonstrating the device’s maintained long-term efficacy.”