Friday, December 16, 2022
Saluda Medical Pty Limited, a global medical device company revolutionizing the field of neuromodulation, today announced it has initiated the commercialization of the Evoke® System, the first and only SmartSCS™ in the United States. The U.S. launch of the Evoke System will be a limited commercial release (LCR) designed to expand patient access to this disruptive technology, prioritizing patient outcomes and providing advanced insights into this new electroceutical therapy. The Company plans to initiate a full commercial release (FCR) of the Evoke System in 2023, enabling access to more patients, clinics, and hospitals in the U.S.
The Evoke System is the first and only FDA-approved therapy with 24-month follow-up evidence from a double-blind randomized clinical study in SCS, 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. At 24 months, the EVOKE Study showed zero explants due to loss of efficacy. The Centers for Medicare and Medicaid Services (CMS) considered the Evoke System a "substantial clinical improvement" when it granted Evoke the Transitional Pass-Through Payment (TPT) effective January 1, 2023. Landmark 36-month evidence from the EVOKE Study will be presented in January at NANS 2023.
The initiation of the Evoke LCR follows over ten years of advanced research and development in the utilization of ECAP insights and more than twenty studies to date demonstrating consistent long-term patient outcomes. The LCR will involve implanters from the pivotal PMA EVOKE Study and the ECAP Study.
"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," said Dr. Lawrence Poree, MD, PhD, Director of Neuromodulation at University of California, San Francisco-School of Medicine.
"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," said Timothy Deer, MD, Chairman, American Society of Pain and Neuroscience, President and CEO, The Spine and Nerve Center of the Virginias, Clinical Professor of Anesthesiology and Pain Medicine, WVU School of Medicine. "I believe the Evoke System's ground-breaking, ECAP-controlled closed-loop therapy will create a new paradigm in spinal cord stimulation enabling customized, objective therapy for patients, clinicians, and payors. This is something that has never been seen before in neuromodulation."
"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," said Jason Pope, MD, DABPM, FIPP, Evolve Restorative Center. "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 payors will appreciate seeing the sustained long-term efficacy of this device as seen in the RCT data."