ARTARMON, Australia, March 8, 2022 /PRNewswire/ -- 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.
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.
The EVOKE double-blind RCT data demonstrated the following benefits:
Superior Pain Relief
- Evoke† demonstrated superior pain relief compared to open-loop SCS at 12 months with no increase in pain medication (p-value = 0.006).
- Nearly 90% (or 9/10) of subjects implanted with Evoke† met the primary endpoint at 12-months, which was statistically superior to open-loop SCS (p = 0.039).
Clinically Meaningful Patient Reported Quality of Life Outcomes
- Percentage of Evoke† patients that demonstrated clinically meaningful improvements at 12 months2
- Disability (Oswestry Disability Index [ODI]), 78.2%
- Mood (Profile of Mood States [POMS]), 70.9%
- Sleep (Pittsburgh Sleep Quality Index [PSQI]), 76.4%
- Health-related quality of life (European Quality of Life [EQ-5D]), 85.5%
- Evoke† maintained spinal cord activation within the therapeutic window 95.2% of the time (vs. 47.9% with open loop).
EVOKE Study 24-month data recently published in JAMA Neurology showed that the clinical outcomes were durable at 24-months with zero explants due to loss of efficacy3. Reprogramming was practically eliminated between 12- and 24-months3,4.
"The FDA approval of the Evoke System marks a seminal moment in the field of spinal cord stimulation," said Timothy R. Deer, MD, President and CEO of the Spine and Nerve Center of The Virginias and clinical investigator. "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. 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."
"FDA approval for the Evoke System is a significant milestone for Saluda – one resulting from over a decade of advanced research and development and years of patient-centric determination to transform the standard of care. Evoke's innovations are born from John Parker's vision and pioneering research, and Saluda's strong and lasting partnerships with the clinical community and mutual dedication to patients," said Jim Schuermann, President and CEO. "I'd like to personally thank our employees and their families, our clinical investigators and, most importantly, the patients for the unwavering support throughout the process. This is an exciting step in our mission to revolutionize the field of neuromodulation."
The Company plans to implement a controlled, limited release of the Evoke System in the second half of 2022 among select trial sites before initiating a full commercial release in 2023.
To learn more about the Evoke System and to stay "in the loop" on future updates, visit www.jointheSCSrevolution.com.
About the U.S. EVOKE Pivotal Study
The U.S. EVOKE Study is the first double-blind RCT used in support of a PMA in the field of spinal cord stimulation. The trial was conducted at 13 sites throughout the U.S. and followed a total of 134 patients. Patients were randomized 1:1 to ECAP-controlled, closed-loop SCS or open-loop SCS. The same neuromodulation system (Evoke System) served as the investigational and control device, as it offered both ECAP-controlled closed-loop SCS and open-loop SCS. For both treatment groups, real-time spinal cord activation was determined from measured ECAPs and stored.
About Saluda Medical
Saluda Medical is a global company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders. The company's first product, the Evoke® System, is the only ECAP-controlled closed-loop spinal cord stimulation (SCS) system and is indicated as an aid in the management 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. The Evoke System instantaneously reads, records, and responds to the nerves' response to stimulation to provide continually optimized therapy and is proven to be superior to open-loop SCS for the treatment of overall trunk and/or limb pain. 12-month results from the EVOKE Study, the first double-blind randomized controlled trial (RCT) used in support of Premarket Approval (PMA) in spinal cord stimulation history, were published in The Lancet Neurology and 24-month results have since been published JAMA Neurology. Both studies are poised to set new clinical standards for long-term pain relief and improvements in physical and emotional functioning, sleep quality and health-related quality of life. Furthermore, there is promising data to show the Evoke System demonstrated a reduction in re-programming visits over time as well as eliminated the occurrence of explants due to loss of efficacy – which are significant challenges with current SCS therapies. To learn more, including the risks & important safety information, visit www.saludamedical.com.
Saluda and Evoke are registered trademarks owned by Saluda Medical Pty Ltd.
Clinical data and superiority claims are substantiated in the Summary of Safety and Effectiveness Data P190002.
† Indicates Evoke closed-loop spinal cord stimulation.
1. Stimulation adjustments are made at the same rate of frequency; mean frequency for EVOKE Study patients at 12-months was 37.7 Hz for closed-loop and 38.8 Hz for open-loop. Mekhail N, Levy RM, Deer TR, et al. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomized, controlled trial. Lancet Neurol. 2020;19(2):123-134.
2. Secondary endpoints were not prespecified and were not adjusted for multiplicity.
3. Mekhail N, Levy RM, Deer TR, et al. Durability of Clinical and Quality-of-Life Outcomes of Closed-Loop Spinal Cord Stimulation for Chronic Back and Leg Pain; A Secondary Analysis of the Evoke Randomized Clinical Trial. JAMA Neurol. 2022;79(3):1-10.
4. Median (IQR) number of visits per patient per month between 12- and 24-months follow-up was 0.0 (0.0-0.1).
SOURCE Saluda Medical