EVOKE Presentation Awarded Overall Winner at ASIPP Annual Meeting

/in

Received Outstanding Achievement in Research for EVOKE Clinical Trial

Sustained Superiority of Evoke® Closed-Loop Pain Relief and Improvement in Quality-of-Life Scores at 36-months

Artarmon, Australia – March 22, 2023 – Link here – Saluda Medical Pty Limited (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation, today announced that the EVOKE 36-month Study received the Outstanding Achievement in Research Award at the 25th annual meeting of the American Society of Interventional Pain Physicians (ASIPP) in National Harbor, MD. The plenary session presentation titled “ECAP-Based Spinal Cord Stimulation (SCS) for the Treatment of Chronic Pain: EVOKE Study 36-Month Outcomes” was presented by Dr. Sean Li, MD, Interventional Pain Physician and Clinical Researcher at Premier Pain Centers, Shrewsbury, NJ on behalf of the clinical study investigators.

The 36-month evidence from the EVOKE Study demonstrates the most enduring patient outcomes from a pivotal, randomized clinical study in the history of SCS. The double-blind, RCT study included 134 randomized patients across 13 U.S. sites.

In addition to experiencing significant and durable pain relief, patients in the closed-loop arm experienced improvements in multiple dimensions of patient reported outcomes including pain relief, quality of life, functional ability, mood, and sleep at 36 months. Nine out of ten patients who experienced the Evoke(R) closed-loop therapy at any point in the study, chose to remain in closed-loop therapy through the duration of the study. “The EVOKE Study is a major milestone in the evolution of spinal cord stimulation. For the first time, with the Evoke System, pain physicians can optimally and precisely dose spinal cord stimulation with ECAP-controlled closed-loop therapy similar to medication dosing based on an individual patients’ needs”, said Dr. Sean Li. “Objective measurements and consistent neural activation enable the profoundly high levels of pain relief and zero explants due to loss of efficacy sustained out to three years.”

About Saluda Medical

 

Saluda Medical is a global company transforming patients’ lives with disruptive neural sensing technologies designed to revolutionize the field of neuromodulation. The company’s first product, the Evoke® System, is the only smart 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 each patient’s neural signature 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 in JAMA Neurology. Both publications 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 an elimination of explants due to loss of efficacy out to 24-months – which are significant challenges with current SCS therapies. To learn more, including risks & important safety information, visit www.saludamedical.com/us/safety/.

 

Saluda Medical and Evoke are registered trademarks owned by Saluda Medical Pty Ltd.