Saluda Medical has announced that late-breaking data from the “landmark” EVOKE clinical trial was presented at the recent North American Neuromodulation Society (NANS) annual meeting (12–15 January 2023, Las Vegas, USA). The data presented constitute “the longest follow-up evidence from a US investigational device exemption (IDE) trial in spinal cord stimulation (SCS) history”, the company claims.
The intention-to-treat (ITT) and crossover analysis of the 134 randomised patients across 13 US sites in this 36-month, double-blind, randomised controlled trial (RCT) was presented by Nagy Mekhail (Cleveland Clinic, Cleveland, USA) during the late-breaking clinical abstracts session.
The long-term data set demonstrated patients in the treatment arm receiving closed-loop Evoke SmartSCS system therapy experienced clinical outcomes “never before reported in SCS”—according to Saluda—including:
- Sustained superiority over open-loop in treating overall back and leg pain
- 78% of ITT (83% of implanted closed-loop patients) achieved >50% pain reduction
- 49% of ITT (59% of implanted closed-loop patients) achieved >80% pain reduction
- Zero explants due to loss of efficacy after 36 months of closed-loop therapy
- High patient satisfaction: 90% very satisfied or satisfied
While blinded to whether they were receiving closed-loop or open-loop therapy, patients were able to cross over to the other treatment arm at 24 months and then decide which arm they preferred. The majority of patients who crossed over from open-loop to closed-loop therapy chose to cross over in search of better pain relief. Saluda also states in a press release that, importantly, nine out of 10 patients treated with closed-loop at any time completed the study in the closed-loop arm.
In addition to experiencing significant and durable pain relief, blinded patients who crossed over to closed-loop experienced improvements in multiple dimensions of patient outcomes including quality of life, functional ability, mood and sleep at 36 months, achieving a similar level of treatment benefit as the blinded patients who had stayed in closed-loop therapy the entire 36 months.
“The Evoke system is the only SCS therapy capable of continuously listening to the spinal cord and optimising neural activation with precise, prescriptive closed-loop dosing based upon an individual patient’s unique neural signature,” said Mekhail. “We can now see how much patients benefitted from more consistent activation of the spinal cord, which is something we were previously unable to do with other SCS systems. Equally compelling is the Evoke system’s ability to deliver a more enduring solution to pain, highlighted by zero explants due to loss of efficacy through 36 months—something we have not seen before. This is one of the most important innovations in the field of neuromodulation since Norman Shealy implanted the first stimulator lead in 1967.”
“We sincerely thank our clinical investigators and patients who have partnered with us to pioneer the science and evidence for this new enduring treatment for chronic pain,” said Jim Schuermann, president and CEO of Saluda. “This unprecedented dataset strongly validates the recent recognition by CMS [Centers for Medicare and Medicaid Services] that the Evoke system represents a substantial clinical improvement over current standard of care, and we believe there is significant interest in this innovative new treatment option for patients seeking long-term pain relief.”