CLINICAL SUPERIORITY WITH THE EVOKE® SYSTEM
Innovation backed by proven experience and evidence
Using ECAP insights to build future innovation
Only the Evoke® System is backed by the most rigorous double-blinded pivotal RCT in the history of SCS
Billion personalized ECAP insights annually per patient
Years of experience
Investigator-initiated studies
The pioneering, landmark EVOKE study
First and Only Double-Blind, FDA Approval Study in SCS
- Prospective, multicenter, randomized, double-blind clinical trial of Evoke® Closed-Loop vs. Open-Loop SCS
- Patients and site staff were blinded through 36 months
The Longest Follow-Up Evidence from a Randomized Clinical Study In Spinal Cord Stimulation with 36-Month Data
Published in 2 premier medical journals. 36-month highlights1
Highest Reported Outcomes From the Only Double-Blinded SCS RCT At 36 Months1
Pain Responders
83%
of patients had
≥50% VAS Reduction
Pain High Responders
59%
of patients had
≥80% VAS Reduction
For Intent to Treat Patients: 78% responder rate and 49% high responder rate; Intention-To-Treat Patient analysis is a technique used in randomized controlled trials (RCTs) and is a conservative analysis where patient results are compared to each other within the groups in which they were initially randomized
- Mekhail NA et al. ECAP-Controlled closed-loop vs open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesthesia Pain Med 2023;0:1-9.
Enduring and Sustained Holistic Outcomes out to 36 months1
Improvement in multimodal outcome domains beyond pain
83%
Pain Relief
Responders: ≥50%
VAS Improvement
85%
Physical Function
ODI ≥10
68%
Mood
POMS TMD ≥10
68%
Sleep
PSQI ≥3
81%
Quality of life
EQ-5D ≥0.074
Zero
Explants
Due to loss of Efficacy
- Mekhail NA et al. ECAP-Controlled closed-loop vs open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesthesia Pain Med 2023;0:1-9.
When Allowed to Crossover at 24 Months, 9 out of 10 Patients Stayed in Closed-Loop Therapy*
Most Patients Exposed to Closed Loop Stayed in Closed-Loop1
Randomized
+
Blinded & Self-Selected Crossover At 24 Months
89%
68/76 Patients
Primary Reasons To Stay In Closed-Loop
Pain Relief
* Of those exposed to CL, 9/10 stayed in CL (5 crossed back into CL; 3 crossed from CL to OL)
The Evoke® System addresses the habituation and tolerance that has limited SCS therapy adoption through precise and consistent neural activation1
Cumulative Minimal Clinical Important Difference (MCID) Treatment Response*
* For patient-reported health outcomes, minimal clinical important difference (MCID) is an established approach to reflect changes after a clinical intervention that are meaningful for the patient.1 CUMULATIVE MCID RESPONSE is the SUM of Minimal Clinical Improvement (MCID) Improvements in ALL IMPAIRED BASELINE Outcome Domains including pain, quality of life, functional ability, mood and sleep quality/quantity; Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. Dec 1989;10(4):407-415.
- Mekhail NA et al. ECAP-Controlled closed-loop vs open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesthesia Pain Med 2023;0:1-9.
Precise and Consistent Neural Activation Resulted in Zero Explants Due to Loss of Efficacy
- Mekhail NA et al. ECAP-Controlled closed-loop vs open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesthesia Pain Med 2023;0:1-9.
Moving beyond pain relief to include holistic outcomes
Chronic pain is dynamic and multidimensional1
Published recommendations from a consortium including three professional societies—Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), Institute of Neuromodulation (IoN), and International Neuromodulation Society (INS)—suggest patient outcomes should be evaluated as a composite measure beyond just pain relief and include functional ability, sleep, quality of life, and mood for a more complete assessment of an individual’s response to spinal cord stimulation.
For the first time, defining holistic patient outcomes beyond pain relief
- PAIN RELIEF
- QUALITY OF LIFE
- MOOD
- FUNCTIONAL ABILITY
- SLEEP
Living a fuller life with Evoke® SmartSCS™
PAIN RELIEF
> 50% VAS
QUALITY OF LIFE
> 0.074 EQ-5D
Mood
> 10 POMS
FUNCTIONAL ABILITY
> 15 ODI
Sleep
> 3 PSQI
100%
90%
82%
67%
53%
Click on each measure to see the associated outcomes
Highest reported outcomes at 24 months3
The highest reported outcomes for pain relief, quality of life improvements, functional improvements, sleep quality, and mood at 24 months
VAS = Visual Analog Scale; ODI = Oswestry Disability Index; EQ-5D = EuroQol-5 Dimension; PSQI = Pittsburgh Sleep Quality Index; POMS = Profile of Mood States.
The Evoke® System: the highest reported RCT outcomes in pain and improvements in multidimensional patient outcomes in SCS Literature
The EVOKE study is the only 36-month SCS RCT with published holistic outcomes matching IMMPACT recommendations1
| Pain (VAS reduction) | Pain (Responder Rate) | Functional Improvement (ODI) | Quality of life (EQ-5D-5L/SF-12) | Opioid Reduction | Sleep improvement (PSQI) | Mood (POMS) | |
| EVOKE (Saluda) |  | | | | | | |
| Other Long-term RCTs in SCS (≥24-months) | |||||||
| SENZA4 (NVRO) | | | | – | NR | NR | – |
| PROCESS5 (MDT) | | | | | | – | – |
| PROMISE6 (MDT) | | | | | NR | NR | NR |
No published 24-month RCT from Abbott or Boston Scientific
“†Clinical trial data among different studies are not directly comparable and presented for educational and observational purposes only. Evoke® Smart SCS is deemed superior to Evoke® Open-Loop in treating overall back and leg pain. Clinical data and superiority claims are substantiated in the Summary of Safety and Effectiveness Data P190002.
“–” means not collected.
“NR” means not reported.
SCS = Spinal Cord Stimulation; RCT = Randomized Controlled Trial; VAS = Visual Analog Scale;
ODI = Oswestry Disability Index; EQ-5D-5L = EuroQol-5 Dimension 5-Level; SF-12 = 12-Item
Short Form Survey; PSQI = Pittsburgh Sleep Quality Index; POMS = Profile of Mood States.”
1. Kapural L, Yu C, Doust MW, et al. Comparison of 10-kHz high-frequency and traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: 24-month results from a multicenter, randomized, controlled pivotal trial. Neurosurgery. 2016;79(5):667-677.
2. Kumar K, Taylor RS, Jacques L, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4):762-770.
3. Rigoard P, Basu S, Desai M, et al. Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial. Pain. 2019;160(6):1410-1420.
The Evoke® System real-world evidence parallels the EVOKE RCT and the AVALON study clinical outcomes
Overall Pain Responders
EVOKE Study1 (36M)
AVALON Study7 (24M)
