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Innovation Backed by Evidence

Validated by the Most Robust Clinical Data1

Our data has evolved from capturing the first spinal cord ECAPs to superior long-term outcomes, then first of its kind objective dosing to maximise relief​.

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Publications

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Scientific presentations

PROVEN EVIDENCE

Proven in Practice

Backed by the landmark EVOKE Study—The only SCS therapy with double-blinded RCT evidence with 36-month outcomes.1

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of patients are pain responders (≥50% VAS reduction)

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of patients are high-pain responders (≥80% VAS reduction)

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of three month responders were still responders at three years

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of patients are satisfied to very satisfied with their experience

The Evoke® System

Clinical Superiority in SCS

​The highest reported RCT outcomes in pain and improvements in multidimensional patient outcomes in SCS Literature.2

Pain
(VAS reduction)		Pain
(Responder Rate)		Functional Improvement
(ODI)		Quality of life
(EQ-5D-5L/SF-12)		Opioid
Reduction		Sleep
improvement
(PSQI)		Mood
(POMS)
SALUDACheck mark 36-MonthCheck mark 36-MonthCheck mark 36-MonthCheck mark 36-MonthCheck mark 36-MonthCheck mark 36-MonthCheck mark 36-Month
Other Long-term RCTs in SCS (≥24-months)†
NEVRO324-months24-months24-months–Not ReportedNot Reported–
MEDTRONIC4,524-months24-months24-months24-monthsNot ReportedNot ReportedNot Reported
ABBOTT–––––––
BOSTON SCIENTIFIC–––––––

Long-Lasting Relief And Improved Quality Of Life2

Pain Relief

Nearly 83% experienced long-term pain relief

Quality Of Life

More than 81% experienced better quality of life

Mood

68% experienced better mood

Functional Ability

Nearly 85% had improved function to perform daily activities

Sleep

Patients gained on average more than 1 hour of additional sleep per night

Key Publications

Maximal Analgesic Effect Attained by the Use of Objective Neurophysiological Measurements With Closed-Loop Spinal Cord Stimulation

Levy et al., Max Analgesic Effect Attained by the Use of Objective Neural Metrics

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Mekhail et al., EVOKE Study 36 Month Closed-Loop Outcomes

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Mekhail et al., JAMA Neurology (24M)

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Mekhail et al., LANCET Neurology (12M)

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Kapural et al., Durable Multimodel and Holistic Response

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Duarte et al., Health
Economics

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Mekhail et al., EVOKE Study OL vs CL Therapy 36 Month

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Recent Publications

Goree et al., First Objective Evidence Characterizing Differences in Cervical and Thoracic Spinal Cord

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Hunter et al., ECAP-controlled closed-loop spinal cord stimulation for chronic non-surgical refractory back pain

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Nijhuis et al., European Real-World Data

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Pope et al., Trial Responders Immediately After Postoperative Programming

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Muller et al., Biomarker-Based Dose-Response Relationship

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Published Articles

Publication

Study

2025

2024

2023

2022

2021

2020

2018

2017

2013

2011

Publication

Study

2025

Goree, J.H., Nijhuis, H., Smith, G.L. et al. First Objective Evidence Characterizing Differences in Cervical and Thoracic Spinal Cord Neurophysiology Using ECAP-Controlled Closed-Loop Technology

N/A

2025

Hunter CW, Raskin JS, Mekhail NA, et al. ECAP-controlled closed-loop spinal cord stimulation for chronic non-surgical refractory back pain

EVOKE Clinical Study

2024

Robert M. Levy et al. Maximal Analgesic Effect Attained by the Use of Objective Neurophysiological Measurements With Closed-Loop Spinal Cord Stimulation

Avalon Clinical Study

2024

Pope J, Antony A, Petersen E, et al. Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy

Prospective, Real-World, Multicenter IDE Sub-Study

2024

Nijhuis H, Kallewaard JW et al. Durability of Evoked Compound Action Potential (ECAP)-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) in a Real-World European Chronic Pain Population. Manuscript submitted to Pain and Therapy Journal

EU Real-World (DR) Study

2024

Eldabe, S, Nevitt S, Bentley A, Mekhail NA, Gilligan C, Billet B. et al. Network Meta-analysis and Economic Evaluation of Neurostimulation Interventions for Chronic Non-surgical Refractory Back Pain. The Clinical Journal of Pain. 2024. DOI: 10.1097/AJP.0000000000001223.

EVOKE Clinical Study

2024

Mekhail NA, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, et al. Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain. Reg Anesth Pain Med. 2024;0:1-8. Doi: 10.1136/rapm-2024-105370.

EVOKE Clinical Study

2024

Muller L, Pope J, Verrils P, Petersen E, Kallewaard JW, Gould I, et al. First Evidence of a biomarker-based dose-response relationship in chronic pain using physiological closed-loop spinal cord stimulation. Reg Anesth Pain Med. 2024;0:1-7. Doi: 10.1136/rapm-2024-105346.

Clinical Studies +
Commercial Patients

2024

Su PY, Arle J, Poree L. Closing the loop and raising the bar: Automated control systems in neuromodulation. Pain Practice. 2024 Jan;24(1):177-85.

N/A

2024

Versantvoort E, Dietz BE, Mugan D, Vuong QC, Luli S, Obara I. Evoked compound action potential (ECAP)-controlled closed-loop spinal cord stimulation in an experimental model of neuropathic pain in rats. 2024;10(2):1-17. DOI: 10.1186/s42234-023-00134-1.

Non-sponsored, Investigator-Initiated Preclinical Study

2023

Duarte RV, Bentley A, Soliday N, Leitner A, Gulve A, Staats PS, et al. Cost-utility Analysis of Evoke Closed-Loop Spinal Cord Stimulation for Chronic Back and Leg Pain. The Clinical Journal of Pain. 2023; online ahead of print. 

EVOKE Clinical Study

2023

Leitner A, Hanson E, Soliday N, Staats P, Levy R, Pope J, et al.  Real World Clinical Utility of Neurophysiological Measurement Utilizing Closed-Loop Spinal Cord Stimulation in a Chronic Pain Population: The ECAP Study Protocol.  Journal of Pain Research. 2023; 16:2497-2507.

ECAP Clinical Study

2023

Levy R, et al. Holistic treatment response: an international expert panel definition and criteria for a new paradigm in the assessment of clinical outcomes of spinal cord stimulation. Neuromodulation 2023; 26(5): 1015-1022.

N/A

2023

Kapural L, Mekhail NA, Costandi S, Gilmore C, Pope JE, Li S, et al. Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial. Reg Anesth Pain Med. 2023.

EVOKE Clinical Study

2023

Mekhail N, Levy R, Deer T, Kapural L, Li S, Amirdelfan K, et al. ECAP-controlled Closed-Loop versus Open-Loop SCS for the Treatment of Chronic Pain: 36-month Results of the Evoke Blinded Randomized Clinical Trial. Reg Anesth Pain Med. 2023; 0:1-9.

EVOKE Clinical Study

2023

Nijhuis, HJA, Hofste WJ, Krabbenbos IP, Dietz BE, Mugan D, and Huygen F. First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. Pain Therapy. 2023; online ahead of print.

EU Real-World (DR) Study

2023

Poree L, Foster A, Staats P. Device Profile of the Evoke Physiologic Closed-Loop Spinal Cord Stimulation System for the Treatment of Chronic Intractable Pain: Overview of its Safety and Efficacy. Expert Review of Medical Devices. 2023; DOI: 10.1080/17434440.2023.2255520.

Avalon Clinical Study
 
EVOKE Clinical Study

2023

Single P, Scott JB, Life Senior Member, IEEE, Mugan D. Measures of Dosage for Spinal-Cord Electrical Stimulation: Review and Proposal. IEE Transaction on Neural Systems and Rehabilitation Engineering. 2023;31:4653-4660. DOI: 10.1109/TNSRE.2023.3335100.

N/A

2022

Costandi S, Kapural L, Mekhail N, Jotwani R, Bertisch S, Li S, et al. Impact of Long-Term Evoked Compound Action Potential Controlled Closed-Loop Spinal Cord Stimulation on Sleep Quality in Patients with Chronic Pain: An Evoke Randomized Controlled Trial Study Subanalysis. Neuromodulation Technol Neural Interface. 2022; 1-9.

EVOKE Clinical Study

2022

Dietz BE, Mugan D, Vuong QC, Obara I. Electrically Evoked Compound Action Potentials in Spinal Cord Stimulation: Implications for Preclinical Research Models. Neuromodulation Technol Neural Interface. 2022 Jan; 25(1): 64-74.

Non-sponsored, Investigator-Initiated Preclinical Study

2022

Falowski S, Kim C, Obradovic M, Parker J. A Prospective Multicenter Case Series Utilizing Intraoperative Neuromonitoring with Evoke Compound Action Potentials to Confirm Spinal Cord Stimulation Lead Placement. Neuromoducation. 2022;25(5):724-30.

EVOKE Clinical Study

2022

Mekhail N, Levy R, Deer T, Kapural L, Li S, Amirdelfan K, 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):251-260. doi:10.1001/jamaneurol.2021.4998.

EVOKE Clinical Study

2022

Taylor R, Soliday N, Leitner A, Hunter C, Staats P, Li S, et al. Association Between Levels of Functional Disability and Health-Related Quality of Life With Spinal Cord Stimulation for Chronic Pain. Neuromodulation Technol Neural Interface.  2022 May; S1094-7159(22)00650-X.

Avalon Clinical Study
 
EVOKE Clinical Study

2021

Brooker C, Russo M, Cousins MJ, Taylor N, Holford L, Martin R, et al. ECAP‐Controlled Closed‐Loop Spinal Cord Stimulation Efficacy and Opioid Reduction Over 24‐Months: Final Results of the Prospective, Multicenter, Open‐Label Avalon Study. Pain Pract. 2021 Jul;21(6):680–91. 

Avalon Clinical Study

2021

Deer TM, Hagedorn JM, Jameson JB, Mekhail N.  A New Horizon in Neuromodulation. Pain Medicine. 2021 Apr; 22(4):1012-1014.

EVOKE Clinical Study

2021

Duarte, RV, Soliday N, Leitner A, Taylor RS. Health-Related Quality of Life Associated with Pain Health States in Spinal Cord Stimulation for Chronic Neuropathic Pain. Neuromodulation Technol Neural Interface. 2021 Jan; 24(1):142-149.

Avalon Clinical Study
 
EVOKE Clinical Study

2021

Gmel GE, Santos Escapa R, Parker JL, Mugan D, Al-Kaisy A, Palmisani S. The Effect of Spinal Cord Stimulation Frequency on the Neural Response and Perceived Sensation in Patients With Chronic Pain. Front Neurosci. 2021 Jan 21;15:625835. 

Frequency Effects Basic Science Clinical Study

2020

Parker JL, Obradovic M, Hesam Shariati N, Gorman RB, Karantonis DM, Single PS, et al. Evoked Compound Action Potentials Reveal Spinal Cord Dorsal Column Neuroanatomy. Neuromodulation Technol Neural Interface. 2020 Jan; 23(1):82-95.

MCS Sheep Preclinical Study

2020

Mekhail N, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, et al. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020 Feb; 19(2): 123-134.

EVOKE Clinical Study

2020

Parker J, Karantonis D, Single P. Hypothesis for the Mechanism of Action of ECAP-controlled Closed-Loop Systems for Spinal Cord Stimulation. Healthcare Technology Letters. 2020 May 15;7(3):76-80. 

N/A

2020

Russo M, Brooker C, Cousins MJ, Taylor N, Boesel T, Sullivan R, et al. Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study. Neurosurgery. 2020 Sep; 87(4):E485-E495. 

Avalon Clinical Study

2018

Levy R, Deer TR, Poree L, Rosen SM, Kapural L, Amirdelfan K, et al. Multicenter, Randomized, Double-Blind Study Protocol Using Human Spinal Cord Recording Comparing Safety, Efficacy, and Neurophysiological Responses Between Patients Being Treated with Evoked Compound Action Potential-Controlled Closed-Loop Spinal Cord Stimulation or Open-Loop Spinal Cord Stimulation (the Evoke Study). Neuromodulation Technol Neural Interface. 2018 Dec; 22:317-326. 

EVOKE Clinical Study

2018

Parker JL, Laird-Wah J, Cousins MJ. Comparison of a simple model of dorsal column axons with the electrically evoked compound action potential. Bioelectron Med. 2018 May 1;1(2):117–30.

MCS Sheep Preclinical Study

2017

Russo, Marc, Michael J. Cousins, Charles Brooker, Nathan Taylor, Tillman Boesel, Richard Sullivan, Lawrence Poree, Nastaran hesam Shariati, Erin Hanson, and John Parker. “Effective Relief of Pain and Associated Symptoms with Closed-Loop Spinal Cord Stimulation System: Preliminary Results of the Avalon Study.” Neuromodulation: Technology at the Neural Interface. (Sep 2017) doi: 10.1111/ner.12684.

Avalon Clinical Study

2013

Parker, John L., Dean M. Karantonis, Peter S. Single, Milan Obradovic, James Laird, Robert B. Gorman, Leigh A Ladd, and Michael J. Cousins. “Electrically Evoked Compound Action Potentials Recorded from the Sheep Spinal Cord.” Neuromodulation: Technology at the Neural Interface 16, no. 4 (August 2013): 295–303. doi:10.1111/ner.12053.

MCS Sheep Preclinical Study

2011

Parker JL, Karantonis DM, Single PS, Obradovic M, and Cousins MJ. “Compound Action Potentials Recorded in the Human Spinal Cord during Neurostimulation for Pain Relief.” Pain 153, no. 3 (March 2012): 593–601. doi:10.1016/j.pain.2011.11.023. 

First Human Clinical Study

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