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

ABSTRACT

Introduction

The Evoke® spinal cord stimulation (SCS) device enables the closed-loop feedback of dynamically measured evoked compound action potentials (ECAPs) to adjust stimulation amplitude for every stimulation pulse to maintain the stimulation output level near a targeted ECAP amplitude. No other commercially available SCS device presently uses physiologic feedback from the spinal cord to adjust stimulation. Clinicians should be familiar with the differences in devices and with the latest technologies to provide optimized patient care.

Areas covered

In this device profile, the Evoke system is described and the system capabilities are differentiated from other available SCS devices. A systematic review was conducted based on best practice guidance to identify all available evidence on the safety and efficacy of the Evoke SCS system.

Expert opinion

The Evoke SCS system offers unique capabilities as a means to optimize therapy delivery tailored to each individual patient. Data through 24-months follow-up show statistically significant, clinically meaningful, ample, consistent, and strong evidence of the safety and efficacy of the Evoke system for the treatment of chronic intractable pain.

KEYWORDS:

• Chronic pain
• closed-loop SCS
• evoked compound action potentials
• neurophysiological measurement
• spinal cord stimulation

Article highlights

• The Evoke System is the only commercially available SCS system that confirms activation of the intended neural target via the neurophysiological measurement of the ECAP.

• The Evoke System may deliver 1) open-loop stimulation, equivalent to the mechanism used by other commercially available SCS systems but with the additional feature to measure ECAPs; or 2) ECAP-controlled closed-loop stimulation, where the stimulation amplitude is automatically adjusted in real-time (on every pulse, i.e. rate responsive) to minimize the difference between the measured ECAP and the target ECAP to deliver consistent spinal cord activation at the target level.

• The clinical efficacy and safety data that underpins the use of Evoke ECAP-controlled closed-loop SCS is the most robust in SCS literature to date and supports the effectiveness, safety and cost-effectiveness profile of the Evoke system. The Evoke System has a profound SAFE profile in appropriately selected patients based on published evidence and patient adherence.

Acknowledgments

The authors are grateful to Rui Duarte, Nicole Soliday and Angela Leitner (Saluda Medical) for contributions to an early draft of the manuscript.

Declaration of interest

LP reports consultancy fees from Medtronic, Saluda Medical and Nalu outside the submitted work. AF is a consultant for Saluda Medical. PSS reports consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic outside the submitted work, and has stock options from Saluda Medical and Nalu.

Reviewer disclosures

A review on this manuscript has disclosed that they own shares in Neuromodulation Specialists Ltd, a small start-up medical device company in London, UK. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/17434440.2023.2255520.

Additional information

Funding

No funding was received in support of this study.