SALUDA MEDICAL Evoke SCS System, Clinical Manual

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Evoke ® SCS System Clinical Manual
CLIN-UMAN-005175 Revision: 9.00
Page 5 of 101
1 Description
The Saluda® Medical Evoke® SCS System is a Spinal Cord Stimulation (SCS) system that
incorporates ECAP-controlled closed-loop stimulation for the management of chronic,
intractable pain. The Evoke System measures evoked compound action potentials (ECAPs) and
may be programmed to deliver either ECAP-controlled closed-loop SCS or fixed-output open-
loop SCS.
The Evoke Clinical Interface (CI) and Evoke Clinical System Transceiver (CST) enable the
programming of the implantable Closed-Loop Stimulator (CLS) and the non-implantable
External Closed-Loop Stimulator (eCLS).
The Evoke System may be used in conjunction with other pain management therapies, as
determined by the physician.
1.1 The concept of ECAP-controlled closed-loop SCS
The Evoke System uses ECAP amplitude to measure the patient’s neural response and provide
closed-loop (CL) SCS. The ECAP amplitude is a measure of the spinal cord activation or number
of dorsal column fibers in the spinal cord that are activated by a stimulation pulse. When
closed-loop is enabled, the system automatically varies the stimulation current for every pulse
to maintain consistent spinal cord activation during physiological changes and movement.
Figure 1.1, below, depicts the concept of an ECAP-controlled closed-loop system. Following a
stimulation pulse, the amplitude of the ECAP that is generated in the spinal cord by that
stimulus is recorded. The ECAP amplitude is compared to the selected target and then used to
automatically adjust the current of the next stimulus to maintain a consistent ECAP amplitude.
Figure 1.1: ECAP-Controlled Closed-Loop SCS.
1.2 Stimulation Features
The Evoke System provides the following advanced stimulation options.
1.2.1 Closed-loop SCS
When closed-loop is enabled, the system uses feedback of the ECAP amplitude to automatically
adjust the stimulation current of every pulse to maintain a target activation level. This ensures
consistent dorsal column activation during physiological changes and movement.