Figure 1: The Evoke System – Clinical Interface (top left), external closed loop stimulator (eCLS) charger (top right), bottom left to right: lead extension, implantable closed loop stimulator (CLS) with leads, eCLS with leads, remote control
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Saluda Medical Evoke® Spinal Cord Stimulation (SCS) System
PMA Applicant: Saluda Medical Pty Ltd.
Address: Level 1, 407 Pacific Highway, Artarmon, New South Wales 2064, Australia
Approval Date: February 28, 2022
Approval Letter: Approval order
What is it?
The Evoke Spinal Cord Stimulation (SCS) System (Evoke System) is an implanted, rechargeable spinal cord stimulation system intended to treat long-term (chronic) pain in the trunk or limbs that is difficult to manage (intractable).
The main components of the Evoke System include an implanted signal generator that is connected to one or two implanted leads and a remote control that can turn the stimulator ON or OFF to allow adjustments of therapy settings.
How does it work?
Spinal cord stimulation consists of applying an electrical stimulus to the spinal cord to relieve chronic pain. The Evoke System is designed to operate in either of two modes:
- In open-loop (fixed-output) stimulation mode, the implanted signal generator receives radio signals from the remote control. The signals tell the implanted signal generator when to deliver appropriate stimulation through the implanted leads to the spinal cord. The external remote control is battery operated and can be controlled by the patient or a health care provider to manually adjust stimulation levels. The level of stimulation is fixed once it is set using the remote control.
- In closed-loop stimulation mode, the health care provider uses the remote control to set a target level of spinal cord activation. In closed-loop mode, the Evoke System measures the spinal cord activation level after every electrical pulse. Based on the activation level, it can automatically adjust the stimulation current to maintain consistent spinal cord activation.
When is it used?
The Evoke SCS System is used as an aid to manage chronic pain in the trunk or limbs, including one-sided or two-sided pain associated with failed back surgery syndrome, intractable low back pain, or leg pain.
What will it accomplish?
The Evoke SCS System may help to treat chronic, intractable pain in the trunk and/or limbs.
When should it not be used?
The Evoke SCS system should not be used in patients who:
- Cannot operate the SCS system
- Have not received effective pain relief during trial stimulation
- Are poor SCS surgical candidates
Additional information (including warnings, precautions, and adverse events):