In February 2022 FDA approved Saluds Medical’s Evoke® Spinal Cord Stimulation (SCS) System (Evoke System), which is an implanted, rechargeable spinal cord stimulation system intended to treat chronic, intractable pain in the trunk or limbs.
The Evoke® System automatically adjusts stimulation to maintain precise and consistent neural activation with breathing, coughing, positional changes and activity to keep a patient at their prescribed stimulation dose.
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.
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.