SALUDA MEDICAL Evoke, Clinical Manual

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Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 4 of 61
1 Description
The Saluda™ Medical Evoke™ System is a Spinal Cord Stimulation (SCS) system that can
measure the Evoked Compound Action Potential (ECAP) and may provide consistent
stimulation based on the subject’s neural response during physiological changes and
movement by automatically adjusting the level of stimulation current required to meet the
subject’s requested target level.
The Evoke System may be used in conjunction with other pain management therapies, as
determined by the physician.
The Evoke System comprises several key components to deliver the therapy.
Table 1.1: Description of Evoke System components
Name: Evoke Closed-Loop Stimulator (CLS)
Catalogue Number: 0002, 2002
The Evoke Closed-Loop Stimulator (CLS) is a totally implanted spinal cord stimulator
that connects to the leads and is implanted under the skin for long-term therapy.
The CLS delivers stimulation through the leads and measures the neural response to
stimulation.
Name: Evoke External Closed-Loop Stimulator (eCLS)
Catalogue Number: 0020, 2020
During the trial stimulation period, the leads are connected to the Evoke External
Closed-Loop Stimulator (eCLS). The eCLS is an external stimulator worn during the
trial stimulation period. The eCLS delivers stimulation through the leads and
measures the neural response to stimulation.
Name: Evoke 12C Percutaneous Leads
Catalogue Number:
0008, 2008, 2026 (lead length 60 cm)
0016, 2016 (trial lead length 60 cm)
0009, 2009, 2027 (lead length 90 cm)
0017, 2017 (trial lead length 90 cm)
The Evoke 12C Percutaneous Leads are placed in the epidural space overlying the
spinal cord and are connected to an eCLS for a trial stimulation period or to a CLS for
long-term therapy.
One or two leads with 12 electrodes on each lead are implanted.
Name: Evoke Lead Adapter Kit
Catalogue Number: 2028
The Evoke Lead Adapter, Lead Adapter Cable and Lead Adapter Extension allow you
to connect the eCLS to the implanted leads.
Name: Evoke Pocket Console (EPC)
Catalogue Number: 0003, 2003
The Evoke Pocket Console (EPC) allows the patient to control their therapy and
actively monitors Stimulator battery status and other elements of the system. The
EPC and the Stimulator communicate with each other wirelessly.