FDA-approved closed-loop spinal cord stimulator that records ECAPs through two 12-contact leads, approved February 2022. Values come from the FDA summary of safety and effectiveness.
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
Saluda Evoke closed-loop SCS
The Saluda Evoke System records evoked compound action potentials from the spinal cord after every pulse. This sheet comes from the FDA summary for PMA P190002. Clinical result values were not read and stay Unreported.
Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia [1][2]
Interface class
Rechargeable 25-channel SCS pulse generator that records evoked compound action potentials and runs in closed-loop or open-loop mode [2]
Origin
Commercial FDA-approved device, PMA P190002 [1]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Unreported
Regulatory status
PMA P190002 approved February 28, 2022, with no panel recommendation. The SSED states it was approved in Europe and not yet marketed in the United States at the time of the summary [1][2]
Function
Measures ECAPs after every stimulation pulse and adjusts stimulation to a target ECAP in closed-loop mode, or delivers fixed output in open-loop mode [2]
Target tissue
Dorsal column spinal cord fibers via epidural leads [2]
Geometry and architecture
Field
Value and source scope
Interface type
Percutaneous leads introduced through an epidural needle; ECAPs are measured on the non-stimulating contacts [2]
Array layout
Two 12-contact leads; 80 mm electrode span [2]
Electrode count
12 electrodes per lead; the CLS connects to two leads (24 epidural electrodes) plus the case [2]
Pitch
4 mm edge-to-edge spacing [2]
Electrode lengths
Lead length 60 or 90 cm [2]
Shank width and thickness
Lead diameter 1.32 mm [2]
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Epidural needle with straight or bent stylets; subcutaneous tunneling to the CLS pocket [2]
Anchoring and fixation
Suture anchors and active anchors secure the lead to the supraspinous ligament or deep fascia [2]
Electrode and channel physics
Field
Value and source scope
Exposed site area
12.44 mm2 per electrode [2]
Electrode material
Platinum/iridium [2]
Impedance (with measurement frequency)
Lead conductor resistance under 16 ohm; measurement frequency not given. This is lead resistance, not electrode-tissue impedance [2]
Noise floor or SNR
Unreported
Recording modality
ECAPs recorded on non-stimulating contacts after each stimulation pulse; the CLS case may be used for recording only [2]
Sampling rate
Unreported
Stimulation capability
25 channels; symmetrical rectangular biphasic or triphasic pulses; 10-1500 Hz open loop and 10-250 Hz closed loop; bipolar or multipolar paths [2]
Charge injection limit
Unreported
Reference and ground
Unreported
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Unreported
Insertion trauma and BBB disruption
Unreported
Vascular disruption risk
Unreported
Micromotion sensitivity
Unreported
Gliosis and encapsulation
Unreported
Neuron loss near sites
Unreported
Foreign-body response mitigation
Unreported
Typical failure modes
Unreported
System architecture
Field
Value and source scope
Onboard electronics
CLS generates stimulation and measures ECAPs; lithium-ion rechargeable battery [2]
Data path
Clinical Interface tablet with a Clinical System Transceiver (USB) wirelessly programs the CLS; Pocket Console for patient adjustments within clinician limits [2]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Lithium-ion rechargeable battery charged transcutaneously by a charger; Pocket Console uses disposable batteries [2]
Thermal management
Unreported
Packaging and hermeticity
CLS hermetic helium leak limit 6.6 x 10^-8 std cc/s per acceptance criteria [2]
MRI compatibility
Not established in the SSED text read; the pivotal exclusion criteria excluded patients likely to need MRI or diathermy [2]
Surgical complexity
Percutaneous lead placement, lead extension if needed, and a CLS pocket [2]
Output connectors
Unreported
Performance envelope
Field
Value and source scope
Acute yield
Unreported
Chronic yield
Unreported
Stability over time
Unreported
Longevity
Unreported
Revision and explant experience
Unreported
Adverse events
SSED lists labeled risks including infection, CSF leak, epidural hemorrhage, lead migration and loss of pain relief; study event rates are in section X.D.1, not extracted here [2]
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
Evoke pivotal study: prospective, multicenter, randomized (1:1), double-blind trial of closed-loop versus open-loop stimulation; enrollment count not extracted here [2]
Preclinical cohort
27 sheep in an acute study of dorsal column neurophysiology and evoked-potential recording [2]
Follow-up duration
Unreported
Indications
Aid in the management of chronic intractable pain of the trunk and/or limbs, including failed back surgery syndrome, intractable low back pain and leg pain [2]
Trials and registries
Evoke pivotal study per the SSED; registry ID not extracted here [2]
Primary outcomes
Primary objective: non-inferiority of closed-loop to open-loop SCS on trunk and limb pain; result values were not read here [2]
Key limitations
Efficacy numbers, enrollment and event rates sit in SSED sections not extracted for this sheet [2]
Engineering tradeoffs
Field
Value and source scope
Strengths
Records ECAPs after each pulse to hold stimulation at a target neural response [2]
Limitations
Unreported
Scaling constraints
25 channels (24 electrodes plus case) [2]
Version boundary
The sheet describes the CLS and lead specifications as they appear in the 2022 SSED. Later supplements, if any, were not reviewed.