Investigational 60-electrode cortical surface visual prosthesis from Cortigent, tested in a six-subject early feasibility study. Not FDA approved. Separate from the discontinued Argus II retinal implant.
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.
Cortigent Orion visual cortical prosthesis
Orion is an investigational visual cortical prosthesis: a 60-electrode array on the medial occipital lobe driven by a wirelessly powered implant and camera glasses. It is not FDA approved. This sheet comes from the ClinicalTrials.gov record and company releases, so results are company-reported and electrode geometry is Unreported.
Identity
Field
Value and source scope
Device
Cortigent Orion Visual Cortical Prosthesis System: wirelessly powered and controlled implantable pulse generator connected to an array of 60 micro-electrodes, a belt-worn processing unit, and camera glasses [1][2]
Manufacturer
Cortigent, Inc., a wholly owned subsidiary of Vivani Medical; predecessor Second Sight Medical Products [1][2]
Interface class
Cortical surface electrode array on the medial occipital lobe [1][3]
Origin
Investigational device; not FDA approved [1][4]
First demonstrated
Early feasibility study started 2017 (ClinicalTrials.gov start date 2017-11-20); six subjects implanted between January 2018 and January 2019 [1][2][3]
First human implant
Unreported
Species studied
Human [2][3]
Regulatory status
Investigational; Cortigent says Orion is an investigative device not approved by FDA and plans a larger pivotal trial [2][4]
Function
Stimulates the surface of the visual cortex to induce visual perception in blind individuals; the processing unit converts a camera video stream into wireless stimulation commands [1][2]
Target tissue
Medial surface of the occipital lobe (visual cortex) [3]
Geometry and architecture
Field
Value and source scope
Interface type
Array of micro-electrodes designed for implantation on the brain surface of the visual cortex [1]
Array layout
Unreported
Electrode count
60 micro-electrodes (Vivani/Cortigent description); fewer than 4% of electrodes lost functionality over the study [1]
Pitch
Unreported
Electrode lengths
Unreported
Shank width and thickness
Unreported
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Unreported
Anchoring and fixation
Unreported
Electrode and channel physics
Field
Value and source scope
Exposed site area
Unreported
Electrode material
Unreported
Impedance (with measurement frequency)
Unreported
Noise floor or SNR
Unreported
Recording modality
Unreported
Sampling rate
Unreported
Stimulation capability
Unreported
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
Implantable pulse generator connected to the electrode array [1]
Data path
Wireless; belt-worn processing unit sends commands based on real-time video from camera glasses [1]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Wirelessly powered implant per the company description [1]
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Unreported
Surgical complexity
Unreported
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
One serious adverse event, a seizure, early in the study; none further after stimulation patterns were adjusted [1]
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
Six subjects with bare light or no light perception in both eyes, at two sites per Cortigent (UCLA and Baylor); the PI at the 2026 presentation was at UT Southwestern [2][3]
Preclinical cohort
Unreported
Follow-up duration
Study concluded March 2025; three devices explanted after 3-year visits and one at study end [1]
Indications
Unreported
Trials and registries
NCT03344848, Early Feasibility Study of the Orion Visual Cortical Prosthesis System. The registry lists ACTIVE_NOT_RECRUITING while the 2026 press release says the study concluded in March 2025 [1][3]
Primary outcomes
Company-reported: all subjects improved with the system on versus off in square localization and motion detection, and all had positive or mild positive final FLORA scores. No numeric scores given [1]
Key limitations
Six subjects; company-reported results; no electrode geometry, stimulation parameters or implant dimensions in the sources read. MRI, diathermy, ECT and TMS are contraindicated while implanted per the registry [1][3]
Engineering tradeoffs
Field
Value and source scope
Strengths
Unreported
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
One early feasibility configuration is described. A larger pivotal trial is planned but not started in the sources read.