The first FDA-approved retinal prosthesis, approved under a Humanitarian Device Exemption in February 2013 and now discontinued. Thinly sourced from the FDA HDE record and Cortigent; electrode specifications are not on this sheet yet.
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.
Argus II retinal prosthesis
Argus II is an epiretinal implant for blind patients with retinitis pigmentosa. FDA authorized it under a Humanitarian Device Exemption on February 13, 2013, and Cortigent says it is discontinued. This sheet is thin: it rests on the HDE record and the Cortigent page, so electrode and performance cells stay Unreported. Orion, the cortical visual prosthesis, is investigational and gets its own sheet.
Identity
Field
Value and source scope
Device
Argus II Retinal Prosthesis System: epiretinal implant with an eye-worn electronics case and antenna, glasses-mounted camera and external video processing unit [1][2]
Manufacturer
Second Sight Medical Products, now Cortigent, Inc. [2]
Interface class
Epiretinal implant stimulating the retinal surface [2]
Cortigent says Argus II launched in 2011, with EU approval in March 2011 [2]
First human implant
Unreported
Species studied
Human [1]
Regulatory status
HDE H110002: received May 4, 2011, approved February 13, 2013; European approval March 2011. Cortigent states Argus II is discontinued and no longer available. HDE authorization means probable benefit, and effectiveness was not demonstrated [1][2]
Function
Electrical stimulation of the retina to induce visual perception in blind patients with severe to profound retinitis pigmentosa and bare or no light perception in both eyes [1][2]
Target tissue
Retina; the company says activity reaches the brain via the optic nerve [2]
Geometry and architecture
Field
Value and source scope
Interface type
Microelectronic implant applied to the retinal surface, with an electronics case and antenna fixed to the outer surface of the eye [2]
Array layout
Unreported
Electrode count
Unreported
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
Data processing unit converts camera images into small electrical pulses [2]
Data path
Images from a miniature camera on glasses are processed externally and sent wirelessly to the retinal implant [2]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Unreported
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
Unreported
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
Unreported
Preclinical cohort
Unreported
Follow-up duration
Unreported
Indications
Adults aged 25 or older with severe to profound retinitis pigmentosa and bare or no light perception in both eyes (the order statement lists further criteria not extracted here) [1]
Trials and registries
Unreported [1]
Primary outcomes
Unreported
Key limitations
Electrode count, stimulation parameters and clinical outcomes were not in the sources read. The HDE and later supplements (S001 to S033) were not reviewed [1]
Engineering tradeoffs
Field
Value and source scope
Strengths
Unreported
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
The HDE has 33 supplements (S001 to S033) listed on the FDA record; the sheet describes the system at the level of the original approval order and company page.