The Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel has scheduled to review the data presented in the Second Sight Medical Products' humanitarian device exemption (HDE) market approval application, for its Argus II Retinal Prosthesis system, on 28 September 2012.
The Argus II System is indicated for use in patients with severe to profound retinitis pigmentosa.
The HDE application includes the results of a multi-center clinical trial conducted in patients suffering from end-stage retinitis pigmentosa.
The Argus II prosthesis system, which received a humanitarian use designation in 2009, is intended to expedite the market introduction of technologies to treat smaller, underserved patient populations.
The system converts video images captured by a miniature camera into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina to stimulate the retina's remaining cells resulting in the corresponding perception of patterns of light in the brain.
The company said if FDA market approval is granted, the Argus II system will become the first retinal prosthesis to gain approval in the US.
