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FDA approves Argus II Retinal Prosthesis System
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The Argus II Retinal Prosthesis System from Second Sight Medical Products has been approved by the U.S. Food and Drug Administration.
The system, designed to treat adults with advanced retinitis pigmentosa, includes an external small video camera, video processing unit and transmitter fixed to eyeglasses, along with electrodes implanted internally onto the patient’s retina, according to an FDA press release.
The camera captures images and feeds them to the video processor, which then wirelessly transmits the information as a series of electrical pulses to the electrodes, stimulating retinal cells to produce images.
The system is not capable of restoring vision in its entirety, but patients can learn to interpret the pulses to regain some visual function, such as detecting light and dark or seeing movement.
The system was approved as a humanitarian use device, a designation meant for devices that treat or diagnose fewer than 4,000 people in the U.S. each year. It is intended for use in patients 25 years or older who have severe to profound retinitis pigmentosa, bare or no light perception, evidence of intact inner layer retina function, and a history of being able to see forms.
The Argus II should be available in the U.S. market later this year, according to a press release from Second Sight.
The device gained the CE mark in 2011 in Europe and received a unanimous recommendation from the FDA’s Ophthalmic Devices Advisory Panel in September 2012.