The Argus II Retinal Prosthesis System includes a small video camera, a transmitter mounted on a pair of eyeglasses, a video processing unit and an implanted retinal prosthesis, or artificial retina, which replaces the function of degenerated cells in the retina and may improve a patient's ability to perceive images and movement.
Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, said the video processing unit transforms images from the video camera into electronic data that are wirelessly transmitted to the retinal prosthesis.
Retinitis pigmentosa is a rare genetic eye condition that damages the light-sensitive cells that line the retina. In a healthy eye, these cells change light rays into electrical impulses and send them through the optic nerve to the area of the brain that assembles the impulses into an image.
The light-sensitive cells slowly degenerate in those with retinitis pigmentosa, resulting in gradual loss of side vision and night vision, and later of central vision. The condition can lead to blindness.
"This new surgically implanted assistive device provides an option for patients who have lost their sight to retinitis pigmentosa -- for whom there have been no FDA-approved treatments," Shuren said in a statement. "The device may help adults with retinitis pigmentosa who have lost the ability to perceive shapes and movement to be more mobile and to perform day-to-day activities."
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