FDA approves first artificial retina for rare genetic eye condition
The first artificial retina has been approved by the US FDA, which will help restore vision in patients with a rare genetic disorder. The Argus II Retinal Prosthesis System has been approved to treat adult patients with the rare genetic eye condition, advanced retinitis pigmentosa (RP). This rare disease damages the light-sensitive cells that line the retina and can lead to blindness.
The device includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted retinal prosthesis (artificial retina), which replaces the function of degenerated cells in the retina and may improve a patient’s ability to perceive images and movement. The VPU then can transform images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis.
“This new surgically implanted assistive device provides an option for patients who have lost their sight to RP – for whom there have been no FDA-approved treatments. The device may help adults with RP who have lost the ability to perceive shapes and movement to be more mobile and to perform day-to-day activities.”
Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
The development of the Argus II Retinal Prosthesis System, by California-based Second Sight Medical Products, was supported by three Government organisations. The Department of Energy, National Eye Institute at the National Institutes of Health and the National Science Foundation collaborated to provide grant funding totalling more than US $100 million, support for material design and other basic research for the project.
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