The U.S. health regulator approved the first implantable device for treating a rare, genetic, eye disease that can lead to blindness.
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The device, made by Sylmar, California-based Second Sight Medical Products Inc, includes a small video camera, a transmitter mounted on a pair of eyeglasses, a video processing unit and an implanted artificial retina.
The video processing unit transforms images from the video camera into electronic data that is wirelessly transmitted to the retina inside the eye.
The eye disease, called retinitis pigmentosa (RP), damages the light-sensitive cells that line the retina, resulting in the gradual loss of side vision and night vision, and later of central vision.
The device is named Argus II and is intended for use in adults aged 25 years or older with bare or no light perception in both eyes, an intact inner layer retina function and a previous history of the ability to see forms, FDA said.
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