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FDA Approves Electronic Artificial Retina Implant Device

Robert Greenberg and Barbara Campbell hold U.S. patent no. 8 million (A. Kotok)

Robert Greenberg and Barbara Campbell hold U.S. patent no. 8 million (A. Kotok)

The U.S. Food and Drug Administration approved the first implant device to restore some visual perception for adults with retinitis pigmentosa, a genetic disease that damages the retina. The Argus II Retinal Prosthesis System is made by Second Sight Medical Products Inc. in Sylmar, California.

Retinitis pigmentosa is an eye disease caused by genetic defects that damages cells affecting night vision, and sometimes periperal and central vision, in the retina, leading to blindness. The retina is the layer of tissue at the back of the inner eye that converts light images to nerve signals and sends them to the brain. The condition affects about 1 in 4,000 people in the U.S.

The Argus II uses a tiny video camera mounted on glasses to capture images that are then transformed with a processing unit and sensors into electronic signals sent to the retina to produce images. The system restores perception of light and movement, not full eyesight, and is intended for adults age 25 or older with advanced cases of retinitis pigmentosa. To receive the system, patients must have an intact and functioning inner retinal layer, and previous history of the ability to see forms.

FDA approved the system as a humanitarian use device, a pathway for devices that treat or diagnose fewer than 4,000 people in the U.S. each year. The approval was based in part on a clinical trial with 30 retinitis pigmentosa patients Argus II system. The results showed most participants were able to perform basic activities better with the system than without it. Those activities tested included locating and touching a square on a white field,  detecting the direction of a motion, and walking on a sidewalk without stepping off.

Most — 19 of the 30 participants — experienced no adverse affects, but 11 patients did report 23 different events that included retinal detachment and erosion of the conjunctiva, the clear covering of the eyeball.

In August 2011, Second Sight Medical Products received the 8 millionth patent awarded by the U.S. Patent and Trademark Office for the technology behind the Argus device. In a event marking that patent in September, reported by Science Business, CEO Robert Greenberg (pictured at top with a patient using the system) said the company has another 180 patents pending.

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