FEB 15, 2013
FDA
The FDA has approved the Argus II Retinal Prosthesis System, the first retinal implant for adults with advanced retinitis pigmentosa. Second Sight Medical Products plans to make the Argus II available in the U.S. later this year.
The system includes an external video camera, video processing unit and transmitter mounted on a pair of eyeglasses, along with electrodes implanted internally onto the patient's retina. The video processor wirelessly transmits images captured from the camera as a series of electrical pulses to the electrodes, stimulating retinal cells to produce images.
While vision is not restored, patients can learn to interpret the pulses to regain some visual function, such as detecting light and dark or seeing movement.
"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," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health. "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."
Originally approved in the U.S. as a humanitarian use device, it is intended for 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 system was approved in Europe in 2011 and received a unanimous recommendation from the FDA's Ophthalmic Devices Advisory Panel in September 2012.