Second Sight Retinal Prosthesis Approved for Sale in USA

February 15, 2013 - The Argus II Retinal Prosthesis System has received U.S. market approval from the Food and Drug Administration (FDA) to treat individuals with late stage retinitis pigmentosa (RP). This device captures images through a camera embedded in a pair of glasses and send electronic pulses to an implant on the retina.

Although the vision experienced by people who use this device in not equal to natural vision, a unanimous recommendation by the FDA’s Ophthalmic Devices Advisory Panel last fall was very positive. The expert reviewers stated that “The Argus II has the potential to provide life-changing vision capabilities as well as increased mobility and independence.” Based on this recommendation, the FDA has now approved the device for sale.

“With this approval, we look forward to building a strong surgical network in the United States and recruiting new hospitals that will offer the Argus II retinal implant,” says Dr. Robert Greenberg, President and CEO of Second Sight. Although US prices have not yet been set, the Argus II is now being marketed in Europe for about $100,000 USD, plus the costs of the surgery to implant it.

“It is incredibly exciting to have FDA approval to begin implanting the Argus II and provide some restoration of vision to patients blinded from RP,” says Dr. Mark Humayun, Professor of Biomedical Engineering at the University of Southern California, who was involved in the clinical trials of the device. “In the patients that have been implanted to date, the improvement in the quality of life has been invaluable.”

A Second Sight spokesperson said that Canada is on a “short list of countries where they hope to gain approval for the device.”

For more information, see the Foundation Fighting Blindness fact sheet on retinal prostheses.

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