Argus II becomes first "bionic eye" to gain approval for sale in U.S.
While the word prosthesis usually evokes images of artificial legs, arms, and these days even sophisticated thought-controlled hands, an entirely new class of replacement body part has now become a reality – the bionic eye. One of the pioneers in this field is California-based Second Sight and the company has now announced that its Argus II System has received U.S. market approval from the Food and Drug Administration (FDA).
The result of two decades of R&D and US$200 million in public and private investment, the Argus II System began clinical trials in the U.S. back in 2007 and won approval for sale in Europe in 2011.
The system is designed to treat near blindness caused by retinitis pigmentosa – a degenerative disease said to affect approximately 100,000 Americans. It consists of a tiny video camera mounted in glasses that is wirelessly linked to a receiver and microelectrode array implanted onto the patient's retina. This microelectrode array, which spans 20 degrees of the visual field, then stimulates the remaining cells in the retina with electrical pulses that travel down the optic nerve to the brain. While it does not restore normal sight, patients can learn to interpret these signals and gain a significant increase in visual capabilities to the point where they can perceive colors, recognize large letters and locate objects.
“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. In the patients that have been implanted to date, the improvement in the quality of life has been invaluable,” said Mark Humayun, MD, PhD, Cornelius Ping’s Professor of Biomedical Engineering, Professor of Ophthalmology, Biomedical Engineering, Cell and Neurobiology, Doheny Eye Institute at University of Southern California. “The fact that many patients can use the Argus implant in their activities of daily living such as recognizing large letters, locating the position of objects, and more, has been beyond our wildest dreams, yet the promise to the patients is real and we expect it only to improve over time.”
The Argus II is expected to become available later this year. “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," said Robert Greenberg, MD, PhD, President and CEO of Second Sight.
The Second Sight video below runs us through how the Argus II system works.
Source: Second Sight
Please keep comments to less than 150 words. No abusive material or spam will be published.