The Argus II Retinal Prosthesis System is the first implanted device approved by the FDA to help restore some sense of sight to those over the age of 25 with advanced retinitis pigmentosa (RP).
RP is a rare genetic eye condition where people develop a progressive loss of vision that can result in blindness. About 100,000 Americans have retinitis pigmentosa, according to the New York Times, but only 10,000 to 15,000 people would qualify for the Argus II due to eligibility criteria.
Only those who are over the age of 25 and have a severe form of RP with “bare light or no light perception in both eyes but still have evidence of inner-layer retina function” would qualify reported Medcitynews.com.
The device was approved by the FDA as a humanitarian gesture but it does open the avenue for the future development of other devices that may help treat vision decline from ailments such a macular degeneration.
Humanitarian devices only need to show “probable benefit,” not proof of effectiveness said Dr. Malvina Eydelman, the FDA’s director for the Division of Ophthalmic and Ear, Nose, and Throat Devices. “It’s a big step forward for the whole ophthalmology field.”
“Of the 30 Argus II clinical trial patients, 11 experienced a total of 23 negative effects, the F.D.A. said, including retinal detachment and erosion of the clear covering of the eyeball” reported the New York Times.
The Argus II is the result of 20 years of research by Dr. Mark S. Humayun, an ophthalmologist and biomedical engineer at the University of Southern California and is produced by Second Sight Medical Products. It works by transmitting electric impulses translated by a video processor to the brain.
An “artificial retina” that contains electrodes and a receiver is implanted surgically on the eye. The person wears special eyeglasses that have a small video camera attached to the arm of the glasses.
Video images of what they are looking at are translated into electric impulses that are sent back wirelessly to the surgically implanted receiver on the eye. The impulses are then processed by the implanted electrodes and the remaining retinal cells. The optic nerve relays these patterns to be interpreted by the brain as an image.
“While the Argus II Retinal Prosthesis System will not restore vision to patients, it may allow them to detect light and dark in the environment, aiding them in identifying the location or movement of objects or people,” the FDA reported.
Currently the Argus II is available in Europe, after it was approved in 2011, for around 73,000 euros which is about $97,500 in the United States.
The New York Times reported that Argus II will initially be available at seven U.S. hospitals across the country for “about $150,000, excluding surgery and training. Second Sight said it was optimistic that insurance would cover it”.
Comments to the New York Times article mirrored extremes of response.
Some people were thrilled, amazed and in awe of the advancement of such a device that could be the first step in returning vision to the blind. Others were focused on cost, cost of healthcare in general and whether Obamacare would cover it.
It is important to note, the initial price is always higher when a new technology becomes available.
Hopefully, other advancements will follow making such a device appropriate and less costly for all those who once had sight and have lost it or even for those who were born without vision at all.
Sources:
Device Offers Partial Vision for the Blind. Newyorktimes.com. Web Feb 17, 2013.
http://www.nytimes.com/2013/02/15/health/fda-approves-technology-to-give...
Beyond the hype of the FDA’s approval of the first bionic eye. Medcitynews.com. Web Feb 17, 2013.
http://medcitynews.com/2013/02/beyond-the-hype-of-the-fdas-approval-of-t...
FDA NEWS RELEASE. FDA approves first retinal implant for adults with rare genetic eye disease. For Immediate Release: Feb. 14, 2013. Retrieved Feb 17, 2013.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm339824.htm
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles
Edited by Jody Smith