FDA Approves Device For Patients With Retinitis Pigmentosa.
The Food and Drug Administration's approval of a new device for patients with retinitis pigmentosa (RP) received heavy coverage in print and online, and was featured on two of last night's national news broadcasts. Most articles quote one or more FDA officials, and many point out that the National Eye Institute partially funded research on the device. Many sources also point to the innovative nature of the device and the potential benefits the device may hold for individuals with RP.
NBC Nightly News (2/14, story 5, 1:30, Williams) reported, "The FDA has approved the first-ever artificial, in effect, bionic eye."
The CBS Evening News (2/14, story 7, 0:20, Pelley) reported that the agency "says it may help victims of" RP "detect light and dark."
USA Today (2/14, Winter) reports that the device, called the Argus II Retinal Prosthesis System, "consists of a small video camera and transmitter mounted on eyeglasses. The camera processes images into electronic data that is wirelessly transmitted to electrodes implanted into the retina." USA Today adds, "The FDA approval came under the 'humanitarian use' category, which is limited to devices that annually treat or diagnose fewer than 4,000 people in the United States."
In a front-page story, the New York Times (2/15, A1, Belluck, Subscription Publication) reports, "'This is just the beginning,' said Grace Shen, a director of the retinal diseases program at the National Eye Institute, which helped finance the artificial retina research and is supporting many other blindness therapy projects." The Times also quotes Dr. Malvina Eydelman, the FDA's director for the Division of Ophthalmic and Ear, Nose, and Throat Devices, who said, "It's a big step forward for the whole ophthalmology field."
The Wall Street Journal (2/15, B3, Wang, Jones, Subscription Publication) reports that the device will likely be available in the US later in 2013. It is already been approved in Europe.
The Los Angeles Times (2/14, Healy) "Booster Shots" reports, "The gadget took more than two decades to develop, and" its maker, "Second Sight, got early funding from the Department of Energy, the National Science Foundation and the National Eye Institute to develop it. It is the first of many visual prosthetic devices under development, but the first to have demonstrated the capability to hold up under long-term implantation in the human eye."
In a front-page story, the Washington Post (2/15, A1, Dennis, Sun) reports, "The approval marks a milestone in the research of retinal diseases, which affect millions of Americans." The agency "says that while the device will not fully restore patients' vision, 'it may allow them to detect light and dark in the environment,' which could help them perform daily tasks."
The Financial Times (2/15, Rappeport, Subscription Publication) reports that, according to Dr Jeffrey Shuren, 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."
Bloomberg News (2/15, Edney) reports, "A clinical study of 30 people showed the eye device helped patients recognize large letters or words, detect street curbs, walk on a sidewalk without falling and match black, gray and white socks."
The AP (2/14) reports, "Second Sight hopes to eventually win approval to treat a wide variety of vision disorders, including macular degeneration, the leading cause of blindness in developed countries." Also covering the story are AFP (2/15), Reuters (2/15, Steenhuysen), the Atlantic Wire (2/15, Estes), HealthDay (2/15, Reinberg), MedPage Today (2/15, Fiore) and Medscape (2/15, Roach).
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