The device is not cheap -- in Europe, where the device has been approved for use for several years, it typically costs about $100,000, with an additional $16,000 for the operation. The company hasn't set a U.S. price yet, but Greenberg say it is going to exceed $100,000.
Insurance typically covers the cost in several European countries, and the company has started a process to get it covered in the United States, Greenberg said.
To gain FDA approval, the system had to go through a clinical trial to see if the device was both safe and effective. The results showed that most participants could perform basic activities better with the device than without.
Activities tested included locating and touching a square on a white field; detecting the direction of a motion; recognizing large letters, words or sentences; detecting street curbs; walking on a sidewalk without stepping off; and matching black, gray and white socks, according to the FDA.
Among the 30 people in the study, 19 had no adverse events related to the implant surgery.
Eleven patients, however, did experience serious problems. These included erosion of the layer covering the eyeball called the conjunctiva, opening of the wound left by the operation, retinal detachment, inflammation and low pressure in their eyeball, the agency noted.
For more information on retinitis pigmentosa, visit the U.S. National Library of Medicine.
SOURCES: Mark Fromer, MD, ophthalmologist, Lenox Hill Hospital, New York City; Robert Greenberg, M.D., Ph.D., president, CEO, Second Sight Medical Products, Inc.; FDA Blog post, William Maisel, M.D., M.P.H., Deputy Director, Science and Chief Scientist, Center for Devices and Radiological Hea
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