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Argus II users accumulate implant time since FDA approval
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KOLOA, Hawaii — Since the U.S. Food and Drug Administration approval of the Argus II retinal prosthesis, 35 subjects have been implanted at 10 surgical centers for a cumulative implant time of 140-plus subject-years, a speaker reported here.
The Argus II (Second Sight Medical Products) is used in cases of profound retinitis pigmentosa and consists of an external camera, transmitter and video processing unit and an internal receiver and electrode array that are placed with standard vitreoretinal surgery techniques as a retinal prosthetic.
Clinical trials are underway for expanded indications, Mark S. Humayun, MD, a co-inventor of the device said at Retina 2014, with the first patient in the U.S. being implanted last week at the University of Michigan.
Mark S. Humayun
“These devices are expensive, even to manufacture; $10,000 is the very, very basic cost,” Humayun said.
Since FDA approval, only two serious adverse events have occurred, whereas 14 were reported in clinical trials.
“A lot have to do with hypotony and conjunctival dehiscence,” Humayun said. “Where the cable goes in, it requires a little bit of suturing and meticulous Tenon’s closure.”
Worldwide there are more than 70 Argus patients, Humayun said, and post-market surveillance study is underway. —by Daniel Morgan
Disclosure: Humayun is a stock shareholder in Bausch + Lomb, Replenish and Second Sight; he is a consultant for Alcon Laboratories, Regenerative Patch Technologies, Replenish and Second Sight; and he receives research funds from Bausch + Lomb, Replenish and Second Sight.