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FDA approves trial for artificial retina device
SYLMAR, Calif. — The Food and Drug Administration has granted an investigational device exemption for a trial of the implantable Argus II Retinal Prosthesis System in patients with retinitis pigmentosa, according to Second Sight Medical Products, the device's manufacturer.
The study will require patients to be followed up at least twice each week for at least 3 years, according to a press release from Second Sight. Enrollment will begin in early 2007.
The Argus II is a second-generation retinal stimulator with 60 independently controllable electrodes connected to an external camera, providing "a rudimentary form of sight" to patients, according to the release. The Argus II improves upon an earlier model, which is currently being evaluated in a clinical trial, by providing higher resolution images, the release said.