Wednesday, January 10, 2007
Second Sight Medical Retinal Prosthesis Receives FDA Approval for Clinical Trials
Filed under: Neurological Surgery
, Ophthalmology
, Regulation
2nd Sight Medical has just received USFDA investigational device exemption (IDE) to begin clinical trials for their Argus II Retinal Prosthesis System.
In case you haven't been following Second Sight, their retinal prosthesis uses an array of electrodes to stimulate the retina, restoring a low level of vision in patients with degenerative diseases. Their first implant had 16 electrodes, the new Argus II has 60...
The Argus II implant consists of an array of electrodes that are attached to the retina and used in conjunction with an external camera and video processing system to provide a rudimentary form of sight to implanted subjects. An IDE trial of the first generation implant (Argus™ 16), which has 16 electrodes, is ongoing at the Doheny Eye Institute at the University of Southern California. The Argus 16 was implanted in six RP subjects between 2002 and 2004 and has enabled them to detect when lights are on or off, describe an object's motion, count discrete items, as well as locate and differentiate basic objects in an environment. Five of these subjects are now using their Argus 16 retinal prostheses at home.
The next generation Argus II retinal stimulator is designed with 60 independently controllable electrodes, which should provide implanted subjects with higher resolution images. Second Sight remains the only manufacturer with an actively powered permanently implantable retinal prosthesis under clinical study in the United States, and the technology represents the highest electrode count for such a device anywhere in the world.
More from Second Sight's main page, their clinical trials page, and their full press release...
Flashbacks: Second Sight Implant: Positive Results Reported in the Study; Diamond Coating for Second Sight Implant
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