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Jan 15, 2007

Second Sight Medical Retinal Prosthesis Receives FDA Approval for Clinical Trials

From Medgadget


2nd sight implant...those are some expensive sunglasses

2nd Sight Medical has just received USFDA investigational device exemption (IDE) to begin clinical trials for their Argus II Retinal Prosthesis System:


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.

retinal implant by Second Sight


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.


Read the full press release