BioWorld
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Second Sight wins IDE okay for 2nd-generation implant study

Jan. 12, 2007

A Medical Device Daily

Second Sight Medical Products (Sylmar, California) reported FDA approval of an Investigational Device Exemption (IDE) to conduct a study of its Argus II Retinal Prosthesis System.

The Argus II is the second generation of an electronic retinal implant designed for the treatment of blindness due to Retinitis Pigmentosa (RP), a group of inherited eye diseases that affect the retina. RP causes the degeneration of photoreceptor cells in the retina and progressive vision loss.

The Argus II implant consists of an array of electrodes 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 the company said it has enabled them to detect when lights are on or off, describe an object’s motion, count discrete items and locate “basic objects in an environment.” Five of these subjects are using their Argus 16 retinal prostheses at home.

The Argus II retinal stimulator features 60 independently controllable electrodes to provide implanted subjects with higher resolution images. Second Sight says it is only company with an actively powered, permanently implantable retinal prosthesis under clinical study in the U.S. It says the technology “represents the highest electrode count for such a device anywhere in the world.”

The study will be conducted in subjects who have a confirmed history of RP with remaining visual acuity of bare light perception or worse in both eyes with functional ganglion cells; a history of former useful vision; are age 50 or older; and can speak English.

Subjects will be followed for at least three years with visits to the implanting center up to two times per week. Enrollment will begin early this year, the company said.