Second Sight Receives FDA Approval to Begin Feasibility Study of Orion Cortical Visual Prosthesis System

September 1, 2017: By Joan McKenna

Second SightSecond Sight, maker of the Argus II retinal prosthesis system, announced Aug. 28 that it has received conditional approval from the US FDA to begin a feasibility study of its Orion Cortical Visual Prosthesis System.

The Sylmar, California, company may enroll up to five patients in total at two US sites: the University of California at Los Angeles and Baylor College of Medicine in Houston. The FDA has requested that the firm conduct additional device testing and address outstanding questions within 45 days.

Will McGuire, president and CEO of Second Sight, said in a statement: “The Orion team has met all major internal milestones this year, and we remain on track to achieve the company’s stated goal of implanting our first Orion patient before year end.”

Second Sight’s Orion is designed to convert images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses. The Orion transmits these electrical pulses wirelessly to an array of electrodes implanted on the surface of the visual cortex. By bypassing the retina and optic nerve and directly stimulating the visual cortex, a cortical prosthesis system has the potential to restore useful vision to patients blinded due to many reasons, including glaucoma, diabetic retinopathy, or forms of cancer and trauma, the company said.

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