Second Sight Scores Date With FDA for Review of Retina Prosthesis System
Published: Jul 20, 2012
RP, an inherited retinal degenerative disease that often results in nearly complete blindness, affects roughly 100,000 Americans and has been designated by the World Health Organization as an orphan disease. In 2009, the Argus II prosthesis received a Humanitarian Use Designation (HUD), making it a candidate for an HDE approval which is intended to expedite the market introduction of technologies intended to treat smaller, underserved patient populations.
The system works by converting video images captured by a miniature camera, housed in the patient's glasses, into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina's remaining cells resulting in the corresponding perception of patterns of light in the brain. Patients then learn to interpret these visual patterns thereby regaining some functional vision.
The data presented in the HDE application will be discussed by the advisory panel. If FDA market approval is granted, the Argus II system will become the first ever retinal prosthesis to gain approval in the U.S. The system became the only approved retinal prosthesis anywhere in the world when it received CE Mark approval in Europe last year.
About Second Sight
Second Sight Medical Products Inc., located in Los Angeles, California, was founded in 1998 to create a retinal prosthesis to provide sight to patients blinded from outer retinal degenerations, such as Retinitis Pigmentosa. Through dedication and innovation, Second Sight's mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence. While the Argus II system is CE-marked in Europe it is not yet approved for sale in the United States. European Headquarters are in Lausanne, Switzerland. For more information, go to www.2-sight.com .
SOURCE: Second Sight Medical Products Inc.