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  • 平井 将秀


The Food and Drug Administration (FDA) approved the first retinal implant for use in the United States. The FDA’s green light for Second Sight’s Argus II Retinal Prosthesis System gives hope to those blinded by a rare genetic eye condition called advanced retinitis pigmentosa, which damages the light-sensitive cells that line the retina.


For Second Sight, FDA approval follows more than 20 years of development, two clinical trials and more than $200 million in funding. The Argus II has been approved for use in Europe since 2011 and implanted in 30 clinical-trial patients since 2007. The FDA’s Ophthalmic Devices Advisory Panel in September 2012 voted unanimously to recommend approval.

セコンドサイト社にとってこのFDA承認は、20年以上の開発と2件の臨床試験、そして2億ドル以上の資金援助を経て獲得したものです。欧州ではアーガスⅡの使用が2011年に認められ、2007年以降臨床試験で30名の患者に移植が行われてきました。2012年9月に開催されたFDAのOphthalmic Devices Advisory Panel(眼科用医療機器諮問委員会)では、承認の推奨が全会一致で支持されています。

The Argus II includes a small video camera, a transmitter mounted on a pair of eyeglasses, a video processing unit and a 60-electrode implanted retinal prosthesis that replaces the function of degenerated cells in the retina, the membrane lining the inside of the eye. Although it does not fully restore vision, this setup can improve a patient’s ability to perceive images and movement, using the video processing unit to transform images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis.


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