Argus II Retinal Prosthesis Implanted for the First Time Commercially in Europe
November 3, 2011 – A retinal prosthesis known to many as “the bionic retina” was implanted for the first time commercially in a patient in a hospital in Pisa, Italy, on October 29. Called the Argus II Retinal Prosthesis System, it was surgically implanted by Dr. Stanislao Rizzo, director of the University Hospital Ophthalmic Department of Pisa, who reports that the patient, who has an advanced form of retinitis pigmentosa, is recovering quite well.
The Argus II received European marketing approval several months ago as the result of a three-year international clinical trial, which demonstrated the device’s long-term safety, performance and reliability. It’s the first artificial retina to receive marketing approval anywhere, and its developer, Second Sight Medical Products, is currently seeking FDA approval in the United States.
The Argus II consists of a 60-electrode grid that is surgically implanted on the retina, where the electrodes transmit information taken from an external video camera mounted on a pair of eyeglasses worn by the user. The device has enabled clinical trial participants who are profoundly blind, due to damaged photoreceptors, to see shapes, locate objects and recognize large letters. Users of the device perceive patterns of light, which they learn to interpret as vision.
“Second Sight’s artificial retina is truly innovative technology, which enables people with advanced retinal diseases to function more independently,” says Dr. Stephen Rose, the Foundation’s chief research officer. “The Foundation funded pre-clinical work that allowed this technology to advance, so to know that it has been successfully implanted in the first patient is exciting."
Over the next couple of weeks, according to Dr. Rizzo, the implanted Argus II will be tested and customized for the patient. If the process, which includes training and rehabilitation, goes well, the patient may be using the device at home by the end of this month.
As its name indicates, the Argus II is a second-generation version of the device, which, originally, had a 16-electrode grid. Playing a crucial role in the device’s development, the Foundation funded the first version at the pre-clinical stage. The name Argus, according to Second Sight, comes from Greek mythology. Argus Panoptes, a giant with 100 eyes, was considered all-seeing.
译文如下：呵格斯II代视网膜假体在欧洲第一次以商品形式被植入病人
2011年11月3日讯
2011年10月29日，在意大利比萨一所医院，视网膜假体，也就是大家所知的“仿生视网膜”，被第一次以商品形式植入病人。它称为阿格斯II代视网膜假体系统，由Stanislao Rizzo博士主刀植入一位患重度视网膜色素变性的病人。Stanislao Rizzo博士为比萨大学医眼科主任，报道这位患者恢复良好。
几个月前，阿格斯二代获得欧洲市场准入，这是三年国际临床试验的结果，显示了这个装置的长期安全性、性能与可靠性。它是第一个被批准上市的人工视网膜，它的升级版，名为千里眼医学产品，目前正在申请美国FDA的批准认可。
阿格斯二代包括一个60个电极组成的网栅，网栅经手术植入视网膜，通过网栅内的电极传送信息，信息由固定在使用者眼镜上的外在摄像机采集。这个装置能使临床试验参与者看见形状，定位物体与辩认大字母，而且这些临床试验参与者为光感受器损坏引起的重度失明。装置使用者认知感光模式，并学会用视觉来解释。
基金会首席研究专家Stephen Rose博士说：“千里眼人工视网膜是一种真正的创新技术，它能使患重度视网膜疾病的人行动更独立。基金会对这项技术临床前研究工作的资助推动其向前发展，所以它成功地植入第一例病人是一个振奋人心的消息。”
据Rizzo博士所说，在接下来的几周里，植入的阿格斯二代将根据病人进行调试和个体用户化。如果训练与用户化过程进行得顺利，到这个月月末病人可以在家使用这个装置。
顾名思义，阿格斯二代是第二代视觉装置，最初的只有16个电极。基金会对这个装置的发展起重要作用，资助了最初版的临床前研究。根据千里眼，阿格斯这个名字来源于希腊神话。Argus Panoptes，有100只眼睛的巨人，是无所不见的。
