视力恢复的人工视网膜获得FDA批准

福娃晶晶

抗盲基金会网站消息：

2013年2月14号-阿格斯II视网膜假体，一种装置，可以恢复部分视力的人是盲目的，从先进的视网膜色素变性（RP），市场已获得美国食品和药物管理局（FDA）的批准。第二视力医疗产品开发，设备将在今年晚些时候在全国各地的约10个临床中心。在2011年，阿格斯II 在欧洲的销售许可。也被称为一个“仿生视网膜，”它是目前世界上唯一的视网膜假体与监管部门的批准。

走进阿格斯II的发展超过20年的研究。该基金会战斗失明起到了开创性的作用，在其发展的早期版本的设备的实验室研究提供资金。“博士说：”这确实是一个令人振奋的历史时刻，在驱动器与先进的视网膜变性疾病的人，对恢复视力斯蒂芬·罗斯，基金会的首席研究官。阿格斯II“在一定程度上恢复了基本的视觉，给人的独立性，流动性，并最终提高生活质量。” 阿格斯II的外置摄像头安装在一副太阳镜，视觉图像发送到60电极栅由外科手术植入在视网膜上。该网格将这些图像转换成电信号，被送回的大脑。该设备的用户感知光的图案，大脑学习解释为视觉。设备，使临床试验的参与者是深刻双目失明，视网膜变性，看形状，识别大字母，并显着改善流动性。在2012年9月，一组行业专家，第二视力代表和6名用户的阿格斯II参加的FDA听证会要求建议的销售许可。该用户的发言令人信服地有关设备如何改善他们的导航能力和完成日常任务。院长劳合社，是完全盲目的从RP的律师，告诉他高兴的是，在排序白色，灰色和黑色的袜子，由于阿格斯II面板，成本和可用性的阿格斯II将提供进一步的信息。第二视力在今年晚些时候。该公司正在积极寻求保险赔偿的制度。第二 ​​视力是在开发一个240电极的视网膜假体的设计，使用户能够感知更详细的早期阶段。临床可用性是几年的时间，在此期间，公司拟以提高患者的阿格斯II的性能升级的相机和软件的外部磨损系统的一部分，了解更多关于阿格斯II和它的历史从眼睛的固化博客后写的博士罗伯特·格林伯格，二视线的首席执行官。和阅读的积极影响的阿格斯II有一个人的生活，检查出这个故事。有关的阿格斯II或学习，如果你可能是一个候选此设备，请致电第二视力医疗产品服务热线855-756-3703（免费电话）或818-833-5027。

福娃晶晶

Vision-Restoring Retinal Prosthesis Receives FDA Approval
Feb. 14, 2013 – The Argus II retinal prosthesis, a device that can restore some vision to people who are blind from advanced retinitis pigmentosa (RP), has received U.S. market approval from the Food and Drug Administration (FDA). Developed by Second Sight Medical Products, the device will be available later this year in approximately 10 clinical centers across the country. In 2011, the Argus II received marketing approval in Europe. Also known as a “bionic retina,” it is currently the world’s only retinal prosthesis with regulatory approval.

More than 20 years of research went into the development of the Argus II. The Foundation Fighting Blindness played a seminal role in its development by funding laboratory studies for an earlier version of the device.

“This is truly an exciting and historic moment in the drive to restore vision in people with advanced retinal degenerative diseases,” says Dr. Stephen Rose, chief research officer of the Foundation. “By restoring some basic vision, the Argus II gives people independence, mobility and, ultimately, improved quality of life.”

The Argus II consists of an external video camera mounted on a pair of sunglasses which sends visual images to a 60-electrode grid surgically implanted on the retina. The grid converts those images to electrical signals, which are sent back to the brain.

Users of the device perceive patterns of light, which the brain learns to interpret as vision. The device has enabled clinical trial participants who are profoundly blind from retinal degeneration to see shapes, recognize large letters and significantly improve mobility.

In September 2012, a group of industry experts, Second Sight representatives and six users of the Argus II attended an FDA hearing to request recommendation for marketing approval. The users spoke compellingly about how the device improved their ability to navigate and accomplish daily tasks. Dean Lloyd, an attorney who is completely blind from RP, told the panel about his delight in being able to sort white, grey and black socks, thanks to the Argus II.

Further information about costs and availability of the Argus II will be provided by Second Sight later this year. The company is actively pursuing insurance reimbursement for the system.

Second Sight is in the early stages of developing a 240-electrode retinal prosthesis designed to enable users to perceive more detail. Clinical availability is years away, and, in the meantime, the company intends to boost patient performance of the Argus II by upgrading the camera and software of the externally worn part of the system.

Read more about the Argus II and its history from an Eye on the Cure blog post written by Dr. Robert Greenberg, Second Sight’s chief executive officer. And to read about the positive impact the Argus II had on one man’s life, check out this story.

For more information on the Argus II or to learn if you may be a candidate for this device, call the Second Sight Medical Products hotline at 855-756-3703 (toll free) or 818-833-5027.