欧洲已经批准美国第二视力公司的治疗视网膜色素变性的人工视网膜在欧洲上市治疗，治疗先在英国、法国、瑞士的4个医院进行，下面是英语的详细介绍。
Artificial Retina Receives European Marketing Approval
The Argus II Retinal Prosthesis System, an implantable device that provides useful vision to people who are blind from advanced retinal degenerative diseases such as retinitis pigmentosa, will be available later this year in Europe.
The Argus II received European marketing approval as a result of a successful three-year, 30-participant international clinical trial, which demonstrated the device’s long-term performance, safety, and reliability. It is the first artificial retina to receive marketing approval anywhere in the world. Second Sight Medical Products, developer of the Argus II, will also be seeking marketing approval for the device in the U.S.
The Argus II has enabled people who are profoundly blind to see shapes, locate objects, and recognize large letters. The retinal prosthesis system captures images from a miniature video camera mounted on a pair of sunglasses and converts them into electronic impulses that are sent to a 60-electrode chip attached to the retina. Users of the device perceive patterns of light, which they learn to interpret as vision.
“Second Sight’s artificial retina is giving people with advanced retinal disease the ability to function more independently,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “It is innovative technology that’s providing meaningful benefits to people who have no other options for improving their vision. I am very excited to see the device move out of clinical research into the marketplace.”
The Argus II will cost approximately $100, 000 U.S. Second Sight is working to obtain insurance coverage for the device and the surgical procedure (estimated to be $15,000 U.S.) to install it.
Second Sight reports that the Argus II is approved for persons meeting the following criteria:
•age 25 years or older
•severe to profound outer retinal degeneration
•some residual light perception or a retina that can respond to electrical stimulation
•previous history of useful form vision
The Argus II will be available later this year at the following clinical centers:
•Centre Hospitalier National d’Ophthalmologie des Quinze-Vingts (Paris, France)
•Hôpitaux Universitaires de Genève (Geneva, Switzerland)
•Manchester Royal Hospital (Manchester, United Kingdom)
•Moorfields Eye Hospital (London, United Kingdom)
The Foundation Fighting Blindness funded early, preclinical studies of this artificial retina technology. |
