The life-changing artificial retina by Second Sight has today been given the go-ahead by European officials, making it the world's first to actually go on sale, to anyone who needs it. Well, anyone with $US100,000 spare, that is.
Those that fork out for the artificial retina must don glasses, with a tiny camera hidden inside actually transmitting electrical pulses into the retina. It will obviously take some adjustment, learning to read the signals that are sent from the eye to the brain, but tests so far seem to be overwhelmingly positive.
I don't want to mention the words "Repo" and "Men" in the same sentence, but we're slowly getting there, aren't we?
Lausanne, March 2, 2011 - After more than 20 years of research and development involving a team of international specialists, Second Sight Medical Products, Inc., the leading developer of retinal prostheses for the blind, is pleased to announce that its Argus II Retinal Prosthesis System ("Argus II") is now approved for sale in the European Economic Area (EEA). After a successful clinical trial involving more than 30 blind patients around the world, and a very thorough review of the product's safety and performance by an independent expert body, this device becomes the first approved treatment ever available for sightless people.
"After years of research, we are very happy to be able to offer a viable long-term solution for people suffering from advanced retinal degenerative diseases such as retinitis pigmentosa (RP)," said Robert Greenberg, MD, President and CEO of Second Sight. "The CE Mark approval, which comes after intense regulatory review of our trial and our device, represents a huge step forward for the field and for these patients who have, until now, had no proven treatment alternatives."
Argus II is Second Sight's second generation implantable device intended to treat profoundly blind people suffering from degenerative diseases such as RP. The system works by converting video images captured from 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 retina. These pulses then stimulate the retina's remaining cells resulting in the corresponding perception of patterns of light in the brain. Patients learn to interpret these visual patterns thereby gaining some functional vision. Thirty patients participated in the clinical trial, using the device at home and in their daily lives since the trial started.
Although the resulting vision is far from normal, investigators in the clinical trial of the Argus II are excited by the results. "After more than 3 years of clinical trials, we were happy to demonstrate the performance, safety and long-term reliability of Argus II," explained Professor José-Alain Sahel, Chairman, Department of Ophthalmology: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France. Adds Dr. Lyndon da Cruz, MD PhD Consultant Retinal Surgeon at Moorfields Eye Hospital in London, UK " The fact that nearly all patients had a stable, safe and functioning system and that a majority of patients could recognise large letters, locate the position of objects and the best could read short words impressed us beyond our most optimistic expectations'
With this CE Mark approval, the Argus II is planned to be available later this year in the following clinical centers: Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts (Paris, France), Hôpitaux Universitaires de Genève (Geneva, Switzerland), Manchester Royal Eye Hospital (Manchester, UK), and Moorfields Eye Hospital, (London, UK). Second Sight is actively adding sites to make the therapy more readily available across the EEA in the coming months and years. The company is also focused on obtaining insurance coverage for the device and surgical procedure.
"This ‘artificial retina' brings hope to thousands of people with advanced retinal diseases" added David Head, Chief Executive of the British Retinitis Pigmentosa Society. "The restoration of an element of vision may bring with it the restoration of independence and mobility that would greatly improve a patient's quality of life."
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. Argus II is not yet approved for sale in the United States. European Headquarters are in Lausanne, Switzerland.