Retinal Implant Approved by US Food & Drug Administration
19 February 2013
Second Sight's Argus® II Retinal Prosthesis System has become the first approved such device in the US. The company claim "life-changing potential" for the treatment of blindness due to retinitis pigmentosa.
After more than 20 years of research and development, Second Sight Medical Products has announced that its Argus II retinal prosthesis has received U.S. market approval from the Food & Drug Administration (FDA) to treat individuals with late stage RP.
“We are thrilled to be able to offer the only FDA-approved long-term therapy for people suffering from advanced RP,” said Robert Greenberg, President and CEO of Second Sight.
"Argus II is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals with retinitis pigmentosa and has the capacity to offer life-changing visual capabilities to those currently unable to see anything except, at best, extremely bright lights."
It is important to note that artificial vision is not the same as normal vision, but investigators involved in the trials describe this approval as "incredibly exciting".
"In the patients that have been implanted to date, the improvement in the quality of life has been invaluable,” said Professor Mark Humayun at the University of Southern California.
With approval from the FDA, the device is slated to be available later this year in clinical centres across the USA.
FDA approval came following more than 20 years of work in the field, two clinical trials, over $100M in public investment by the National Eye Institute, the Department of Energy, and the National Science Foundation, and an additional $100M in private investments.
The Argus II System works by converting video images captured by 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 surface of the retina. These pulses are intended to stimulate the retina’s remaining cells resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns thereby regaining some visual function. Second Sight also secured European approval (CE Mark) for the system in 2011.
Note: This article is based on press releases received from Second Sight, the full text of which is linked below.
After more than 20 years of research and development, Second Sight Medical Products has announced that its Argus II retinal prosthesis has received U.S. market approval from the Food & Drug Administration (FDA) to treat individuals with late stage RP.
“We are thrilled to be able to offer the only FDA-approved long-term therapy for people suffering from advanced RP,” said Robert Greenberg, President and CEO of Second Sight.
"Argus II is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals with retinitis pigmentosa and has the capacity to offer life-changing visual capabilities to those currently unable to see anything except, at best, extremely bright lights."
It is important to note that artificial vision is not the same as normal vision, but investigators involved in the trials describe this approval as "incredibly exciting".
"In the patients that have been implanted to date, the improvement in the quality of life has been invaluable,” said Professor Mark Humayun at the University of Southern California.
With approval from the FDA, the device is slated to be available later this year in clinical centres across the USA.
FDA approval came following more than 20 years of work in the field, two clinical trials, over $100M in public investment by the National Eye Institute, the Department of Energy, and the National Science Foundation, and an additional $100M in private investments.
The Argus II System works by converting video images captured by 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 surface of the retina. These pulses are intended to stimulate the retina’s remaining cells resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns thereby regaining some visual function. Second Sight also secured European approval (CE Mark) for the system in 2011.
Note: This article is based on press releases received from Second Sight, the full text of which is linked below.
