The First Phase of an FDA Clinical Trial is Completed for the World’s First Commercial Artificial Retina Device
The DOE Artificial Retina Project has successfully completed the first phase of an FDA clinical study designed to evaluate the safety of the world’s first commercially available artificial retina device -- the Argus II. Nine blind patients have been implanted with Argus II in 4 medical centers around the US. As of today, no adverse effects have been detected, all 9 blind patients are able to see light and other visual stimuli, and there have been no device failures. Due to these exceptional results, FDA has granted approval for these patients to use the device at home in a non-laboratory environment.
The Argus II is a 60 electrode device that incorporates revolutionary DOE national laboratory technology. This device, which has been design to last a lifetime, is more compact and contains nearly 4 times the number of electrodes as the initial 16 electrode device – the Argus I. (The Argus I is the only retinal prosthesis developed worldwide that continues to operate in patients after more 5 years of use – all other retinal implants operate less than 6 weeks in patients).
What’s unique about the DOE implants is that they have been engineered to last a lifetime and visual information is processed on the chip in real time—which allows patients to better function in their environment. In both the US and in Europe, plans are underway to implant additional patients with the Argus II device.
Contact: Dean Cole, SC-23.2, (301) 903-3268
SC-23.2 Biological Systems Science Division, BER
(formerly SC-23.2 Medical Sciences Division, OBER)
BER supports basic research and scientific user facilities to advance DOE missions in energy and environment. More about BER
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