Argus retinal prosthesis
The Argus retinal prosthesis is an electronic retinal implant produced by the California-based company Second Sight. It is designed primarily to improve the vision of those with severe cases of the inherited disease retinitis pigmentosa. In March 2011, the Argus II version of the system was approved for clinical and commercial use in the European Union. In February 2013, the Argus II became the first commercial visual prosthesis to be approved for use in the United States.
The system restores low vision in functionally blind patients. The best visual acuity outcomes in clinical trials were 20/1260 and significant gains were observed. Additionally, 11 of 30 subjects experienced adverse events but all were treated and the device remained functional. In the commercial setting, the incidence of side effects has been reported to be much lower. [Humayun ASRS 2013 presentation]
As of March 2014 in commercial use and clinical trials, the Argus II system has been implanted into over 80 people. The best result achieved by the device was a visual acuity of 20/1260, where blindness is defined as greater than 20/500 by the World Health Organization, and as 20/200 in the United States. Thus, while vision has been improved, no cases of actual blindness have been resolved by the device. In the commercial setting, better visual acuities have been reported (i.e. 20/1000). Although the system does not take patients above the threshold for legal blindness, it does provide significant improvements in orientation and mobility and the ability to see other people. Furthermore, the device is proven to be highly reliable with only two device failures to date (an additional two systems have been removed for safety reasons). The longest user of the Argus II is approaching 7 years while the closest competitive device has not demonstrated a device lifetime beyond 1 year.
The Argus II is primarily designed to treat sufferers of retinitis pigmentosa, a genetic ocular disease that affects approximately 1.5 million people worldwide. The device consists of two primary elements – a retinal implant and an external system consisting of an eyeglass-mounted camera in combination with a small processor. The camera records real-time images, which are processed and sent wirelessly to the implant by a built-in video processor. The implant then uses 60 electrodes to stimulate the patient's remaining healthy retinal cells and send visual information to the optic nerve, thus restoring the ability to discern light, movement, and shapes. In some cases, the Argus II can restore sufficient vision to allow blind users to read large print books. As of 2013[update], the Argus II has a unit cost of around US$100,000.
The Argus II received approval for commercial use in the European Union in March 2011. It is available at a limited number of clinics in France, Germany, Italy, Netherlands, UK and Saudi Arabia, and has an EU market price of $115,000. In 2013, the FDA approved the Argus II as a "humanitarian use device," authorizing its use for up to 4,000 US patients per year. In February 2013, the FDA approved the Argus II as a "humanitarian use device", authorizing its use for up to 4,000 US patients per year. In August 2013, Second Sight announced that reimbursement payments had been approved for the Argus II for blind Medicare recipients in the United States. The Argus II was officially launched in the United States in January 2014.
Company history and development
The implant's developer, Second Sight, was founded in Sylmar, California, in 1998, although low-level research and design efforts began in 1991. The first version of the prosthesis, the Argus I, was developed in 2002, and clinically tested on six patients. The second version, the Argus II, was first tested in Mexico in 2006. Thereafter, a 30-patient clinical trial was conducted in ten medical centers across Europe and the United States.
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