The FDA has granted conditional approval to start a human feasibility clinical study of the Orion cortical visual prosthesis system, according to a press release from Second Sight Medical Products.
Up to five patients may be enrolled under the conditional approval.
In addition, the FDA has requested that Second Sight conduct more testing of the device and address questions. The company has 45 days to respond.
The concept of the device is to convert images captured by a miniature video camera mounted on a patient’s glasses into a series of small electrical pulses that will be transmitted wirelessly to electrodes implanted on the surface of the visual cortex, according to the release. The cortical prosthesis system has the potential to restore vision to completely blind patients by bypassing the retina and optic nerve and stimulating the visual cortex.
“We are delighted to have received conditional approval from the FDA to move forward and can now focus on finalizing the various approvals and agreements required at each clinical trial site,” Will McGuire, Second Sight president and CEO, said in the release. “Once we complete those steps, our designated U.S. clinical trial sites, the University of California at Los Angeles and Baylor College of Medicine in Houston, can begin patient recruitment efforts.”