Orion, the Cortical Visual Prosthesis System, gets full FDA approval

(c) medgadget.com

The FDA has granted full approval to Second Sight Medical Products (SSMP) to begin the feasibility study for the Orion-I^TM Cortical Visual Prosthesis System. The approval allows two US sites, the University of California at Los Angeles (UCLA) and Baylor College of Medicine in Houston, to enroll up to five total patients. The company’s new Orion I Visual Cortical Prosthesis goes even further by bypassing the optic nerve, along with the entire visual system, and stimulates the brain’s visual cortex directly. This would allow even people who lack any functionality within their eyes to be able to see.

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Please read the disclaimer here.

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For decades, scientists have been trying to develop brain implants to give sight back to the blind but have had limited success. If the Second Sight device works, it could help millions of blind patients worldwide, including those who have lost one or both eyes.


What is Orion^TM?

(c) Second Sight Medical Products

Orion system utilizes similar concept at the Argus II (of which the author is one of the co-inventors), where images captured by a miniature video camera mounted on the patient's glasses are converted into a series of small electrical pulses. These pulses are then wirelessly transmitted to an array of electrodes implanted on the surface of the visual cortex (the part of the brain that serves vision) (rather than on the retina as in the case of Argus II) , with the intention of the subject perceiving patterns of light.

By bypassing the retina and optic verve altogether, with the visual cortex being stimulated directly from the camera, this technology has the potential to restore useful vision to patients completely blinded due to a significant number of eye diseases, including glaucoma, diabetic retinopathy and ocular trauma. But it is likely to be useful for those who had vision before but have lost it from almost any cause, who could potentially be helped by the Orion I technology. Those who have never seen are unlikely to benefit, at least until we know more of this technology and the outcomes.

Back in October 2016, SSMP had announced successful first ever implantation and activation of the OrionTM in a 30-year old subject operated on at UCLA, who was able to perceive and localize individual phosphenes or spots of light. Surgery did not cause any adverse side effects in this subject.

The approach will likely restore the same degree of vision as the Argus II, possibly a little more. Most patients with bionic eyes have had limited sight, such as being able to distinguish light from dark and to recognize outlines of objects in their view, but color perception has been difficult. Patient experiences also vary from one individual to another. Some have been able to read small letters, such as newspaper headlines, but others have not.

A major issue with this device is that it requires a much more invasive surgery than say an Argus II. Operating to place the device on the occipital cortex requires a small section of the skull to be removed to expose the area of the brain where the array of electrodes are placed. Because electrical brain implants carry risks like infection or seizures, which was observed in some of the early cortical implants in the last century, the first clinical trial is testing the device only in a small number of subjects.

Cortical or a brain implant is more difficult to make it work right than a retinal implant primarily because the visual cortex is so much more complicated than the eye. Scientists are still in the early days of understanding how the brain processes images to produce vision and how neurons extract information from the visual cortex. It is quite possible that the Orion implants might help us answer these questions to some degree. Another issue with side stepping the eye is that majority of visual processing is considered to take place at the retinal level. Since the visual information is now directly being fed to the visual cortex, it is not clear at this time what quality of vision will the subjects see with these implants.

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References: Second Sight Press Release; medGadget; MIT Technology Review