The U.S. Food and Drug Administration (FDA) Ophthalmic Devices Panel recently reviewed and approved the groundbreaking ARGUS II Retinal Prosthesis System. Manufactured by Second Sight Medical Products, Inc., the device will allow partial vision restoration to patients who are blind due to Retinitis Pigmentosa (RP). This is the first treatment for this condition that is now FDA approved. A 23-member panel of experts unanimously voted that the probable benefit of the ARGUS II Retinal Prosthesis System outweighs risks to health.RP, an inherited retinal degenerative disease often results in nearly complete blindness and affects 100,000 Americans.
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. Patients then learn to interpret these visual patterns thereby regaining some visual function.