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FDA panel votes retinal prosthesis system safe for use
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The U.S. Food and Drug Administration’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted 17-2 that there is a reasonable assurance the Argus II Retinal Prosthesis System is safe.
The Argus II Retinal Prosthesis System (Second Sight) is intended to induce visual perception in patients who are blind through the use of electric stimulation to the retina, according to the FDA’s executive summary of the device.
The Argus II is indicated for patients with severe to profound retinitis pigmentosa with bare or no light perception in both eyes. To be eligible for the prosthesis system, patients must have functional ganglion cells and optic nerve in the implanted eye and a history of useful vision in their worse-seeing eye.
Thirty patients have been implanted with the Argus II thus far, with a minimum follow-up of 36 months. Median surgery time was 4 hours.
According to the executive summary, “A total of 23 serious and 140 non-serious device- or procedure-related adverse events were reported in the study. Four subjects accounted for many of the adverse events due to a cascade of related events. In total, they accounted for 57% of all [serious adverse events] and 24% of all non-serious adverse events.”
Endpoints and probable benefits of the clinical trials were defined as an improvement in visual acuity, as well as improvements in functional vision and quality of life, according to the executive summary supplied to the FDA by Second Sight.
The panel voted 18-1 that the Argus II provides probable benefit to patients and 19-0 that the probable benefits outweigh the risks of the device.
References:
- FDA executive summary. Accessed Sept. 28, 2012.
- Second Sight sponsor executive summary. Accessed Sept. 28, 2012.