Second Sight Medical Products, the world’s only developer and manufacturer of an approved retinal prosthesis for the blind, won a date with the FDA to consider humanitarian device exemption status for its Argus II system.
On Sept. 28, 2012, the FDA’s ophthalmic devices panel will review the application for the Argus II device for patients aged 25 and older who have severe to profound retinitis pigmentosa, experience bare or no light perception in both eyes and have "previous history of useful form vision."
The Argus II is a "bionic eye" system using a head-worn video camera to capture a scene, which is processed by a computer and sent to an implant that stimulates cells in the retina.
The implant, which may be surgically place in one or both eyes, includes an antenna, an electronics case and an electrode array, according to the company’s website. The external equipment includes glasses, a video processing unit and a cable.
The FDA’s HDE approval system is designed to incentivize development in devices that treat conditions affecting 4,000 or fewer people in the U.S. each year. The application system is similar to the pre-market approval process with the exception that the device maker isn’t held to the same efficacy standards as long as the device can demonstrate safety.
The Argus II won CE Mark approval in the European Union last year. The device is currently undergoing a 3-year U.S. clinical trial, expected to enroll 30 patients and close in July 2014, according to regulatory filings.
