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The FDA Ophthalmic Devices Panel will meet Apr 24, 08 8:30 AM – 5:00 PM & Apr 25, 08 8:30 AM – 5:00 PM in the Gaithersburg Holiday Inn, Ballroom – 2 Montgomery Village Ave. Gaithersburg , MD
On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMTâ„¢). The IMTâ„¢, a visual prosthetic device, is indicated for monocular implant in patients with stable, moderate to profound central vision impairment due to bilateral central scotomas associated with end-stage macular degeneration with geographic atrophy or disciform scar, foveal involvement and cataract.
Since these diseases lead to central dysfunction of the retina the implantable telescope spreads the visual image over a larger area of normal retina.
The prosthetic telescope, together with the cornea, acts as a telephoto system to enlarge images 3X or 2.2X, depending on the device model used. The telephoto effect allows images in the central visual field (‘straight ahead vision’) to not be focused directly on the damaged macula, but over other healthy areas of the central and peripheral retina. This generally helps reduce the ‘blind spot’ impairing vision in patients with AMD
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