Sunday, July 16, 2006

We Can Rebuild Him - After We Get FDA Approval



In a recent
posting I discussed how I had found the Bionic Ear Institute while traveling in Melbourne, Australia. I hadn't thought much about bionics since the days of Steve Austin, the Six Million Dollar Man.



But apparently Australia will remain the place to be for bionic implants. That's because the U.S. Food and Drug Administration's ophthalmic devices panel recommended against approving a tiny pea-sized bionic telescope for implantation into the eyes of some elderly patients. The device,
called the Implantable Miniature Telescope, has a telephoto lens that can enable some patients to do away with the special glasses and handheld telescopes they now use to compensate for the loss in central vision caused by age-related macular degeneration, according to VisionCare Ophthalmic Technologies Inc., its manufacturer.

The recommendation against approval came despite clinical trials
in which 141 of 193 patients implanted with the device showed both improved distance and near visual acuity after one year. Only ten patients reported a loss in acuity in either distance or near vision. Doctors removed eight of the devices, four of them from patients dissatisfied with how they worked, FDA documents show.

If you have macular degeneration, you're going to have to look to Australia for some relief. I highly recommend going there even if you can't get Rudy Wells to give you a bionic eye.

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