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Implant for Glaucoma Approved by FDA

August 3, 2016 By Transcend Medical

The FDA has approved the CyPass Micro-Stent from Transcend Medical, a device for treatment of mild to moderate primary open-angle glaucoma that is intended to be implanted along with cataract surgery. The stent creates a channel for liquids to flow out from the anterior chamber of the eye, thereby reducing the intraocular pressure.

The device rests in the supraciliary space between the sclera and the ciliary body. It’s in the shape of a cylinder that has an entry port on one end and a series of holes throughout its body that diffuse the liquid flowing through. The size of the device and the holes within it result in a set level of pressure below which nothing happens, but beyond which the liquid begins to move through the device.

In a study involving 505 patients—374 of which were implanted with the CyPass Micro-Stent device at the same time as cataract surgery and 131 that had cataract surgery alone—72.5 percent of patients who received the CyPass Micro-Stent achieved a significant lowering of their intraocular pressure (IOP) compared to 58 percent of patients who had cataract surgery alone. The lower IOP lasted through the 2-year-long study.

The CyPass Micro-Stent is currently limited to investigational use only.

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