iStent, the smallest medical device ever implanted into the human body, developed by ophthalmic medical device company Glaukos Corp., was approved by the FDA on Monday for use in combination with cataract surgery for the treatment of open-angle glaucoma.
Open-angle glaucoma, which is the most common form of glaucoma, is caused by the slow clogging of trabecular meshwork - the drainage canal of the eye, resulting in increased eye pressure, and is characterized by a wide and open angle between the iris and cornea.
Glaucoma cannot be cured, but a timely diagnosis will help prevent permanent vision loss. Eye drops that help maintain pressure in the eye at a healthy level are the most common treatments for glaucoma.
Glaukos' iStent, which weighs 60 µg and measures approximately 1 mm in length, becomes the first glaucoma stent for use with cataract surgery in the United States. The device is already approved for use in Europe.
The FDA approval was based on efficacy data from a study total of 240 eyes for 239 participants (one participant had both eyes evaluated). iStent was implanted in combination with cataract surgery for some of the study subjects while cataract surgery alone was performed in some of the study participants.
At one year following the procedure, 68 percent of participants with the iStent had the study target pressure of 21 millimeters of mercury or lower without the use of eye pressure-lowering medication, compared to 50 percent of participants who underwent cataract surgery alone.
Christy Foreman, director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health said, " The iStent is a new option that may be considered in the treatment of open-angle glaucoma in patients needing cataract extraction. This option may be considered earlier in the disease process than some other types of surgical glaucoma treatments."
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