This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Glaukos iStent® Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and Inserter (GTS-100i)
PMA Applicant: Glaukos Corporation
Address: 26051 Merit Circle, Suite 103, Laguna Hills, CA 92653
Approval Date: June 25, 2012
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf8/p080030a.pdf
What is it? The iStent® is a tiny L-shaped device made of titanium. It is 1 millimeter long and 0.33 millimeters high and is pre-loaded in the inserter of the iStent® for implantation inside the eye.
How does it work? The iStent® is designed to increase the flow of fluid out of the eye. When properly implanted inside the eye, it creates a direct path for fluid to flow between the fluid-filled chamber of the front of the eye and the major collector channel that directs fluid out of the eye bypassing the meshwork of tissue through which the fluid normally flows.
When is it used? The iStent® is implanted inside the eye during cataract surgery (surgery to remove the natural lens that has become cloudy and caused significant vision loss) in adults with mild to moderate open-angle glaucoma being treated with medications to reduce eye pressure.
What will it accomplish? The iStent®is used to decrease the eye pressure of patients with open-angle glaucoma. Open-angle glaucoma is an eye disease that results in damage to the nerve of the eye (the optic nerve) and permanent vision loss due to the pressure inside the eye being too high.
When should it not be used?
- The iStent®should not be used in eyes with angle-closure glaucoma, where the fluid is prevented from leaving the eye because the angle of the eye, where the fluid normally drains out, gets closed off.
- The iStent® should not be implanted in patients with any condition that causes high pressure in the veins into which the collector channels of the eye drain the fluid, such as thyroid eye disease, a tumor behind the eye, or a “port-wine stain” birthmark involving the upper eyelid caused by an abnormal collection of small vessels near the eye.
Additional Information: The Summary of Safety and Effectiveness Data and labeling are available online.