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The Hydrus Microstent Ivantis HYDRUS IV United States Clinical Trial

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1. How does the Hydrus work?

The Hydrus™ Microstent is designed to treat the high intraocular pressure (IOP) that is common in patients with POAG. In which pressure in the eye increases because the eye’s fluid path becomes blocked. The tiny Hydrus “scaffold” is designed to be inserted into the primary fluid canal (called Schlemm’s canal) of the eye and we gently dilate the channel to allow blocked fluid to flow more freely, thus alleviating high IOP.

2. What is the Hydrus Microstent made of?

The Hydrus is made of a unique, biocompatible alloy called “nitinol”, made of two components, nickel and titanium. A nitinol implantable device has special characteristics, like its flexibility and its ”shape memory”, making it a commonly

used material for medical applications. In fact, nitinol devices have been implanted in over one million cases in different areas of the body, including blood vessels, bones, and other applications.

3. Is the Hydrus therapy available in the U.S.?

The Hydrus Microstent is investigational only and is not for sale in the U.S. The Hydrus is part of an FDA approved clinical study, and only in combination with cataract surgery.

4. What are the risks associated with the Hydrus procedure?

Like any surgical procedure, the Hydrus procedure has potential risks as well as potential benefits. Talk with your study doctor about the possible risks and benefits of the Hydrus procedure.

5. Can I have Hydrus implanted in both of my eyes?

The Hydrus Microstent is available as part of an investigational study and is being studied in one eye only. However, there are other available therapy options for your other eye. Please talk with your doctor about these other options.