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: Hydrus® Microstent
PMA Applicant: Ivantis, Inc.
Address: 38 Discovery, Suite 150 Irvine, CA 92618
Approval Date: August 10, 2018
Approval Letter: Approval Order
What is it? The Hydrus® Microstent is an implantable, flexible, metal (nitinol) tube with windows (open-back stent) pre-loaded onto a hand-held delivery system. The Hydrus® Microstent is intended to reduce eye pressure (intraocular pressure, or IOP) in adult patients with mild to moderate primary open angle glaucoma (POAG) by acting as a support structure in one part of the natural drainage pathway of the eye (Schlemm's canal). POAG is a type of glaucoma where there is no other associated eye disease causing increased eye pressure and where the eye pressure usually rises slowly. This gradual increase in eye pressure can be associated with damage to the optic nerve.
How does it work? The Hydrus® Microstent is implanted into the eye of glaucoma patients to help fluid in the front part of the eye (anterior chamber, or AC) flow more freely through Schlemm's canal.
When is it used? The Hydrus® Microstent is intended to be used during cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate POAG.
What will it accomplish? In a clinical study of 369 participants, 77.2% who received the Hydrus® Microstent achieved a 20% or greater reduction in their IOP compared to 57.8% (108/187) of the participants having cataract surgery alone.
When should it not be used? The Hydrus® Microstent should not be used in patients who have any of the following conditions:
- When the colored part of the eye (iris) is pushed up against the drainage pathway or when other material blocks the drainage pathway (angle closure glaucoma);
- Traumatic glaucoma, malignant glaucoma, or inflammation of the eye tissue (uvea);
- Glaucoma associated with the growth of abnormal blood vessels in the eye (neovascular); or
- Noticeable birth irregularities of the anterior chamber (AC) angle.
Additional information (including warnings, precautions, and adverse events):