IStent for Glaucoma

The iStent is the first device that improves the patient's natural fluid outflow to safely lower eye pressure by creating a permanent opening in the trabecular meshwork. Proven safe and effective, the iStent Trabecular Micro-Bypass is implanted during cataract surgery, spares important eye tissue that is often damaged by traditional surgeries and does not limit treatment options that could help maintain your vision in the future.

The iStent is the smallest medical device ever approved by the FDA. It is placed in the patient's eye during cataract surgery and is so small that you won’t be able to see or feel it after the procedure is over. The iStent is designed to create a permanent opening in your trabecular meshwork, and works continuously to improve the outflow of fluid from your eyes to help control eye pressure.

For patients with combined cataract and open-angle glaucoma, the iStent reduces introcular pressure (IOP) by improving aqueous humor outflow. Inserted through a 1.5-mm corneal incision, iStent is the only FDA-approved device for the treatment of mild to moderate open-angle glaucoma.

INDICATION FOR USE

The iStent Trabecular Micro-Bypass Stent (Models GTS100R and GTS100L) is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication.

CONTRAINDICATIONS

The iStent is contraindicated in eyes with primary or secondary angle closure glaucoma, including neovascular glaucoma, as well as in patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.

WARNINGS

Gonioscopy should be performed prior to surgery to exclude PAS, rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. The iStent is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified conditions, please see label for details.

PRECAUTIONS

The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the iStent has not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, chronic inflammation, or an abnormal anterior segment, in pseudophakic patients with glaucoma, in patients with pseudoexfoliative glaucoma, pigmentary, and uveitic glaucoma, in patients with unmedicated IOP less than 22 mmHg or greater than 36 mmHg after “washout” of medications, or in patients with prior glaucoma surgery of any type including argon laser trabeculoplasty, for implantation of more than a single stent, after complications during cataract surgery, and when implantation has been without concomitant cataract surgery with IOL implantation for visually significant cataract.

ADVERSE EVENTS

The most common post-operative adverse events reported in the randomized pivotal trial included early post-operative corneal edema (8%), BCVA loss of ≥ 1 line at or after the 3 month visit (7%), posterior capsular opacification (6%), stent obstruction (4%) early post-operative anterior chamber cells (3%), and early post-operative corneal abrasion (3%).

CAUTION

Federal law restricts this device to sale by, or on the order of, a physician. Please reference the Directions for Use labeling for a complete list of contraindications, warnings, precautions, and adverse events.