iStent^® Important Safety Information

INDICATIONS FOR USE

The iStent^® Trabecular Micro-Bypass System is intended to reduce intraocular pressure safely and effectively in patients diagnosed with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with cataract surgery in those subjects who require intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment with glaucoma medications and conventional glaucoma surgery.

CONTRAINDICATIONS

The iStent^® Trabecular Micro-Bypass Stent is contraindicated under the following circumstances or conditions: In eyes with primary angle-closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because the device would not be expected to work in such situations. 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/PRECAUTIONS:

This device has not been studied in patients with uveitic glaucoma. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. iStent^® is MR-Conditional meaning that the device is safe for use in a specified MRI environment under specified conditions, please see labeling for details. Physician training is required prior to use and consists of 3 parts: webinar, didactic session with Glaukos surgical representative and observation of surgical cases by Glaukos representative until implantation proficiency is demonstrated. Do not re-use the stent(s) or inserter.

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%). Please refer to Directions for Use for additional adverse event information.

CAUTION

Please reference the Directions for Use labeling for a complete list of contraindications, warnings, precautions, and adverse events.