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: iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
PMA Applicant: Glaukos Corporation
Address: 229 Avenida Fabricante, San Clemente, CA 92672
Approval Date: June 21, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170043a.pdf
What is it?
The iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) consists of two small titanium stents (tiny tubes) that are pre-loaded into a stent delivery tool (Model G2-M-IS injector). During cataract surgery (surgery to remove the natural lens that has become cloudy and caused significant vision loss), these stents are implanted into the eye of patients with primary open angle glaucoma (POAG) to help drain fluid that has built up.
POAG is a type of glaucoma where the eye pressure slowly rises. If not treated, pressure builds up inside the eye and eventually can damage tissue, which may cause blindness.
How does it work?
The iStent inject Trabecular Micro-Bypass System is designed to control eye pressure (intraocular pressure) by creating a drainage pathway from the fluid filled chamber in the front of the eye (anterior chamber) and the major channel that directs fluid out of the eye by bypassing the tissue where the fluid normally flows through.
When is it used?
The iStent inject Trabecular Micro-Bypass System is implanted inside the eye of patients with primary open angle glaucoma (POAG) during cataract surgery.
What will it accomplish?
The iStent inject Trabecular Micro-Bypass System is intended to help relieve pressure in the eye. In the clinical study, 75.8% of patient eyes who received the stents achieved a significant lowering of their eye pressure compared to 61.9% of patient eyes who only had cataract surgery. Patients in the iStent inject group reported fewer adverse events (54.1%) then those who only had cataract surgery (62.2%).
When should it not be used?
The iStent inject Trabecular Micro-Bypass System should not be used in patients who have any of the following conditions:
- quick or sudden increase in eye pressure
- inflammation of the eye tissue (uvea)
- neovascular glaucoma (a severe form of glaucoma that is characterized by an abnormal growth of new blood vessels in the eye)
- noticeable birth irregularities on the front of the eye
- Orbital tumor (tumor in the eye socket)
- thyroid eye disease
- Sturge-Weber Syndrome (neurological/nerve disorder marked by a distinctive port-wine stain on the forehead, scalp or around the eye)
- any other type of condition that may cause elevated pressure in the veins of the eye (episcleral venous pressure)
Additional information (including warnings, precautions, and adverse events):
Summary of Safety and Effectiveness Data (SSED) and labeling are available online: