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iStent inject® W Innovative Design

Small Device. Big Results.

One of the World’s Smallest Medical Implants Delivers BIG Results

iStent inject® W is one of the smallest medical implants known to be implanted in the human body and can effectively lower intraocular pressure (IOP), one of the most important risk factors for glaucoma.

Once implanted in the eye, iStent inject® W can help restore normal pressure in the eye. It’s designed to restore your eye’s natural ability to drain the fluid that causes intraocular pressure (IOP) inside your eye. This may allow your doctor to reduce or eliminate your glaucoma medications.

The Size of the iStent inject® W is Only Part of the Story

By increasing your eye’s ability to drain fluid, this technology is designed to:

Restore the Eye’s Natural Outflow Pathway

Lower Intraocular Pressure (IOP)

Reduce or Eliminate Your Need for Glaucoma Medication

At the discretion of your eyecare professional

Clinical Data for iStent inject® W

iStent inject® W builds on the trabecular micro-bypass technology of iStent inject, which has demonstrated efficacy across a wide range of clinical studies.

%

of Patients Medication-Free 23 Months

In a pivotal trial of iStent inject® implanted at the time of cataract surgery, it was observed that 84% of patients* were medication-free at 23 months.**

 

*Based on responder analysis of patients meeting the primary effectiveness endpoint

**iStent inject® Trabecular Micro-Bypass System: Directions for Use, Part #45-0176.

 

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PM-US-0595

INDICATION FOR USE
The iStent inject® W Trabecular Micro-Bypass System Model G2-W is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild-to-moderate primary open-angle glaucoma.

CONTRAINDICATIONS
The iStent inject® W is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or 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 congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard.

MRI INFORMATION
The iStent inject® W is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details.

PRECAUTIONS
The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure (IOP). The safety and effectiveness of the iStent inject® W have not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, abnormal anterior segment, chronic inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated intraocular pressure (IOP) > 24 mmHg or unmedicated intraocular pressure (IOP) < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents.

ADVERSE EVENTS
Common postoperative adverse events reported in the iStent inject® randomized pivotal trial included stent obstruction (6.2%), intraocular inflammation (5.7% for iStent inject® vs. 4.2% for cataract surgery only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss ≥ 2 lines ≥ 3 months (2.6% vs. 4.2%).

CAUTION
Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.

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