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iStent infinite®

The iStent infinite® Trabecular Micro-Bypass System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. It is a bleb-free procedure and can be performed as standalone or combined with cataract surgery.

iStent infinite® is the only truly micro-invasive and tissue sparing treatment for moderate to advanced glaucoma patients, designed to work continuously, non-reliant on patient compliance and adherence.

iStent infinite® is based on the iStent® technologies with the most robust, diverse, and longest-term data of any Trabecular Micro- Bypass procedure today.

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The Beginning of the Interventional Glaucoma Revolution

With 3 stents preloaded into a next generation injector system for delivery with unlimited opportunities, iStent infinite® is designed to:

  • Offer safe interventional glaucoma for the treatment of moderate to advanced glaucoma patients helping address rampant rates of patient non-compliance and disease progression.
  • Provide powerful technology to help provide IOP reductions in moderate to advanced glaucoma patients with a high preoperative burden1.
  • Deliver predictable procedures with maximum precision in stent implantation through the new generation injector system
  • Restore physiologic outflow by creating arcs of flow spanning up to 8 clock hours (240°) while minimizing tissue disruption-broad coverage vs other MIGS procedures2.

Go With the Flow—Rejuvenate the System

iStent infinite® is designed to maximize outflow while minimizing disruption to natural anatomy by occupying only 3% of Schlemm’s canal, thereby leaving 97% untouched.

This, coupled with a patented multidirectional stent design, helps bypass resistance and restore physiologic outflow.

Intermediate Therapy That Excels Where Other Treatments Have Failed

In the prospective, multicenter, 12-month pivotal trial, patients with a significantly high preoperative treatment burden with more severe glaucoma as compared to other trabecular bypass MIGS pivotal trials1,3,4 underwent standalone iStent infinite® implantation1.

Despite this tough-to-treat population, iStent infinite® delivered exceptional results demonstrating sustained efficacy throughout the course of the study1.

Next Generation Injector System for Optimised Delivery with Unlimited Opportunities

An elegant, precision-engineered injector system allows you to implant 3 wide-flange, anatomically designed stents across 180° of Schlemm’s canal.

Key Advantages to Using Glaukos Trabecular Micro-Bypass Devices:

All With the Exceptional Customer Support You’ve Come to Expect From Glaukos

300+ Peer-Reviewed Publications

iStent devices have established a legacy of excellence over the last 20 years, backed by the most robust, diverse, and longest-term body of clinical evidence for any MIGS procedure available today, driven through clinical rigor and integrity.

Optimized Outflow

Three multidirectional stents designed to restore natural outflow

Clinically Proven

Significant IOP reduction across a wide range of clinical studies

Procedural Elegance

Predictability and precision meet the needs of your practice

Proven Safety

Exceptional intraoperative and postoperative safety

Contact Us Today to Integrate iStent infinite® Into Your Practice

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References:

  1. 1. Sarkisian Jr, Steven R., et al. “Effectiveness and safety of iStent infinite trabecular micro-bypass for uncontrolled glaucoma.” Journal of glaucoma 32.1 (2023): 9-18.
  2. 2. Glaukos Data on File
  3. 3. CyPass. Summary of safety and effectiveness data. Alcon Laboratories, Inc; 2016.
  4. 4. Samuelson TW, Chang DF, Marquis R, et al. A Schlemm canal microstent for intraocular pressure reduction in primary open-angle glaucoma and cataract. Ophthalmology. 2019;126(1):29-37.

iStent infinite® Important Safety Information

Indication for Use

The iStent infinite® System is intended to reduce intraocular pressure safely and effectively in adult patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma. The device is safe and effective when implanted in combination with or without 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/or conventional glaucoma surgery.

Contraindications

The iStent infinite® System 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

Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualisation that could lead to improper placement of the stent and pose a hazard.

MRI Information

The iStent infinite® System 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 IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic.

Adverse Events

The most common postoperative adverse events reported in the iStent infinite® pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%).

Caution

For prescription use only. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.