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iStent infinite®

The iStent infinite® Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.

iStent infinite® is the first micro-invasive standalone implantable alternative.

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The Beginning of the Interventional Glaucoma Revolution

With 3 anatomically designed stents preloaded into an elegant injector system, iStent infinite® is a first-of-its-kind, standalone implantable alternative designed to:

  • Provide powerful technology to deliver foundational, 24/7, long-term control of IOP in patients with glaucoma who have failed prior medical and surgical intervention1
  • Safely offer interventional glaucoma, a truly micro-invasive alternative to medications and more invasive procedures
  • Restore physiologic outflow by creating arcs of flow spanning up to 8 clock hours (240°) while minimizing tissue disruption—broad coverage vs other MIGS procedures1
  • Provide you the versatility to treat a variety of patients

Illustration is not representative of actual anatomical structures.

Go With the Flow—Rejuvenate the System

Illustration is not representative of actual anatomical structures.

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.

Illustration is not representative of actual anatomical structures.

Intermediate Therapy That Excels Where Other Treatments Have Failed

In the prospective, multicenter, 12-month pivotal trial, patients with open-angle glaucoma who had failed prior surgical intervention underwent standalone iStent infinite® implantation1.

Despite this tough-to-treat population, iStent infinite® delivered exceptional results demonstrating sustained efficacy throughout the course of the study, as well as exceptional intraoperative and postoperative safety1.

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Elegantly Precise Microsurgery

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:

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

Safety Without Compromise

Exceptional intraoperative and postoperative safety

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

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Treatment Options

iStent infinite® is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed. Through this procedure, you may be able to provide your patients with better IOP control and a reduced dependence on medication.

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Reimbursement Support

Tailor-Made Market Access Solutions

Looking for reimbursement info? GPS (Glaukos Patient Services) provides strategic and trustworthy market access solutions for all Glaukos procedures and products in glaucoma, corneal health, and retinal disease care.

Reimbursement Info

Resources for Healthcare Professionals

Resources to Help You Make Informed Decisions

As a trusted industry leader – and the corporate founder of MIGS – we have the experience, tools, and training to make integration easy, starting with the resources we make available to you.

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Contact Us Today to Integrate iStent infinite® Into Your Practice

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iStent infinite® Important Safety Information

Indication for Use

The iStent infinite® Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.

Contraindications

The iStent infinite is contraindicated in eyes with angle-closure glaucoma where the angle has not been surgically opened, acute traumatic, malignant, active uveitic, or active 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 that could lead to improper placement of the stent and pose a hazard.

MRI Information

The iStent infinite 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

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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