Clinical Data

Clinical Data for iStent infinite®

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® implantation.1

Of note, patients enrolled in this study had a significantly higher preoperative treatment burden with more severe glaucoma as compared to other trabecular bypass MIGS pivotal trials.1,3,5

Average patient characteristics in the iStent infinite® pivotal trial1:

Despite this tough-to-treat population, iStent infinite® delivered exceptional results demonstrating sustained efficacy throughout the course of the study.1

* Reduction from baseline at 12 months on the same or fewer medications.

Safety Without Compromise in Tough-to-Treat Patients Prone to Complications

In the 12-month pivotal trial, exceptional intraoperative and postoperative safety was demonstrated among patients with 2 or more failed filtering surgeries1,4:

Safety

For a complete list of postoperative adverse events, please review the Important Safety Information in the Instructions for Use.

  1. Glaukos Data on File
  2. Malihi M, Moura Filho ER, Hodge DO, Sit AJ. Long-term trends in glaucoma-related blindness in Olmsted County, Minnesota. Ophthalmology. 2014;121(1):134–41
  3. CyPass. Summary of safety and effectiveness data. Alcon Laboratories, Inc; 2016.
  4. iStent infinite. Instructions for use. Glaukos Corporation; 2022.
  5. 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.

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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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