A Standalone MIGS Landmark
The iStent infinite® represents an interventional glaucoma revolution for both surgeons and patients
| 5 min read | Technology
sponsored by Glaukos
The iStent infinite® System contains three intraocular stents that are manufactured from implant-grade titanium
The first trabecular micro-bypass glaucoma stent was developed by Glaukos over two decades ago in 1999, signaling a significant advancement in glaucoma treatment and surgery. Since that time, minimally invasive glaucoma surgery (MIGS) and the iStent devices have gone from strength to strength, and the iStent platform remains the first choice for surgeons operating on mild-to moderate glaucoma patients.* This platform now has the longest-term body of evidence of any MIGS procedure, with various documented trials throughout the years demonstrating immediate and expansive flow postimplantation (1, 2, 3).
The latest iteration of the device, the iStent infinite®, is a perfect choice for those primary open-angle glaucoma (POAG) patients who have failed prior medical and surgical therapy.
The device comes equipped with three anatomically designed stents preloaded into an injector system. Once implanted, the three stents occupy only 3 percent of Schlemm’s canal, leaving 97 percent untouched and minimizing disruption to the natural anatomy of a patient, which in turn offers them a less traumatic surgical experience when compared to other more traditional, invasive glaucoma surgeries. The innovative injector system also allows for unlimited stent delivery attempts, giving confidence and peace of mind, no matter the surgeon’s level of experience.
To answer the previously unmet need for standalone MIGS implant surgery, the iStent infinite® is the first FDA-cleared implantable device that can be utilized in a standalone procedure, in both phakic and pseudophakic patients. It is a feature of the device that addresses the gap in the interventional glaucoma treatment algorithm and the limited number of micro-invasive options currently available to these patients.
Unlike other implantable devices and previous generation iStent technologies, the iStent infinite® can be used in patients who have failed prior medical and surgical treatment (where invasive surgeries often carry significant post-op risks and complication management, often resulting in more chair time for the patient and more follow-up time for the surgeon). As such, the iStent infinite® is meeting head-on the urgent call of “interventional glaucoma”, providing surgeons who recognize the need to intervene earlier in glaucoma with the means to do so.
Stents are approximately 360 μm in diameter and 360 μm in height
In this current iteration, the iStent infinite® represents more than the sum of its parts and heralds the interventional glaucoma revolution. It is a first-of-a-kind standalone implantable stent, offering an intermediate alternative to more invasive procedures without being restricted to the stage of glaucoma. The device delivers efficacy in tough-to-treat patients with an unparalleled safety profile, allowing surgeons to safely offer a truly microinvasive alternative, helping to address the rampant rates of patient noncompliance and disease progression associated with the disease.
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. iStent infinite® is currently only commercially available in the USA and Canada. 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.
This is a paid advertorial sponsored by Glaukos.
* Data on file.
PM-US-2406
- AM Fea, “Phacoemulsification versus phacoemulsification with microbypass stent implantation in primary open-angle glaucoma: randomized double-masked clinical trial,” J Cataract Refract Surg, 36, 407 (2010). PMID: 20202537.
- FH Hengerer et al., “iStent inject Trabecular Micro-Bypass with or Without Cataract Surgery Yields Sustained 5-Year Glaucoma Control,” Adv Ther, 39, 1417 (2022). PMID: 35113323.
- JC Fan Gaskin et al., “Prospective, Randomized Controlled Trial of Cataract Surgery vs Combined Cataract Surgery With Insertion of iStent Inject,” Ophthalmol Glaucoma, 7, 326 (2024). PMID: 38369058.
