Advancing Innovation in MIGS

Glaukos founded the MIGS category 20 years ago with the first-generation iStent. The iStent platform now has the longest-term body of evidence of any MIGS procedure. Due to its broad compatibility with other procedures, iStent remains the first choice for mild-tomoderate glaucoma management.

The standalone, implantable iStent infinite^®* is the latest iteration of this ground-breaking technology. With three anatomically designed stents preloaded into an injector system, the device’s powerful technology delivers foundational, 24/7, long-term control of IOP in patients with glaucoma who have failed prior medical and surgical intervention.

Ike K. Ahmed, Director of the Glaucoma & Advanced Anterior Segment Surgery (GAAS) Fellowship, has noted that “glaucoma is early only once, and surgeons have a timelimited opportunity to intervene early.” iStent infinite^® allows for earlier surgical intervention in glaucoma because of its favorable benefit-risk ratio. It is not restricted to mild-to-moderate patients – unlike some other implantable devices and previous generation iStent technologies. iStent infinite^® provides the versatility to treat a variety of patients, including those that are tough to treat. In a prospective, multi-center, 12-month pivotal trial, for example, patients with open-angle glaucoma who had failed prior medical and surgical intervention – and who had a significantly higher preoperative treatment burden with more severe glaucoma compared to other trabecular bypass MIGS pivotal trials – underwent standalone iStent infinite^® implantation. Of these patients, 73.4 percent showed a ≥ 20 percent reduction in IOP, while 47.3 percent showed a ≥ 30 percent reduction in IOP. The device demonstrated sustained efficacy throughout the course of the study, as well as exceptional intraoperative and postoperative safety (1). 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. Coupled with its patented multidirectional stent design, this helps bypass trabecular resistance and restore physiologic outflow. The device’s injector system was evolved to allow an unlimited number of stent delivery attempts, giving surgeons confidence and peace of mind, no matter where they are in their learning curve.

Standalone glaucoma patients have limited micro-invasive options to treat their condition. Developed with these patients in mind, iStent infinite^® addresses that gap in the treatment algorithm. It offers a safe, truly micro-invasive alternative to medications and more invasive glaucoma treatment procedures. And being the first FDA-cleared device that does not need to be implanted at the time of cataract surgery, iStent infinite^® can also be used on phakic and pseudophakic patients. It represents the beginning of the interventional glaucoma revolution!

iPRIME and iAccess
 

In addition to the iStent platform, Glaukos’ innovation in ophthalmic surgery continues apace with its iAccess and iPRIME technology. The iAccess^® Precision Blade was designed to open the trabecular meshwork over an area >90° to directly access Schlemm’s canal. When medically necessary, precision goniotomy with iAccess^® minimizes tissue disruption and is designed to preserve the eye’s natural blood-aqueous barrier. It can preserve up to 95% more anatomy than other tissue removal procedures (technique dependent) and maintain the eye’s natural blood aqueous barrier and mechanical pump (technique dependent). Earning US FDA 510(k) clearance in 2022, Glaukos’ iPRIME Viscodelivery System is designed to optimize the surgeon’s control. A sterile, single-use minimally invasive viscoelastic fluid delivery device, iPRIME allows surgeons to deliver consistent and controlled amounts of viscoelastic to titrate where, when, and how much viscoelastic they deliver; to administer 2.7μL of viscoelastic with each activation (independent of catheter movement); and to possibly advance past an occlusion by delivering viscoelastic.

Commenting on iPRIME’s FDA clearance, Thomas Burns, Glaukos Chairman and Chief Executive Officer, noted that the new technology “is consistent with our longstanding position on the value of truly minimally invasive therapy.”

* iStent infinite^® is currently only available in the USA and Canada.

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.

PM-US-1634