MIGS

Redefining Glaucoma Surgery with MIGS

Advances in the development of Micro-Invasive Glaucoma Surgery (MIGS) have brought new excitement to glaucoma treatment. Most commonly used in patients with mild-to-moderate open-angle glaucoma undergoing cataract surgery, MIGS refers to a group of surgical procedures that share the following features.

  • Minimal trauma
  • Efficacy
  • High safety profile
  • Rapid recovery

MIGS is recognized as a micro-invasive treatment option that can reestablish the eye’s physiological outflow, in order to reduce intraocular pressure (IOP).1

Many physicians agree that restoring physiological outflow is preferable in the majority of patients. Compared to more invasive glaucoma surgeries with high complications and risks prolonged with postoperative recovery, MIGS procedures have minimal morbidity, fast recovery, and few complications.2*

As the corporate founder of MIGS, Glaukos revolutionized the traditional glaucoma treatment and management paradigm with the iStent® Trabecular Micro-Bypass Stent—the first MIGS device approved by the FDA. And with the FDA approval of iStent inject® and now iStent inject® W – the next-generation Glaukos trabecular micro-bypass technology – Glaukos continues to advance the standard of care for glaucoma patients.

Many physicians agree that restoring physiological outflow is preferable in the majority of patients. Compared to more invasive glaucoma surgeries with high complications and risks prolonged with postoperative recovery, MIGS procedures have minimal morbidity, fast recovery, and few complications.2*

As the corporate founder of MIGS, Glaukos revolutionized the traditional glaucoma treatment and management paradigm with the iStent® Trabecular Micro-Bypass Stent—the first MIGS device approved by the FDA. And with the FDA approval of iStent inject® and now iStent inject® W – the next-generation Glaukos trabecular micro-bypass technology – Glaukos continues to advance the standard of care for glaucoma patients.

*Indications for MIGS are different compared to invasive glaucoma surgeries and do not include patients with advanced disease or patients who require very low unmedicated postoperative IOP.

  1. Saheb H. Ahmed II. Micro-invasive glaucoma surgery; current perspectives and future directions. Curr Opin Ophthalmol. 2012; 23(2):96-104.
  2. Gedde SJ, Herndon LW, Brandt JD, et al. Postoperative Complications in the Tube Versus Trabeculectomy (TVT) Study During Five Years of Follow-up. Am J Ophthalmol. 2012;153(5):804-814.e1. doi:10.1016/j.ajo.2011.10.024.

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presented at ARVO 2021

Five posters presented at ARVO 2021 highlight the efficacy and safety of the iStent platform as compared to other procedures.

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iDose® TR (travoprost intracameral implant)
Important Safety Information

Dosage And Administration

For ophthalmic intracameral administration. The intracameral administration should be carried out under standard aseptic conditions.

Contraindications

iDose TR is contraindicated in patients with active or suspected ocular or periocular infections, patients with corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal guttatae), patients with prior corneal transplantation, or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]), patients with hypersensitivity to travoprost or to any other components of the product.

Warnings And Precautions

iDose TR should be used with caution in patients with narrow angles or other angle abnormalities. Monitor patients routinely to confirm the location of the iDose TR at the site of administration. Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent.

Adverse Reactions

In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperaemia, and reduced visual acuity.

Indications And Usage

iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Please see full Prescribing Information.

You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also call Glaukos at 1-888-404-1644.

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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