Technology Overview
iStent® Trabecular Micro-Bypass overview
The iStent is the first ab interno micro-bypass implant for the treatment of glaucoma. The investigational device is currently undergoing FDA review and is not available for use in the United States. The iStent is CE marked and available for use in select countries in Europe. In Canada, the iStent was recently approved for use.
The iStent is custom designed for optimal fit and retention within Schlemm’s canal. The device is made of surgical grade nonferromagnetic titanium, weighs 60 µg with a snorkel bore diameter of 120 µm, and has measurements of 0.5 mm x 0.25 mm x 1.0 mm.
Measuring approximately 1 mm in length, the iStent is the smallest medical device ever implanted into the human body.
Mechanism of action
Elevated or uncontrolled IOP is the number one risk factor for glaucoma. The primary cause of elevated eye pressure in patients with primary open-angle glaucoma is abnormality of the trabecular meshwork which creates resistance to outflow and back-up of aqueous humor. Up to 75% of resistance to outflow is located in the trabecular meshwork.1
Implantation of the iStent bypasses the trabecular meshwork and is placed in Schlemm’s canal near the lower nasal quadrants. The lower nasal quadrants have a large presence of collector channels. The iStent creates a patent bypass through the trabecular meshwork and into Schlemm’s canal; thereby reestablishing physiological outflow.2,3
Future innovations
Glaukos is developing a portfolio of micro-bypass stents to improve upon the safety and efficacy outcomes of minimally invasive, surgical implant procedures. The clinical objective of the Glaukos product portfolio is to provide patients across all stages of glaucoma with minimally invasive, sustainable therapies while decreasing the risk for vision loss. Advances in delivery devices and targeted stent placement within Schlemm’s canal may further optimize micro-bypass stent therapy and improve the efficiency of the procedure. Our goal is to provide physicians with a titratable, minimally invasive, surgical system to reduce IOP and alleviate medication dependence for their patients.
References:
The iStent is the first ab interno micro-bypass implant for the treatment of glaucoma. The investigational device is currently undergoing FDA review and is not available for use in the United States. The iStent is CE marked and available for use in select countries in Europe. In Canada, the iStent was recently approved for use.
The iStent is custom designed for optimal fit and retention within Schlemm’s canal. The device is made of surgical grade nonferromagnetic titanium, weighs 60 µg with a snorkel bore diameter of 120 µm, and has measurements of 0.5 mm x 0.25 mm x 1.0 mm.
Measuring approximately 1 mm in length, the iStent is the smallest medical device ever implanted into the human body.
Mechanism of action
Elevated or uncontrolled IOP is the number one risk factor for glaucoma. The primary cause of elevated eye pressure in patients with primary open-angle glaucoma is abnormality of the trabecular meshwork which creates resistance to outflow and back-up of aqueous humor. Up to 75% of resistance to outflow is located in the trabecular meshwork.1
Implantation of the iStent bypasses the trabecular meshwork and is placed in Schlemm’s canal near the lower nasal quadrants. The lower nasal quadrants have a large presence of collector channels. The iStent creates a patent bypass through the trabecular meshwork and into Schlemm’s canal; thereby reestablishing physiological outflow.2,3
Future innovations
Glaukos is developing a portfolio of micro-bypass stents to improve upon the safety and efficacy outcomes of minimally invasive, surgical implant procedures. The clinical objective of the Glaukos product portfolio is to provide patients across all stages of glaucoma with minimally invasive, sustainable therapies while decreasing the risk for vision loss. Advances in delivery devices and targeted stent placement within Schlemm’s canal may further optimize micro-bypass stent therapy and improve the efficiency of the procedure. Our goal is to provide physicians with a titratable, minimally invasive, surgical system to reduce IOP and alleviate medication dependence for their patients.
References:
- Rosenquist R, Epstein D, Melamed S, Johnson M, et al. Outflow resistance of enucleated human eyes at two different perfusion pressures and different extents of trabeculotomy. Curr Eye Res. 1989;8:1233-1240.
- Dvorak-Theobald G. Schlemm's Canal: Its Anastomoses and Anatomic Relations. Trans Am Ophthalmol Soc. 1934;32:574-595.
- Bahler CK, Smedley GT, Zhou J, et al. Trabecular bypass stents decrease intraocular pressure in cultured human anterior segments. Am J Ophthalmol. 2004;138:988-994.
Costs in Canada $800-$1000/eye: not covered by Ontario provincial medical insurance.
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