This document addresses surgical devices used in the treatment of glaucoma (open-angle glaucoma; refractory, primary and secondary) to reduce intraocular pressure (IOP). Intraocular anterior segment aqueous drainage devices include:

• Ex-PRESS^® Glaucoma Filtration Device, previously known as the Ex-PRESS™ Mini Glaucoma Shunt (Alacon^®, Irvine, CA)
• Hydrus^® Microstent (Ivantis, Inc., Irvine, CA)
• iStent infinite Trabecular Micro-Bypass System, Model iS3 (Glaukos^® Corp., Laguna Hills, CA)
• iStent inject^® Trabecular Micro-Bypass System (Glaukos^® Corp., Laguna Hills, CA)
• iStent Trabecular Micro-Bypass Stent (Glaukos^® Corp., Laguna Hills, CA)
• XEN^® Glaucoma Treatment System (Allergan, Inc., Irvine, CA)

Note: For information about other proposed surgical procedures for treatment of glaucoma see:

• SURG.00095 Viscocanalostomy and Canaloplasty

Medically Necessary:

Insertion of U.S. Food and Drug Administration (FDA) approved Ex-PRESS Glaucoma Filtration Device is considered medically necessary for the treatment of refractory open-angle glaucoma (primary and secondary) when medical therapies have failed to control intraocular pressure.

Implantation of U.S. FDA approved microstent (that is, Hydrus Microstent, iStent Trabecular Micro-Bypass Stent system and the iStent inject Trabecular Micro-Bypass System) in conjunction with cataract surgery is considered medically necessary as a treatment to reduce intraocular pressure in adults with mild to moderate open-angle glaucoma where medical therapies have failed to adequately control intraocular pressure.

Implantation of U.S. FDA approved microstent (that is, XEN Glaucoma Treatment System) is considered medically necessary in individuals with refractory open-angle glaucoma when both medical therapies and previous surgical treatment have failed to control intraocular pressure.

Implantation of U.S. FDA approved microstent (that is, iStent infinite Trabecular Micro-Bypass Stent System, model iS3) is considered medically necessary in individuals with primary open-angle glaucoma when both medical therapies and previous surgical treatment have failed to control intraocular pressure.

Investigational and Not Medically Necessary:

The Ex-PRESS Glaucoma Filtration Device, Hydrus Microstent, iStent infinite Trabecular Micro-Bypass System (Model iS3), iStent Trabecular Micro-Bypass Stent, and the iStent inject Trabecular Micro-Bypass System are considered investigational and not medically necessary for all other indications not listed above as medically necessary.

Anterior segment aqueous drainage devices inserted internally or externally without an extraocular reservoir (other than the Ex-PRESS Glaucoma Filtration Device, the Hydrus Microstent, the iStent infinite Trabecular Micro-Bypass System (Model iS3), the iStent Trabecular Micro-Bypass Stent, the iStent inject Trabecular Micro-Bypass System, and the XEN Glaucoma Treatment System) including the CyPass System are considered investigational and not medically necessary as a method to reduce intraocular pressure for the treatment of glaucoma.