Health Problem: Glaucoma is a disease of the optic nerve characterized by loss of retinal ganglion cells; remodeling of the lamina cribrosa; structural changes to the nerve; elevated intraocular pressure; and progressive, irreversible loss of vision, leading to blindness. Open-angle glaucoma (OAG) is associated with partial blockage of the flow of aqueous humor.

Technology Description: The XEN Glaucoma Treatment System includes the XEN45 Gel Stent and a preloaded XEN Injector. The XEN Gel Stent is composed of gelatin derived from porcine skin that has been formed into a tube and cross-linked with glutaraldehyde to retain its shape. In its dry state, the stent is 6 millimeters long and has inner and outer diameters of 45 and 150 micrometers, respectively. The stent enlarges and becomes flexible when hydrated. After implantation, the stent becomes a permanent channel through the sclera, allowing aqueous humor to flow from the anterior chamber of the eye into the subconjunctival space, thereby reducing intraocular pressure (IOP).

Controversy: Many surgical procedures are associated with pain, infection, hypotony, hemorrhage, corneal edema, and visual disturbances. For these reasons, minimally invasive approaches are sought. However, controversy surrounds the comparative effectiveness of minimally invasive glaucoma surgeries, such as the XEN Gel Stent, and whether the long-term effect of such procedures will result in reduced use of glaucoma medications.

Key Questions:

  • Is the XEN Gel Stent effective in managing OAG?

  • How does the XEN Gel Stent compare with clinical alternatives in the management of OAG?

  • Is the XEN Gel Stent safe?

  • Have definitive patient selection criteria been identified for the XEN Gel Stent?

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