Device Dossier

Glaucoma micro-stent

Device Dossier for Glaucoma micro-stent (Glaucoma micro-stent, Class IIb, sponsor Alcon Laboratories). ARTG record, intended purpose, GMDN category —…

Intended purpose

The Hydrus Microstent is intended for use in adult patients with primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma who require intraocular pressure reduction and/or would benefit from a reduction of glaucoma medications. The Hydrus Microstent may be implanted in patients undergoing concomitant cataract surgery or who have elevated intraocular pressure despite prior treatment with glaucoma medication, and/or a history of prior cataract or glaucoma surgery. The Hydrus Microstent is designed to provide a bypass through the trabecular meshwork for aqueous outflow, providing approximately 90 degrees dilation of Schlemm’s canal. This TM bypass and scaffolding of the canal are intended to restore aqueous outflow through the conventional pathway thereby reducing intraocular pressure in open-angle glaucomatous eyes. The Hydrus Microstent is intended for use by a trained ophthalmic surgeon.

TGA Public Summary