The device consists of the small CyPass micro-stent which is pre-loaded into the CyPass applier stent delivery tool.
The shunt is implanted to control eye pressure by creating a drainage pathway from the inside to the outermost layer of the eye, according to the FDA release.
The FDA approved the device for use in patients with primary open angle glaucoma, according to the release, to prevent damage to the optic nerve which can cause blindness.
Data from a study of 505 patients, 374 of which underwent a treatment with the CyPass stent and cataract surgery and 131 who underwent cataract surgery alone, indicated that 72.5% patients treated with the CyPass micro-stent achieved significantly lower IOP compared to those who underwent surgery alone.
Reductions in IOP lasted through the 2-year long study, according to the FDA, with complications occurring in 39.3% of CyPass patients and 35.9% of patients who underwent cataract surgery alone.
The agency said patients who have types of glaucoma other than primary open angle glaucoma, or those with eye anatomies or conditions that are unusual should not use the device.