Glaukos has submitted a premarket approval application to the FDA for its iStent inject trabecular micro-bypass stent, according to a company press release.
The iStent inject, designed to improve aqueous humor outflow into Schlemm’s canal and reduce IOP in patients with open-angle glaucoma undergoing cataract surgery, includes two heparin-coated titanium stents preloaded into an auto-injection system. Surgeons can inject the stents into multiple trabecular meshwork locations through a single corneal entry point, the release said.
In a prospective clinical trial of 505 subjects randomized
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