FDA Panel Recommends Glaukos iStent for Premarket Approval
August 16, 2010
The FDA ophthalmic devices advisory panel recently recommended premarket approval for the Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS–100 L/R after determining that its benefits outweighed its risks. The iStent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in subjects with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication.
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