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iStent gets panel nod

This article was originally published in The Gray Sheet

Executive Summary

An FDA advisory panel July 30 offered strong support to an implantable glaucoma treatment up for PMA approval. The Ophthalmic Devices Panel voted 7-1 that the benefits of Glaukos Corp.'s iStent trabecular micro-bypass stent outweigh the risks. The advisors voted by the same margin that they had reasonable assurance the device would be safe, and 6-2 that there was a reasonable assurance of effectiveness. If approved, iStent would be indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure in patients with mild to moderate open-angle glaucoma who are being treated with ocular hypotensive medication. It would be the first shunt-type device indicated for non-refractory glaucoma, according to FDA. The agency and Glaukos agreed to long-term post-approval studies prior to the meeting, and the panel also recommended that a device registry be established

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