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Glaukos Awaits iStent Approval, And New Randomized Trial Requirement

This article was originally published in The Gray Sheet

Executive Summary

Glaukos will likely have to conduct a new, five-year prospective randomized post-market study for its iStent glaucoma device if FDA approves the product's PMA

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New Products In Brief

Recent market launches and clearances include Glaukos’ iStent for glaucoma, Beckman Coulter’s Prostate Health Index blood test for prostate cancer and Siemens’ Sysmex CA-600 Systems for lab hemostasis testing.

iStent gets panel nod

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

Health And Wellness Weekly Trademarks Review: 207February

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.


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