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Medical Devices / Submissions and Approvals

FDA Approves Glaukos’ IDE Pivotal Trial for Micro-Bypass System

Dec. 28, 2017

The FDA approved Glaukos’ investigational device exemption pivotal clinical trial of its iStent SA trabecular micro-bypass system.

The system is intended to be used as a standalone procedure for reducing intraocular pressure in patients who previously underwent cataract surgery.

It consists of two micro-scale titanium stents in an auto injection system designed to restore physiological outflow.

Glaukos plans to enroll about 400 subjects and compare the iStent SA system to selective lase trabeculoplasty procedures.

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