New Products In Brief

Ophthalmic device maker Glaukos Corp. receives PMA approval June 25 for its iStent trabecular micro-bypass stent system. It is the first device approved for use in combination with cataract surgery to reduce intraocular pressure in adult patients with mild to moderate open-angle glaucoma and a cataract who are currently being treated with medication. The Laguna Hills, Calif.-based company said it will initially limit U.S. availability to trial investigators and advisors in the short term, with plans for a full market launch at the 2012 American Academy of Ophthalmology Annual Meeting in Chicago, Nov. 10-13. The small (1 mm x 0.3 mm), titanium, L-shaped iStent is designed to facilitate the eye’s natural, physiologic fluid outflow. It received European CE Mark approval in 2004 and has been commercially available in Europe and Canada since 2009. FDA approval was based on a randomized pivotal trial that included 240 eyes from 29 U.S. investigational sites, as well as safety data from another 50 patients added to the same study after randomization. The device gained FDA advisory panel endorsement in July 2010. (See Also see "Glaukos Awaits iStent Approval, And New Randomized Trial Requirement" - Medtech Insight, 9 August, 2010..)

The iStent system is comprised of a titanium stent (pictured) preloaded in a single-use, sterile insertion device.