Ivantis Inc. recently announced the U.S. FDA has granted the company clearance to initiate a second investigational device exemption (IDE) clinical trial for its Hydrus™ Microstent device, designed to lower eye pressure for glaucoma patients.
The new trial will reportedly allow Ivantis to study the Hydrus Microstent in more challenging glaucoma cases, and will include patients with advanced glaucoma, undergoing stand-alone glaucoma surgery without combined cataract surgery. Ivantis is reportedly conducting this study to show that the Hydrus Microstent can combine the efficacy required for a later-stage approach with the safety surgeons demand for the treatment of early-stage patients.
The Hydrus Microstent is reportedly a minimally invasive glaucoma surgery MIGS device designed to reduce eye pressure by reestablishing Schlemm's canal. The device reportedly opens a bypass through the trabecular meshwork — the Hydrus then dilates and scaffolds Schlemm's canal to augment outflow, and spans 90 degrees of the canal to provide expanded access to the eye's fluid collector channels.
Image courtesy Ivantis
Click here to read the full press release.
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